Breast CancerNCT00945061
Radiation Therapy in Treating Patients With Recurrent Breast Cancer
A study testing intracavitary balloon brachytherapy and intraoperative radiation therapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- intracavitary balloon brachytherapy and intraoperative radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Sep 2008to 6 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
- Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
- Unifocal breast cancer recurrence
- Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
- Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
- Signed study-specific informed consent prior to study entry.
Who cannot join
- Patients with distant metastatic disease
- Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
- Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
- Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
- Patients with Paget's disease of the nipple.
- Patients with skin involvement.
Show all 11Show fewer
- Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
- Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study.
- Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
- Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
UHHS Westlake Medical Center
Cleveland, Ohio, 44145
About this study
Official title: Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.
PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.
Read the detailed description
OBJECTIVES:
- To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.
- To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.
- To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
- To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
- To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.
OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.
All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity.
- Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
- Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.
Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.
- Conditions
- Breast Cancer
- Being tested
- intracavitary balloon brachytherapy, intraoperative radiation therapy
- Keywords
- ductal breast carcinoma in situ, recurrent breast cancer, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, male breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracavitary balloon brachytherapyRadiation
Patients undergo brachytherapy
intraoperative radiation therapyRadiation
Patients undergo radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative radiation therapy | Experimental | Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed. Receives: Radiation: intraoperative radiation therapy |
| Intracavitary balloon brachytherapy | Experimental | Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days. Receives: Radiation: intracavitary balloon brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 1 month after radiation therapy (RT)
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 3 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 6 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 9 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 12 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 2 years after RT
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 3 years after RT
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 4 years after RT
Ipsilateral Breast Tumor Recurrence Rates
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Measured: 5 years after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 1 month after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 3 month after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 6 month after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 12 month after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 2 years after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 3 years after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 4 years after RT
Tumor Bed Recurrence Rates
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Measured: 5 years after RT
Cosmetic Outcome as Determined by an Established Scale
Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes.
Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast
Measured: 1 month after RT & Q3mos for one year and at 5 years
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 1 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 3 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 6 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 9 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 12 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 2 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 3 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 4 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey
Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"
- I am totally satisfied with the treatment and results
- I am not totally satisfied but would choose the same treatment again.
- I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
- I am dissatisfied with my treatment.
Measured: 5 years after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 1 month after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 3 month after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 6 month after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 9 month after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 12 month after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 2 years after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 3 years after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 4 years after RT
Percent of Participants Experiencing Complications After Intervention
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Measured: 5 years after RT
Secondary outcomes (9)
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 1 month after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 3 month after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 6 month after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 9 month after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 12 month after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 2 years after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 3 years after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 4 years after RT
Percent of Participants With Delayed Wound Healing
Wound healing rate, as measured by percent of participants with delayed wound healing
Measured: 5 years after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study start23 Sep 2008
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Lyons, MD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945061
- Sponsor's protocol ID
- CASE11107
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2009
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation
- ClinicalTrials.gov ID
- NCT00945061
- Acronym / sponsor ID
- CASE11107
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, recurrent breast cancer, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, male breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 23 Sep 2008 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.
PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.
Detailed description
OBJECTIVES:
- To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.
- To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.
- To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
- To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
- To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.
OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.
All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity.
- Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
- Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.
Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative radiation therapy | Experimental | Radiation: intraoperative radiation therapyPatients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed. |
| Intracavitary balloon brachytherapy | Experimental | Radiation: intracavitary balloon brachytherapyPatients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
- Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
- Unifocal breast cancer recurrence
- Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
- Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
Key exclusion criteria (11 listed)
- Patients with distant metastatic disease
- Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
- Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
- Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
- Patients with Paget's disease of the nipple.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracavitary balloon brachytherapyPatients undergo brachytherapy | Radiation | Intracavitary balloon brachytherapy |
| intraoperative radiation therapyPatients undergo radiotherapy | Radiation | Intraoperative radiation therapy |
Primary outcome
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 1 month after radiation therapy (RT)
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 3 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 6 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 9 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 12 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 2 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 3 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 4 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Ipsilateral Breast Tumor Recurrence Rates
Time frame: 5 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
Tumor Bed Recurrence Rates
Time frame: 1 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Tumor Bed Recurrence Rates
Time frame: 3 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Tumor Bed Recurrence Rates
Time frame: 6 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Tumor Bed Recurrence Rates
Time frame: 12 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Tumor Bed Recurrence Rates
Time frame: 2 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Tumor Bed Recurrence Rates
Time frame: 3 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Tumor Bed Recurrence Rates
Time frame: 4 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Tumor Bed Recurrence Rates
Time frame: 5 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Cosmetic Outcome as Determined by an Established Scale
Time frame: 1 month after RT & Q3mos for one year and at 5 years
Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes. Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 1 month after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 3 month after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 6 month after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 9 month after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 12 month after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 2 years after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 3 years after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 4 years after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Time frame: 5 years after RT
Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" 1. I am totally satisfied with the treatment and results 2. I am not totally satisfied but would choose the same treatment again. 3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. 4. I am dissatisfied with my treatment.
Percent of Participants Experiencing Complications After Intervention
Time frame: 1 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 3 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 6 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 9 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 12 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 2 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 3 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 4 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
Percent of Participants Experiencing Complications After Intervention
Time frame: 5 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
9 secondary outcomes
Percent of Participants With Delayed Wound Healing
Time frame: 1 month after RT
Percent of Participants With Delayed Wound Healing
Time frame: 3 month after RT
Percent of Participants With Delayed Wound Healing
Time frame: 6 month after RT
Percent of Participants With Delayed Wound Healing
Time frame: 9 month after RT
Percent of Participants With Delayed Wound Healing
Time frame: 12 month after RT
Percent of Participants With Delayed Wound Healing
Time frame: 2 years after RT
Percent of Participants With Delayed Wound Healing
Time frame: 3 years after RT
Percent of Participants With Delayed Wound Healing
Time frame: 4 years after RT
Percent of Participants With Delayed Wound Healing
Time frame: 5 years after RT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Lyons, MD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracavitary balloon brachytherapy and intraoperative radiation therapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral Breast Tumor Recurrence Rates (time frame: 1 month after radiation therapy (RT)). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.