A Study of Surgery and Radiotherapy in People With Breast Cancer

NCT07053085 | Recruiting Phase 2

• 1 other identifier: 25-145
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 7

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.

Conditions

Metastatic Breast Cancer; HER2-positive Breast Cancer

Keywords

Consolidative surgery; Radiotherapy; Ablation; Resection; 25-145

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  with PFS defined as the time of randomization to the date of clinical or radiographic disease progression or death (by any cause in the absence of progression).

  3 years

Study Arms (2)

Standard of care arm

ACTIVE COMPARATOR

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.

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

Consolidation arm

EXPERIMENTAL

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

Procedure: Lumpectomy or mastectomy; Radiation: Radiotherapy

Interventions

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

Standard of care arm

Lumpectomy or mastectomy 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)

Consolidation arm

Radiotherapy 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

Consolidation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Gateway for Cancer Research: collaborator

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Mastectomy; Radiotherapy; Trastuzumab; pertuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Lior Braunstein, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Braunstein, MD

CONTACT

201-775-7446; braunstl@mskcc.org

Atif Khan, MD

CONTACT

848-225-6334

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 8, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): September 17, 2029
• Study Completion (Estimated): September 17, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)