Recruiting
Phase 2

Surgery, SBRT & Radiation

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07053085

Conditions

Metastatic Breast Cancer

HER2-positive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lumpectomy or mastectomy

Radiotherapy

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

Study Details

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

Study ID

NCT07053085

Start date

Sep 17, 2025

Status verified date

May, 2026

Completion date

Sep 17, 2029

Anticipated

Primary completion date

Sep 17, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: Consolidation arm

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

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)

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

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.

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Lior Braunstein, MD

201-775-7446braunstl@mskcc.org

Atif Khan, MD

848-225-6334

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Lior Braunstein, MD

201-775-7446

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Lior Braunstein, MD

201-775-7446

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Lior Braunstein, MD

201-775-7446

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Recruiting

Commack, New York, United States, 11725

Contacts

Lior Braunstein, MD

201-775-7446

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Lior Braunstein, MD

201-775-7446

Memorial Sloan Kettering Cancer Center (All protocol activites)

Recruiting

New York, New York, United States, 10065

Contacts

Lior Braunstein, MD

201-775-7446

Memorial Sloan Kettering Nassau (Limited protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Lior Braunstein, MD

201-775-7446

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-14.