A Study of Surgery and Radiotherapy in People With Breast Cancer

Conditions

• HER2-positive Breast Cancer
• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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)
• 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
• 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.

Study Details

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.

Key Dates

Start date

Sep 17, 2025

Status verified

May 2026

Primary completion

Sep 17, 2029

Completion

Sep 17, 2029

Study Design

Enrollment

178 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Lior Braunstein, MD
  201-775-7446
  [email protected]
• Atif Khan, MD
  848-225-6334

Locations (7)

Find similar trials in Basking Ridge, NJ

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