Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer

Paused · Phase 2/Phase 3

Conditions studied: Ductal Breast Carcinoma In Situ, Early-Stage Breast Carcinoma, Invasive Breast Carcinoma, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, 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 phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.

Key facts

Study ID

NCT03077841

Run by

M.D. Anderson Cancer Center

People needed

928

Starts

2017-03-06

Expected to finish

2027-11-08

Last updated by the study team

2026-03-05

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
• Pathologic T stage of Tis, T1, or T2 with total size of tumor =< 3 cm (this size criteria applies to both pure DCIS and invasive tumors)
• For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
• Treatment with breast conserving surgery
• Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
• Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
• For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor)
• If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month 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 cytotoxic chemotherapy
• Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation

You may not qualify if…

• Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature
• Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
• Systemic chemotherapy prior to final breast conserving surgery
• Patient is pregnant or nursing
• History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
• History of prior invasive or in situ cancer in either breast
• Current diagnosis of bilateral breast cancer
• History of lupus or scleroderma

Where it is running

• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Community Cancer Center East — Indianapolis, Indiana, United States
• Covenant Medical Center Harrison — Saginaw, Michigan, United States
• Summit Medical Group — Berkeley Heights, New Jersey, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• MD Anderson Cancer Center at Cooper-Voorhees — Voorhees Township, New Jersey, United States
• Presbyterian Hospital — Albuquerque, New Mexico, United States
• OhioHealth Mansfield Hospital — Mansfield, Ohio, 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
• Saint Luke's Baptist Health System — San Antonio, Texas, United States
• MD Anderson in Sugar Land — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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