Phase 2
N=65
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01082211 ↗Enrolled (actual)
65
Serious AEs
5.2%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3D-Conformal External Beam (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events |
1 | — |
| SECONDARY In-breast Recurrence |
3.7 | 0.0002 sig |
| SECONDARY Freedom From Mastectomy |
5.2 | — |
| SECONDARY Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs) |
8; 32; 7; 8; 26; 13 | — |
| SECONDARY Treatment-related Adverse Events (AEs) Any Time |
0; 0; 10.3; 32.8; 41.4 | — |
| SECONDARY Distant Metastasis-free Survival |
94.8 | — |
| SECONDARY Mastectomy-free Survival |
89.7 | — |
| SECONDARY Overall Survival |
94.8 | — |
| SECONDARY Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation |
0; 0; 6.9; 22.4; 24.1 | — |
| SECONDARY Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) |
0.04; 0.09; -0.21 | — |
| SECONDARY Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS) |
-0.02; 0.19; -0.20 | — |
| SECONDARY Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale |
26; 22; 14 | — |
| SECONDARY 12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale |
1.03; 1.67; 1.33; 1.14; 1.88; 1.53 | 0.054 |
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.
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01082211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.