Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

Status: Recruiting
Phase: Phase 3
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01349322 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-305


RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.


Conducting Institutions:
Massachusetts General Hospital, Massachusetts General Hospital/ North Shore Cancer Center, Lowell General Hospital

Overall PI:
Jeffrey Goldstein, MD, Lowell General Hospital

Site-responsible Investigators:
Alphonse Taghian, MD, PhD, Massachusetts General Hospital
Margarita Racsa, MD, Massachusetts General Hospital/North Shore Cancer Center

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole-breast irradiation (WBI) with boost without regional nodal irradiation planned - Must meet one of the following criteria: - Stage I or II breast cancer AND at least one of the following: - Age < 50 years - Positive axillary nodes - Lymphovascular space invasion (LVI) - More than 2 close resection margins (> 0 mm to ≤ 2 mm) - One close resection margin and extensive in-situ component (EIC) - Focally positive resection margins - Non-hormone-sensitive breast cancer (estrogen-receptor negative (ER-) and progesterone-receptor (PR-) negative) - Grade III histology - Oncotype recurrence score > 25 - Stage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age < 50 years - No DCIS and age > 50 years - No DCIS and age < 50 years and nuclear grade 1 or 2 - Resected by lumpectomy after neoadjuvant systemic therapy - If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins - Breast-conserving surgery with margins defined as follows: - Negative margins defined as no tumor at the resected specimen edge - Close resection margins > 0 mm to ≤ 2 mm as follows: - One close resection margin and EIC - Two or more close resection margins - A focally positive resection margin - Allowable options for mandatory axillary staging include: - Sentinel node biopsy alone (if sentinel node is negative, pN0, pN0[IHC-,+]) - Sentinel node biopsy alone, or followed by axillary node dissection, for clinically node-negative patients as described below: - Microscopic sentinel node (SN) positive (pN1mic) - One or two SNs positive (pN1) without extracapsular extension AND pT1 or pT2 AND no LVI AND at least one additional negative SN - SN biopsy followed by axillary dissection with a minimum total of 6 axillary nodes if any of the following exist: - > 2 positive SN - Solitary SN that is positive without other sentinel nodes dissected - Clinically (by either imaging or examination) T3 disease - Presence of one or more positive SNs with extracapsular extension, clinically node-positive disease, or LVI in the primary tumor - Axillary dissection alone (with a minimum of 6 axillary nodes) - CT-imaging of the ipsilateral breast within 28 days of study entry for the radiation treatment planning - Must be able to delineate on CT scan the extent of the target lumpectomy cavity for boost (placement of surgical clips to assist in treatment planning of the boost is strongly recommended) - No clinical evidence for distant metastases, based upon the following minimum diagnostic workup: - History/physical examination, including breast exam and documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry - Bilateral mammogram within 6 months prior to study entry - No prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible) - No American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, or M1 breast cancer - Must not have two or more breast cancers that are not resectable through a single lumpectomy incision - No invasive breast cancer and low-risk (see low risk features below) for 5-year in-breast recurrence after lumpectomy with negative margins, defined as: - ≥ 70 years old, T1, N0, ER/PR+ - > 50 years old, T1, N0, grade 1-2 breast cancer, ER/PR+ - No suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign - No non-epithelial breast malignancies such as sarcoma or lymphoma - No Paget disease of the nipple - No male breast cancer PATIENT CHARACTERISTICS: - ANC ≥ 1,800/mm³ - Platelet count ≥ 75,000/mm³ - Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable) - Negative serum pregnancy test within 14 days of study entry - Women of childbearing potential must not be pregnant or nursing and willing to use medically acceptable form of contraception during radiotherapy - No prior invasive non-breast malignancy (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to registration - No severely active co-morbidity, defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Transmural myocardial infarction within the past 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol - Acquired Immune-Deficiency Syndrome (AIDS) based upon current CDC definition - HIV testing is not required for entry into this protocol - No active systemic lupus, erythematosus, or any history of scleroderma or dermatomyositis with active rash - Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Study entry must be within 42 days of last breast/axillary surgery and/or last chemotherapy - No treatment plan that includes regional node radiotherapy - No prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation therapy fields - No intention to administer concurrent chemotherapy for current breast cancer
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