Breast CancerPhase 2NCT01082211
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
A Phase 2 study testing 3D-Conformal External Beam in people with Breast Cancer, run by Radiation Therapy Oncology Group at 58 sites in 2 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3D-Conformal External Beam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Jun 2010to 20 May 2022
- 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 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types:
- Invasive ductal breast carcinoma
- Medullary ductal breast carcinoma
- Tubular ductal breast carcinoma
- Mucinous ductal breast carcinoma
- Lobular breast carcinoma
- Ductal carcinoma in situ (DCIS)
- No Paget disease of the nipple
- Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be < 30% based on a post-operative, pre-treatment CT scan
- Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
- Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)
- Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension
- If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed:
- Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment
- Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified)
- Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented
- If the in-breast recurrence is invasive disease and:
- No prior ALN dissection or SLN dissection only:
- Patient is required to undergo axillary evaluation with either a SLN or ALN dissection
- If the SLN is not identified or if the SLN is positive for metastatic disease then an ALN dissection is required
- Patient is eligible for enrollment if encounter 0-3 positive lymph nodes without extracapsular extension
- • Prior ALN dissection: negative clinical exam: patient is eligible for enrollment
- It is recommended, but not required, that the patient undergo ultrasound evaluation of the axilla and the lymph node draining regions of the breast; any suspicious areas are to be biopsied and if positive followed with an ALN dissection
- Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension are encountered
- Prior ALN dissection: positive clinical exam: biopsy required
- If biopsy is negative, patient is eligible for enrollment
- If biopsy is positive an ALN dissection is required
- Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension encountered
- Ipsilateral breast mammogram and MRI within 120 days prior to study entry
- Contralateral breast mammogram within 12 months of study entry
- For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan
- No multicentric ipsilateral breast recurrence or regional recurrence (other than axilla)
- Patients must have a breast technically amenable to partial-breast irradiation
- No metastatic disease documented by physical exam or radiographic evaluation (for patients with invasive disease)
- No skin involvement
- No prior contralateral mastectomy
- Estrogen and progesterone status must be known
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other invasive malignancy within the past 3 years except ipsilateral breast cancer and/or nonmelanoma skin cancer
- No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- No psychiatric or addictive disorders that would preclude obtaining informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior chemotherapy and recovered
- No concurrent intensity-modulated radiotherapy
- No concurrent chemotherapeutic agents, including trastuzumab
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States57 sites
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
JFK Medical Center
Atlantis, Florida, 33462
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
St. Agnes Hospital Cancer Center
Baltimore, Maryland, 21229
Barberton Citizens Hospital
Barberton, Ohio, 44203
Memorial Sloan-Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, 07920
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, 91505
Sands Cancer Center
Canandaigua, New York, 14424
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267
Central Maryland Oncology Center
Columbia, Maryland, 21044
Memorial Sloan-Kettering Cancer Center
Commack, New York, 11725
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
McLaren Cancer Institute
Flint, Michigan, 48532
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Cape Cod Hospital
Hyannis, Massachusetts, 02601
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, 07039
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, 53051
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, 53097
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, 53211
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, 85381
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037
Highland Hospital of Rochester
Rochester, New York, 14620
University Radiation Oncology at Parkridge Hospital
Rochester, New York, 14626
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Memorial Sloan-Kettering Cancer Center - Rockville Centre
Rockville Centre, New York, 11570
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591
Cancer Institute at St. John's Hospital
Springfield, Illinois, 62702
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Barnes-Jewish West County Hospital
St Louis, Missouri, 63141
Flower Hospital Cancer Center
Sylvania, Ohio, 43560
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
Canada1 site
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, T6G 1Z2
About this study
Official title: A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate skin, breast, and chest wall adverse events occurring within 1 year after completion of 3D-conformal partial-breast re-irradiation following repeat breast-preserving surgery in patients with locally recurrent breast carcinoma.
Secondary
- To evaluate the adverse events occurring after 1 year from the completion of re-irradiation and at any time.
- To evaluate in-breast control rate in patients treated with this regimen.
- To evaluate freedom-from-mastectomy rate in these patients.
- To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to document eradication of CTCs by locoregional therapy.
- To determine whether translational objective will correlate with eradication or presence of CTCs with in-breast recurrence and distant metastasis-free survival.
- To evaluate cosmesis as judged by the patient and independent evaluation.
- To evaluate distant metastasis-free survival, mastectomy-free survival, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks.
Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiotherapy for circulating tumor cells analysis.
Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiotherapy.
After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.
- Conditions
- Breast Cancer
- Being tested
- 3D-Conformal External Beam
- Keywords
- invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, invasive lobular breast carcinoma, tubular ductal breast carcinoma, mucinous ductal breast carcinoma, ductal breast carcinoma in situ, lobular breast carcinoma in situ, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Conformal External BeamRadiation
Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.
| Study group | Role | What they receive |
|---|---|---|
| Partial Breast Re-Irradiation | Experimental | Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total Receives: Radiation: 3D-Conformal External Beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events
Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible \& started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable.
Measured: From the end of radiation to 1 year.
Secondary outcomes (12)
In-breast Recurrence
The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above.
Measured: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Freedom From Mastectomy
Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10.
Measured: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs)
CTCs in peripheral blood were assessed using the CellSearch (trademark) system. A stringent algorithm was used to classify cell images as a CTC. A CTC must express EpCAM [epithelial cell adhesion molecule] and not leukocyte lineage-specific antigens, exhibit cytoplasmic expression of cytokeratin, and contain a nucleus that binds DAPI [4',6-doamidino-2-phenylindole]. A cell image is not a CTC if any of the previous criterion are missing. A subject is categorized as "Detectable" if the patient had a CTC and "Undetectable" if the subject had no CTCs. If neither category could be determined, then the subject was categorized as "Unevaluable."
Measured: Prior to the start of radiation and 3 weeks after last radiation treatment.
Treatment-related Adverse Events (AEs) Any Time
AEs were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The overall highest grade for each patient was computed from all reported adverse events definitely, probably, or possibly related to protocol treatment.
Measured: From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis.
Distant Metastasis-free Survival
Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence.
Measured: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years.
Mastectomy-free Survival
Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method.
Measured: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Overall Survival
Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method.
Measured: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation
AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation.
Measured: After 1 year from the end of radiation.
Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)
The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 12 months minus the value at baseline. A positive change reflects a decline at 12 months and a negative change reflects an improvement at 12 months.
Measured: Baseline and 12 months from the start of radiation treatment.
Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)
The Breast Cancer Treatment Outcome Scale (BCTOS) is a 22-item tool to assess cosmetic results using patient self-reports. This brief self-report instrument has high reliability and validity, and it has been used in a variety of previous studies on recovery from breast cancer treatment. It is comprised of three subscales (functional status, cosmetic status, and breast specific pain). Response options for each BCTOS item form a four-point Likert scale evaluating the differences between the treated and the untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 36 months minus the value at baseline. A positive change reflects a decline at 36 months and a negative change reflects an improvement at 36 months.
Measured: Baseline and 36 months from the start of radiation treatment.
Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale
Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale:
Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast.
Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast.
Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast.
Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue.
Measured: Baseline,12, and 36 Months from the start of radiation treatment.
12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale
Patient-Reported BCTOS is comprised of 3 subscales (functional status, cosmetic status, breast specific pain). Responses for each item form a 4-point Likert scale evaluating the differences between the treated and untreated breast (1=no, 2=slight, 3=moderate, 4=large difference). Higher scores reflect poorer outcomes.
Physicians rated cosmesis using a 4 point NRG Oncology/RTOG established criteria scale:
Excellent - when compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast.
Good - there is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast.
Fair - obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast.
Poor - marked change in the appearance of the treated breast involving more than a quarter of the breast tissue.
Measured: 12 Months from the start of radiation treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2014
- Study completion20 May 2022
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.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Douglas W. Arthur, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082211
- Sponsor's protocol ID
- RTOG 1014
- Other IDs
- CDR0000666991
- Status last verified
- May 2022
- First submitted
- 5 Mar 2010
- Last updated
- 21 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma
- ClinicalTrials.gov ID
- NCT01082211
- Acronym / sponsor ID
- RTOG 1014
- Conditions
- Breast Cancer
- Keywords
- invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, invasive lobular breast carcinoma, tubular ductal breast carcinoma, mucinous ductal breast carcinoma, ductal breast carcinoma in situ, lobular breast carcinoma in situ, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- Jun 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Posted 8 Jun 2017
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 to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
Detailed description
OBJECTIVES:
Primary
- To evaluate skin, breast, and chest wall adverse events occurring within 1 year after completion of 3D-conformal partial-breast re-irradiation following repeat breast-preserving surgery in patients with locally recurrent breast carcinoma.
Secondary
- To evaluate the adverse events occurring after 1 year from the completion of re-irradiation and at any time.
- To evaluate in-breast control rate in patients treated with this regimen.
- To evaluate freedom-from-mastectomy rate in these patients.
- To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to document eradication of CTCs by locoregional therapy.
- To determine whether translational objective will correlate with eradication or presence of CTCs with in-breast recurrence and distant metastasis-free survival.
- To evaluate cosmesis as judged by the patient and independent evaluation.
- To evaluate distant metastasis-free survival, mastectomy-free survival, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks.
Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiotherapy for circulating tumor cells analysis.
Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiotherapy.
After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Breast Re-Irradiation | Experimental | Radiation: 3D-Conformal External BeamPartial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 3D-Conformal External BeamRadiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume. | Radiation | Partial Breast Re-Irradiation |
Primary outcome
Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events
Time frame: From the end of radiation to 1 year.
Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible \& started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable.
12 secondary outcomes
In-breast Recurrence
Time frame: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Freedom From Mastectomy
Time frame: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs)
Time frame: Prior to the start of radiation and 3 weeks after last radiation treatment.
Treatment-related Adverse Events (AEs) Any Time
Time frame: From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis.
Distant Metastasis-free Survival
Time frame: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years.
Mastectomy-free Survival
Time frame: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Overall Survival
Time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation
Time frame: After 1 year from the end of radiation.
Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)
Time frame: Baseline and 12 months from the start of radiation treatment.
Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)
Time frame: Baseline and 36 months from the start of radiation treatment.
Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale
Time frame: Baseline,12, and 36 Months from the start of radiation treatment.
12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale
Time frame: 12 Months from the start of radiation treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Douglas W. Arthur, MD principal investigator
Massey Cancer Center
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3D-Conformal External Beam in people with Breast Cancer, run by Radiation Therapy Oncology Group at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada. 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 8 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 Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events (time frame: From the end of radiation to 1 year.). 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 21 Jun 2022.