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Randomized Trial Testing the Safety and Patient Experience of Short Course Radiation after Mastectomy and Breast Reconstruction for Breast Cancer

This phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage II-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.
Breast
Phase III
Adults
Radiotherapy
Not Available
Chak, Bapsi
National
Vanderbilt University
11-17-2020
Supportive Care
ALLIANCEBREA221505
NCT03414970

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); patients with metaplastic breast cancer are not eligible

Patients will be staged according to the TNM staging system * For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status * For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients; patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy; cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes * Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy; all patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible; N1mic patients are eligible

No prior therapeutic radiation therapy to the chest, neck or axilla; prior radioactive oral iodine is permitted

No prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed

No history of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed

No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis

Negative inked histologic margins from mastectomy pathology (no invasive cells at margin); patients with DCIS at margin are eligible

No significant post mastectomy complications in the ipsilateral breast requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable

Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended)

Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements

Radiation oncologist is NOT planning to utilize a chest wall/scar boost

Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 18 months after radiation

Treating physician and patient must plan to start radiation treatment within the timeframes specified

If a tissue expander is utilized it needs to be a fluid filled expander, NO air expander (unless completely deflated) during radiation therapy

For patients with diabetes, hemoglobin A1C test must have been performed =
No co-existing medical conditions with life expectancy
No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix

Negative pregnancy test (serum or urine beta-human chorionic gonadotropin [HCG]) in women of child-bearing potential =
Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy

Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

Patients must be able to read and comprehend English, in order to be able to complete study questionnaires; however, patients participating through Canadian Cancer Trials Group (CCTG) institutions who can read and comprehend French are eligible

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