Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8

Treatments: Radiation: Hypofractionated Radiation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03624478

NCI-2018-01606 (Registry Identifier)

MC1732 (Other Identifier)

17-004130 (Other Identifier)

Details and patient eligibility

About

This phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before surgery. 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.

Full description

PRIMARY OBJECTIVES:

I. To determine the pathologic complete response (pCR) rate after hypofractionated radiotherapy to the whole breast alone, based on the postsurgical specimen.

SECONDARY OBJECTIVES:

I. To evaluate acute and late toxicity with preoperative radiation including grade >= 2 pneumonitis.

II. To estimate the 5-year locoregional control, distant recurrence, invasive disease-free survival, cause-specific survival, and overall survival.

CORRELATIVE AND EXPLORATORY OBJECTIVES:

I. To evaluate patient-reported outcomes. II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention.

III. Evaluate tumor mutation signatures before and after radiation; correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery.

IV. To describe the pathologic changes seen in breast cancer patients with preoperative radiation.

OUTLINE:

Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.

After completion of study treatment, participants are followed up at 12 weeks, 6, 12, 24, and 36 months, and 5 years after radiation therapy.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological confirmation of breast cancer
• Clinical stage T0-T2 N0 M0
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
• Able to and provides Institutional Review Board (IRB) approved study specific written informed consent
• Study entry must be within 120 days of last biopsy (breast)
• Able to complete all mandatory tests
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Planned breast surgery and indications for whole breast radiotherapy

Exclusion criteria

• Medical contraindication to receipt of radiotherapy
• Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent
• Active systemic lupus or scleroderma
• Pregnancy
• Women of childbearing potential who are unwilling to employ adequate contraception
• Prior receipt of ipsilateral breast or chest wall radiation
• Recurrent breast cancer
• Indications for comprehensive regional nodal irradiation
• No neo-adjuvant therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment (hypofractionated radiation therapy)

Experimental group

Description:

Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.

Treatment:

Radiation: Hypofractionated Radiation Therapy