Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments hypofractionated whole breast irradiation, conventionally fractionated whole breast irradiation
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Collaborator American Society of Clinical Oncology
Start date February 2011
End date February 2018
Trial size 288 participants
Trial identifier NCT01266642, 2010-0559, NCI-2011-00253

Summary

The goal of this clinical research study is to compare how 4 weeks of radiation treatment affects the breast to how 6 weeks of radiation treatment affects the breast. Researchers also want to know about other side effects of radiation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Shorter radiation (Group 1), Hypofractionated Whole Breast Irradiation (HF-WBI)
hypofractionated whole breast irradiation Radiation therapy
42.56 Gy in 16 fractions delivered to the whole breast on consecutive treatment days. Boost of 10 Gy in 4 fractions or 12.5 Gy in 5 fractions delivered on consecutive days beginning on treatment day following completion of whole breast irradiation.
(Experimental)
Standard radiation (Group 2), Conventionally Fractionated Whole Breast Irradiation (CF-WBI)
conventionally fractionated whole breast irradiation Radiation
50 Gy in 25 fractions delivered to whole breast on consecutive treatment days. Boost of 10 Gy in 5 fractions or 14 Gy in 7 fractions delivered on consecutive treatment days, beginning on treatment day following completion of whole breast irradiation.

Primary Outcomes

Measure
Percent Women with Adverse Cosmetic Scores at 3 Years
time frame: 3 years

Eligibility Criteria

Female participants at least 40 years old.

Inclusion Criteria: 1. Pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with DCIS only). (Upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy. For such patients, the criteria for pathologic stage shall be applied to the initial clinical stage) 2. Treatment with breast conserving surgery. 3. Final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin. If the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a reexcision is strongly encouraged. Lobular carcinoma in situ at the final surgical margin will be disregarded. 4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences. 5. Female sex. 6. Attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level I/II axilla with high tangents is allowed). 7. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 8. Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy. Exclusion Criteria: 1. Pathologic or clinical evidence for a stage T3 or T4 breast cancer. 2. Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes. 3. Clinical or pathologic evidence for distant metastases. 4. Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast. 5. Current diagnosis of bilateral breast cancer. 6. History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast. 7. Patients not fluent in English or Spanish. (The Informed Consent will be available in these two languages) 8. Patient is pregnant.

Additional Information

Official title Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer
Principal investigator Benjamin Smith, MD
Description Study Questionnaire and Photographs: If you agree to take part in this study, you will complete questionnaires about your general health and how your breast currently looks and feels. This should take about 15 minutes to complete. Photographs will also be taken of your breast and your doctor will rate the way your breast looks before you begin receiving radiation. You will not be able to be identified in the photographs. The photographs will be kept as part of your medical record. You will also have a physical exam and your medical history will be recorded. Study Groups: You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will receive shorter radiation. Group 2 will receive standard radiation. For shorter radiation (Group 1), you will receive about 3 weeks of radiation (16 treatments) to the entire breast. You will also have 4-5 additional treatments of radiation as a "boost". The boost will be delivered to the part of the breast where the disease first started. For standard radiation (Group 2), you will receive about 5 weeks of radiation (25 treatments) to the entire breast. You will also have 5-7 additional treatments of radiation as a boost to the part of the breast where the disease started. Study Visits: While you are receiving radiation, you will be asked about any side effects you may be having each week. Follow-up Visit: You will return to the clinic for follow-up visits 6 months and 1, 2, 3, 4, and 5 years after you have finished receiving radiation. At each follow-up visit, you will fill out the study questionnaire, more photographs will be taken of your breast, and you will be asked about any side effects you may be having. You will also have a physical exam and your medical history will be recorded. Length of Study: After the 5-year follow-up visit, you will be off study. This is an investigational study. Both the standard and the shorter radiation courses are FDA-approved in patients with breast cancer. The goal of this study is to compare the 2 treatments. Up to 288 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.