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

Summary

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.

Conditions

• 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

Interventions

RADIATION

External Beam Radiation Therapy

Undergo HF-WBI

RADIATION

External Beam Radiation Therapy

Undergo CF-WBI

RADIATION

Hypofractionated Radiation Therapy

Undergo HF-WBI

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Whole Breast Irradiation

Undergo HF-WBI

RADIATION

Whole Breast Irradiation

Undergo CF-WBI

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Benjamin D Smith · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-08

Primary Completion

2020-11-30

Completion

2040-11-30

FDA Drug

Yes

Countries

• United States

Study Locations