Two Versus One Week Breast Radiotherapy (RT)

NCT ID: NCT06960707

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-29
• Study Completion Date: 2040-12-31

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.

Detailed Description

Radiotherapy: one week (Arm 1) 2600 cGy in 5 fractions whole breast radiotherapy over one week versus 2 weeks (Arm 2), 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy. 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.

Hypothesis: A regimen of whole breast radiotherapy to 2600 in five fractions, the current UK standard for early breast cancer (Arm 2), is not inferior to 3200cGy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 1), in terms of acute toxicity and long-term fibrosis, breast cosmesis and local control at 2 and 5 years. It will also test the hypothesis of superior local control at 10 years in Arm 2 compared to Arm 1.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM 1-2600 cGy in 5 fractions whole breast radiotherapy

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

Group Type: EXPERIMENTAL

Radiation therapy - 1 week

Intervention Type: RADIATION

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

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

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

Group Type: EXPERIMENTAL

Radiation therapy - 2 weeks

Intervention Type: 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.

Interventions

Radiation therapy - 1 week

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

Intervention Type: RADIATION

Radiation therapy - 2 weeks

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Women status post segmental mastectomy.

2. If unilateral, pT1-2 breast cancer excised with negative margins.

3. If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.

4. Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.

5. Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

6. Women with previous contralateral treated breast cancer can be enrolled in the trial.

Exclusion Criteria

1. Previous radiation therapy to the ipsilateral breast.

2. >90 days from last surgery, unless s/p adjuvant chemotherapy.

3. >60 days from last chemotherapy.

4. Male breast cancer.

5. Ongoing treatment for severe autoimmune disease.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia C. Formenti, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Brooklyn Methodist Hospital

New York, New York, United States

Site Status: RECRUITING

New York Presbyterian Hospital

New York, New York, United States

Site Status: RECRUITING

New York-Presbyterian Weill Cornell Medical College

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fabiana Gregucci, MD

Role: CONTACT

fgr4002@med.cornell.edu

6469623110

Fereshteh Talebi, MD

Role: CONTACT

fet4007@med.cornell.edu

6467027830

Facility Contacts

Izael Nino

Role: primary

izn4001@med.cornell.edu

(929) 470-9426

Krystalle Lyons

Role: primary

krl4003@med.cornell.edu

718-670-1541

Maahi Patel, Bachelors of Science, BS

Role: primary

map4044@med.cornell.edu

9784025630

Fabiana Gregucci, MD

Role: backup

Other Identifiers

25-01028391

Identifier Type: -

Identifier Source: org_study_id