A Study of Surgery and Radiotherapy in People With Breast Cancer

NCT ID: NCT07053085

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2029-09-17

Brief Summary

The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic HER2-positive breast cancer than the usual approach alone. The researchers will also study the side effects of the study treatment.

Detailed Description

Prior to randomization, patients will receive standard of care first-line systemic therapy as defined by NCCN guidelines (paclitaxel, trastuzumab and pertuzumab at the time of study activation). Following a 3-12 month period without evidence of progression as determined by the treating clinician, patients may be registered and then randomly assigned in 1:1 fashion to one of two study arms. All patients will be followed until progression of disease or 3 years after randomization, whichever comes first. All HER2-directed agents are FDA-approved and administered per standard of care practice.

Conditions

Metastatic Breast Cancer; HER2-positive Breast Cancer

Study Design

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

Study Groups

Standard of care arm

Continuation of first-line systemic therapy will receive the usual approach (drug therapy). Patients will be assigned to the continuation of first-line systemic therapy for an indefinite period per the standard of care. Escalation of systemic-therapy line is at the discretion of the treating physician per standard of care.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Consolidation arm

Patients will receive surgery, locoregional radiation therapy, SBRT, and the usual approach

Group Type: EXPERIMENTAL

Lumpectomy or mastectomy

Intervention Type: PROCEDURE

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)

Radiotherapy

Intervention Type: RADIATION

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

Interventions

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)

Intervention Type: PROCEDURE

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

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Pathologically-confirmed metastatic breast cancer.
• Oligometastatic breast cancer (≤5 discrete metastatic lesions) without CNS involvement; as seen on standard imaging during initial workup and monitoring prior to registration.
• HER2-positive breast cancer per CAP/ASCO guidelines as determined by staff pathologist (any estrogen or progesterone receptor status).
• Based on size and location, all metastatic sites can be safely treated with either SBRT or resection.
• Enrolled at least 3 months (and up to 12 months) after initiation of first-line systemic therapy AND without evidence of progression as determined by treating clinician (whether clinically or radiographically) during this window. (ie. in the judgement of the treating clinician, based on standard evaluations, all known disease must be controlled prior to enrollment).
• ECOG performance status 0-2; KPS 60-100

Exclusion Criteria

• Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician)
• Escalation of systemic therapy line due to progressive disease (i.e. initiated second-line therapy prior to enrollment).
• Comorbidities precluding receipt of radiotherapy, surgery or standard systemic therapy.
• Intracranial or intrathecal/intramedullary spinal disease (ie. CNS involvement is excluded from the study; epidural/vertebral disease is permitted)
• Prior cancer history requiring chemotherapy within the past 10 years (ie. prior cancers are permitted provided no chemotherapy was administered).

Inclusion of Underrepresented Populations

• Individuals of all races and ethnic groups are eligible for this trial. There is no bias towards age or race in the clinical trial outlined. This trial is open to the accrual of men and women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gateway for Cancer Research

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lior Braunstein, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Site Status: RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States

Site Status: RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lior Braunstein, MD

Role: CONTACT

braunstl@mskcc.org

201-775-7446

Atif Khan, MD

Role: CONTACT

848-225-6334

Facility Contacts

Lior Braunstein, MD

Role: primary

201-775-7446

Lior Braunstein, MD

Role: primary

201-775-7446

Lior Braunstein, MD

Role: primary

201-775-7446

Lior Braunstein, MD

Role: primary

201-775-7446

Lior Braunstein, MD

Role: primary

201-775-7446

Lior Braunstein, MD

Role: primary

201-775-7446

Lior Braunstein, MD

Role: primary

201-775-7446

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

25-145

Identifier Type: -

Identifier Source: org_study_id