A Study of Surgery and Radiotherapy in People With Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

September 17, 2025

Primary Completion Date

September 17, 2029

Study Completion Date

September 17, 2029

Conditions
Metastatic Breast CancerHER2-positive Breast Cancer
Interventions
PROCEDURE

Lumpectomy or mastectomy

Resection of the primary breast tumor (ie. lumpectomy when possible or mastectomy when breast conservation not possible). Surgical resection of the primary breast tumor is to be performed per standard guidelines as applied to localized disease. Breast conserving surgery (ie. lumpectomy) is allowable per patient preference when supported by standard surgical practice. Mastectomy is preferred when breast conservation is declined by the patient, or if breast conservation would otherwise not be feasible in the early-stage setting (e.g. large tumor:breast volume ratio, inability to achieve negative margins with breast conservation, etc)

RADIATION

Radiotherapy

"Radiotherapy will be delivered using external beam radiation per the guidelines.Radiotherapy will be delivered using external beam radiation per the guidelines set forth below, targeting two main compartments:~1. Patients will undergo radiotherapy to the breast/chest wall, and regional nodal basins (including the axilla, supraclavicular fossa and internal mammary chain) per the standard adjuvant approach for locally advanced disease, and~2. Patient will undergo stereotactic body radiotherapy (SBRT) or similarly-ablative approaches to sites of distant disease, including all observable foci and those that may have since resolved radiographically during systemic therapy"

DRUG

Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs

Continue to receive the standard treatment you have already started, which includes trastuzumab, pertuzumab, paclitaxel, or a combination of these drugs. This treatment is not part of the study and will be decided by your regular treating physician.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre

11725

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ), Commack

07920

RECRUITING

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
collaborator

Gateway for Cancer Research

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT07053085 - A Study of Surgery and Radiotherapy in People With Breast Cancer | Biotech Hunter | Biotech Hunter