Ductal Breast Carcinoma In SituPhase 2NCT01754519
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
A Phase 2 study testing Therapeutic Conventional Surgery, Radiation Therapy and Laboratory Biomarker Analysis in people with Ductal Breast Carcinoma In Situ and Estrogen Receptor Negative, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive
- What is being tested?
- Therapeutic Conventional Surgery, Radiation Therapy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2015
- Phase
- Phase 2
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and "NOS" (not otherwise specified); invasive lobular cancer is excluded
- Age >= 50 years and postmenopausal with no menses for at least one year prior to study enrollment
- Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility)
- Hormone receptor status
- Estrogen or progesterone receptor positive or
- Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cm
Show all 11Show fewer
- Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysis
- Tumor >= 0.5 cm from skin as defined by breast ultrasound
- Unicentric tumor
- Axillary lymph nodes negative by pre-operative physical examination in all cases and pathologic examination from surgery for invasive disease
- Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation
Who cannot join
- Initial core biopsy showing invasive lobular cancer
- Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm
- Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization [FISH])
- Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2
- Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants
- Clinically or pathologically positive axillary lymph nodes
- Any prior breast cancer
- Prior breast radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose.
SECONDARY OBJECTIVE:
- Locoregional control reported at five years.
OUTLINE:
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then every 6 months for 2 years.
- Conditions
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Invasive Cribriform Breast Carcinoma, Invasive Ductal Carcinoma, Not Otherwise Specified
- Being tested
- Therapeutic Conventional Surgery, Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Conventional SurgeryProcedure or surgery
Undergo wide local excision breast surgery
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo SFRT
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy) | Experimental | Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Receives: Procedure: Therapeutic Conventional Surgery; Radiation: Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.
Measured: Up to 2 years
Quality-of-life Assessments
Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.
Measured: Up to 2 years
Cosmetic Differences in the Treated Breast
Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.
Measured: Up to 2 years
Secondary outcomes (3)
Locoregional Control Rate
Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.
Measured: At 5 years
Overall Survival
The overall survival will be analyzed using Kaplan-Meier method.
Measured: Up to 5 years
Disease Specific Survival
The disease specific survival will be analyzed using Kaplan-Meier method.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: IDE not submitted
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 Ductal Breast Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cianna Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- David Mattson, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754519
- Sponsor's protocol ID
- I 108907
- Other IDs
- NCI-2009-01568, I 108907, P30CA016056
- Status last verified
- Jun 2017
- First submitted
- 23 Nov 2012
- Last updated
- 7 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01754519
- Acronym / sponsor ID
- I 108907
- Conditions
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Invasive Cribriform Breast Carcinoma, Invasive Ductal Carcinoma, Not Otherwise Specified
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDE not submitted
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cianna Medical, Inc.
- Study start
- May 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose.
SECONDARY OBJECTIVE:
- Locoregional control reported at five years.
OUTLINE:
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy) | Experimental | Procedure: Therapeutic Conventional Surgery, Radiation: Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life AssessmentPatients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and "NOS" (not otherwise specified); invasive lobular cancer is excluded
- Age >= 50 years and postmenopausal with no menses for at least one year prior to study enrollment
- Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility)
- Hormone receptor status
- Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysis
Key exclusion criteria (8 listed)
- Initial core biopsy showing invasive lobular cancer
- Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm
- Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization [FISH])
- Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2
- Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants
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 |
|---|---|---|
| Therapeutic Conventional SurgeryUndergo wide local excision breast surgery | Procedure or surgery | Treatment (radiation therapy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo SFRT | Radiation | Treatment (radiation therapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (radiation therapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (radiation therapy) |
Primary outcome
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 2 years
Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.
Quality-of-life Assessments
Time frame: Up to 2 years
Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.
Cosmetic Differences in the Treated Breast
Time frame: Up to 2 years
Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.
3 secondary outcomes
Locoregional Control Rate
Time frame: At 5 years
Overall Survival
Time frame: Up to 5 years
Disease Specific Survival
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- 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.
David Mattson principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Therapeutic Conventional Surgery, Radiation Therapy and Laboratory Biomarker Analysis in people with Ductal Breast Carcinoma In Situ and Estrogen Receptor Negative, run by Roswell Park Cancer Institute at 1 site 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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). 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?
Number of Patients With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 2 years). The study lists 3 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 7 Jul 2017.