Two Versus One Week Breast Radiotherapy (RT)

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06960707
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation therapy - 1 week — RADIATION
    2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week
  • 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.

Study Details

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.

Key Dates

Start date
Apr 29, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2040

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brooklyn Methodist HospitalNew YorkNew York11215
Izael Nino
[email protected]
(929) 470-9426
Hani Ashamalla, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian HospitalNew YorkNew York11355
Krystalle Lyons
[email protected]
718-670-1541
Steven DiBiase, MD (PRINCIPAL_INVESTIGATOR)
New York-Presbyterian Weill Cornell Medical CollegeNew YorkNew York11355
Maahi Patel, Bachelors of Science, BS
[email protected]
9784025630
Fabiana Gregucci, MD
Silvia C. Formenti, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brooklyn Methodist Hospital· New York, NYNew York Presbyterian Hospital· New York, NYNew York-Presbyterian Weill Cornell Medical College· New York, NY

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