Recruiting
Phase 3

Radiation Therapy Comparison

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06960707

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Radiation therapy - 1 week

Radiation therapy - 2 weeks

Study Details

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

Study ID

NCT06960707

Start date

Apr 29, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2040

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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.

Interventions

Radiation therapy - 1 week

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

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.

Primary outcome measure

  • Rate of RT-related acute toxicity [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Fabiana Gregucci, MD

6469623110fgr4002@med.cornell.edu

Fereshteh Talebi, MD

6467027830fet4007@med.cornell.edu

Locations

Brooklyn Methodist Hospital

Recruiting

New York, New York, United States, 11215

Contacts

Izael Nino

(929) 470-9426izn4001@med.cornell.edu

Principal Investigator:

Hani Ashamalla, MD

New York Presbyterian Hospital

Recruiting

New York, New York, United States, 11355

Contacts

Krystalle Lyons

718-670-1541krl4003@med.cornell.edu

Principal Investigator:

Steven DiBiase, MD

New York-Presbyterian Weill Cornell Medical College

Recruiting

New York, New York, United States, 11355

Contacts

Maahi Patel, Bachelors of Science, BS

9784025630map4044@med.cornell.edu

Principal Investigator:

Silvia C. Formenti, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-15.