Two Versus One Week Breast Radiotherapy (RT)

NCT06960707 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: 25-01028391
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

This study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. One group will receive radiation over one week (based on the FAST-FORWARD trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). The study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. It also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.

Conditions

Breast Cancer

Keywords

Accelerated Radiotherapy; Prone Position; Adjuvant Setting; Non-Inferiority; Concomitant Boost

Outcome Measures

Primary Outcomes (1)

• Rate of RT-related acute toxicity

  The rate of RT-related acute toxicity is defined as cumulative acute toxicity events from the start of radiation treatment to 1 month follow up post RT. The toxicities will be graded by the research nurses assigned to the study according to Common Terminology Criteria for Adverse Events, version 5.0.

  1 month

Secondary Outcomes (7)

• The long-term evaluations at 2 years of fibrosis based on LENT/SOMA

  24 months

• The long-term evaluations at 2 years of breast cosmesis

  24 months

• The long-term evaluations at 2 years of local control

  24 months

• The long-term evaluations at 5 years OF fibrosis based on LENT/SOMA

  60 months

• The long-term evaluations at 5 years of breast cosmesis

  60 months

Study Arms (2)

ARM 1-2600 cGy in 5 fractions whole breast radiotherapy

EXPERIMENTAL

Patients randomized to ARM 1 will receive 2600 cGy in 5 fractions whole breast radiotherapy over one week

Radiation: Radiation therapy - 1 week

ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy

EXPERIMENTAL

Patients randomized to ARM 2 will receive 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy.

Radiation: Radiation therapy - 2 weeks

Interventions

Radiation therapy - 1 week RADIATION

2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week

ARM 1-2600 cGy in 5 fractions whole breast radiotherapy

Radiation therapy - 2 weeks RADIATION

3200 cGy whole breast radiotherapy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 2) over 2 weeks. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost.

ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women status post segmental mastectomy.
• If unilateral, pT1-2 breast cancer excised with negative margins.
• If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
• Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.
• Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
• Women with previous contralateral treated breast cancer can be enrolled in the trial.

You may not qualify if:

• Previous radiation therapy to the ipsilateral breast.
• \>90 days from last surgery, unless s/p adjuvant chemotherapy.
• \>60 days from last chemotherapy.
• Male breast cancer.
• Ongoing treatment for severe autoimmune disease.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (3)

Brooklyn Methodist Hospital

New York, New York, 11215, United States

RECRUITING

New York Presbyterian Hospital

New York, New York, 11355, United States

RECRUITING

New York-Presbyterian Weill Cornell Medical College

New York, New York, 11355, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Silvia C. Formenti, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Gregucci, MD

CONTACT

6469623110; fgr4002@med.cornell.edu

Fereshteh Talebi, MD

CONTACT

6467027830; fet4007@med.cornell.edu

Study Design

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

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)