Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery

NCT03324802 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MC1635NCI-2017-01944
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 3

Brief Summary

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing the return of tumor cells in breast cancer patients following 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

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; Stage IIIA Breast Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor

  The complication rate will be reported by arm.

  24 months

Secondary Outcomes (8)

• Cause-specific Survival

  1 year

• Overall Survival

  1 year

• Number of Patients Experiencing Distant Recurrence

  5 years

• Number of Patients Experiencing Acute (Grade 3+) Adverse Events (AEs)

  3 months

• Number of Patients Experiencing Grade 3+ Late Adverse Events

  24 months

Other Outcomes (3)

• Patient Reported Outcomes/Quality of Life

  Up to 5 years

• Patient Reported Outcomes/Quality of Life

  Up to 5 years

• Patient Self-reported Cosmesis

  Baseline up to 5 years

Study Arms (2)

Arm 2 (hypofractionated radiation therapy, 5 fractions)

EXPERIMENTAL

Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 5 daily fractions for 5 days.

Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment

Arm I (radiation therapy, 15 fractions)

EXPERIMENTAL

Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days.

Other: Quality-of-Life Assessment; Radiation: Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated Radiotherapy, hypofractionation

Arm 2 (hypofractionated radiation therapy, 5 fractions)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm 2 (hypofractionated radiation therapy, 5 fractions); Arm I (radiation therapy, 15 fractions)

Radiation Therapy RADIATION

hypofractionated radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm I (radiation therapy, 15 fractions)

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
• Pathologic stage T0-T3N0-N1M0
• 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 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable)
• Able to complete all mandatory tests
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale
• Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy
• Breast conserving 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
• Prior receipt of ipsilateral breast or chest wall radiation
• Positive margins on ink after definitive surgery either for ductal carcinoma in situ (DCIS) or invasive cancer
• History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry
• Recurrent breast cancer
• Indications for comprehensive regional nodal irradiation

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Therapeutics; Physical Phenomena

Results Point of Contact

• Title: Carlos E. Vargas, M.D.
• Organization: Mayo Clinic

Vargas.Carlos@mayo.edu

4803421262

Study Officials

• Carlos Vargas

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 30, 2017
• Study Start: February 7, 2018
• Primary Completion: January 31, 2022
• Study Completion: August 28, 2023
• Last Updated: May 2, 2024
• Results First Posted: June 15, 2023

Record last verified: 2024-04

Locations

US (3)