Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery

NCT03624478 | Completed Phase 2 Results DMC FDA Device

• 3 other identifiers: MC1732NCI-2018-0160617-004130
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR) Rate Defined as a Residual Tumor Burden of 0-1 in the Surgical Specimen

  The proportion of successes (number of patients achieving pCR at time of definitive surgery) will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

  up to 2 years

Secondary Outcomes (8)

• Number of Participants With Acute Adverse Events (AE)

  Up to 180 days post radiation therapy

• Incidence of Late Adverse Events

  Up to 5 years post radiation therapy

• Locoregional Control

  Up to 5 years

• Invasive Disease-free Survival

  From registration until the time of disease recurrence or death due to any cause, assessed up to 5 years

• Distant Recurrence

  Up to 5 years

Other Outcomes (6)

• Patient Self-reporting of Toxicities

  Up to 5 years

• Patient Self-reported Cosmetic Outcomes

  Baseline up to 5 years

• Panel Assessed Cosmetic Outcome

  Baseline up to 2 years

Study Arms (1)

Treatment (hypofractionated radiation therapy)

EXPERIMENTAL

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

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated Radiotherapy, hypofractionation

Treatment (hypofractionated radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Radiation Dose Hypofractionation

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Carlos Vargas
• Organization: Mayo Clinic

Vargas.Carlos@mayo.edu

480-342-1267

Study Officials

• Carlos E. Vargas, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 10, 2018
• Study Start: November 20, 2018
• Primary Completion: June 30, 2021
• Study Completion: September 24, 2025
• Last Updated: November 26, 2025
• Results First Posted: December 15, 2022

Record last verified: 2025-11

Locations

US (3)