Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments circulating tumor cell analysis, laboratory biomarker analysis, questionnaire administration, adjuvant therapy, 3-dimensional conformal accelerated partial breast irradiation
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date June 2010
End date November 2014
Trial size 65 participants
Trial identifier NCT01082211, CDR0000666991, RTOG 1014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 GY x 15 (BID) to 45 Gy Total
circulating tumor cell analysis
laboratory biomarker analysis
questionnaire administration
adjuvant therapy
3-dimensional conformal accelerated partial breast irradiation

Primary Outcomes

Measure
Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events
time frame: From the end of radiation to 1 year.

Secondary Outcomes

Measure
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.
Rate of circulating tumor cells
time frame: Prior to the start of radiation and 3 weeks after last radiation treatment.
All treatment-related adverse events
time frame: After 1 year from the end of radiation and from the end of radiation to end of follow-up.
Cosmesis
time frame: After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years.
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 potientially 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.

Eligibility Criteria

Female participants from 18 years up to 120 years old.

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 - 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 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

Additional Information

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
Principal investigator Douglas W. Arthur, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.