Clinical Trials (PDQ®)
|Phase II||Biomarker/Laboratory analysis, Treatment||Closed||18 and over||NCI, Other||RTOG 1014|
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.
Further Study Information
- 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.
- To evaluate the adverse events at 1 year and at any time of this regimen in these patients.
- 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.
- 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
- Initial lumpectomy followed by whole-breast radiotherapy performed over 1 year ago
- Repeat lumpectomy performed within the past 42 days
- 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
- Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence within the past 120 days and the following must be true:
- Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
- Negative histologic margins of resection and no tumor on ink following breast-preserving surgery
- Re-excision to achieve negative margins allowed
- 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
- No more than 120 days since whole-body 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
- 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 Lead Organizations/Sponsors
Radiation Therapy Oncology GroupNational Cancer Institute
|Douglas W. Arthur||Principal Investigator|
|Monmouth Medical Center|
|Sang Eui Sim||Ph: 732-923-7689|
|Roswell Park Cancer Institute|
|David M Mattson||Ph: 877-275-7724|
|American College of Radiology Imaging Network|
|Douglas W Arthur|
|M. D. Anderson Cancer Center at University of Texas|
|Wendy A Woodward|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01082211
ClinicalTrials.gov processed this data on October 17, 2013
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