Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer

Running, not enrolling · Phase 2

Conditions studied: Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v6, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7

In brief

This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and have fewer side effects. It is not yet known if hypofractionated RT is more effective than standard RT in treating breast cancer.

Key facts

Study ID: NCT01266642
Run by: M.D. Anderson Cancer Center
People needed: 301
Starts: 2011-02-08
Expected to finish: 2040-11-30
Last updated by the study team: 2026-03-11

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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 ductal carcinoma in situ [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)
Treatment with breast conserving surgery
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 re-excision is strongly encouraged; lobular carcinoma in situ at the final surgical margin will be disregarded
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.
Female sex.
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)
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
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 concurrent cytotoxic chemotherapy

You may not qualify if…

Pathologic or clinical evidence for a stage T3 or T4 breast cancer
Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes
Clinical or pathologic evidence for distant metastases
Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast
Current diagnosis of bilateral breast cancer
History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
Patients not fluent in English or Spanish (The BCTOS will be available in these two languages)
Patient is pregnant

Where it is running

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
UF Cancer Center at Orlando Health — Orlando, Florida, United States
MD Anderson in The Woodlands — Conroe, Texas, United States
M D Anderson Cancer Center — Houston, Texas, United States
MD Anderson West Houston — Houston, Texas, United States
MD Anderson League City — League City, Texas, United States
MD Anderson in Sugar Land — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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