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

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01349322

Run by

Radiation Therapy Oncology Group

People needed

2354

Starts

2011-05-24

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole breast irradiation with boost without regional nodal irradiation planned
• The patient must be female
• The patient must meet at least one of the three following criteria:
• A. Pathological stage I, II Breast Cancer AND at least one of the following:
• Age < 50 years or
• Positive axillary nodes or
• Lymphovascular space invasion or
• 2 or more close resection margins (> 0 mm to ≤ 2 mm) or
• 1 close resection margin and extensive intraductal component (EIC) [Per College of American Pathologist (CAP) Recommendation] or
• Focally positive resection margins or
• Non-hormone sensitive breast cancer (estrogen receptor (ER)- and progesterone receptor(PR)-negative) or
• Grade III histology or
• Oncotype recurrence score > 25 or
• B. Pathological stage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age <50 years or
• C. Post-neoadjuvant pathological 0, I, II breast cancer resected by lumpectomy after neoadjuvant systemic therapy
• Study entry must be within 50 days from whichever comes later: last surgery (breast or axilla) or last chemotherapy. The day of surgery is Day "0".
• 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: (also see 3.1.3 for eligibility)
• 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 (per College of American Pathologist (CAP) Recommendation)
• 2 or more close resection margins.
• A focally positive resection margin
• For invasive breast cancer the axilla must be staged by one of the following:
• Sentinel node biopsy alone, if sentinel node is negative, i.e. any of the following:

You may not qualify if…

• American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, M1 pathologic stages III or IV breast cancer
• Treatment plan that includes regional node irradiation
• Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
• Prior invasive or in-situ carcinoma of the breast [-prior lobular carcinoma in situ (LCIS) is eligible]
• Two or more breast cancers not resectable through a single lumpectomy incision
• Bilateral breast cancer
• DCIS only (without an invasive component) and age ≥ 50 years
• DCIS nuclear grade 1 or 2 only (without an invasive component) and age < 50 years
• Invasive breast cancer and low risk for 5-year in breast recurrence after lumpectomy with negative margins that does not meet one of the eligibility factors in 3.1.3.
• Unable 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, see Section 6.4.2 for details)
• Suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
• Non-epithelial breast malignancies such as sarcoma or lymphoma
• Paget's disease of the nipple
• Male breast cancer
• Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation therapy fields
• Intention to administer concurrent chemotherapy for current breast cancer.
• Severe, 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 last 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 Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
• Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
• Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash

Where it is running

• The Kirklin Clinic at Acton Road — Birmingham, Alabama, United States
• 21st Century Oncology-Scottsdale — Scottsdale, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Arizona Oncology Associates-West Orange Grove — Tucson, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• Enloe Medical Center — Chico, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Epic Care-Dublin — Dublin, California, United States
• 21st Century Oncology - El Segundo — El Segundo, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente Oakland-Broadway — Oakland, California, United States
• Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova, California, United States
• Rohnert Park Cancer Center — Rohnert Park, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• The Permanente Medical Group-Roseville Radiation Oncology — Roseville, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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