RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT03077841 Optimizing Preventative Adjuvant Linac-based Radiation: the OPAL Trial A Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women with Early Stage Breast Cancer

Status

Open

Description

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.

Objective

The primary endpoint is the risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with the OPAL regimen. We will evaluate whether or not the risk of this outcome is higher than the risk of grade 2+ toxic events in the best performing arm of our prior clinical trial that evaluated dosing schedules of whole breast irradiation (2010-0559).

Treatment

Experimental: Arm I (hypofractionated partial breast irradiation) Patients undergo hypofractionated partial breast irradiation daily for 10 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor. Other: Laboratory Biomarker Analysis Correlative studies Radiation: Partial Breast Irradiation Undergo hypofractionated partial breast irradiation Other: Questionnaire Administration Ancillary studies Active Comparator: Arm II (hypofractionated partial breast irradiation) Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor. Other: Laboratory Biomarker Analysis Correlative studies Radiation: Partial Breast Irradiation Undergo hypofractionated partial breast irradiation

Conditions

Breast

Phases

II

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Anderson, Cynthia

Practice

Breast

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center

Eligibility

Inclusion Criteria: 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 Exclusion Criteria: 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

Nct ID Number

NCT03077841

Secondary Trial ID Number

2016-1035/OPAL

Keywords

Treatment

More Information

clinicaltrials.gov

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