RECRUITING

A Study of Surgery and Radiotherapy in People With Breast Cancer

Conditions

Metastatic Breast Cancer HER2-positive Breast Cancer Consolidative surgery Radiotherapy Ablation Resection 25-145

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)]

Quick Facts

Study Start:2025-09-17

Study Completion:2029-09-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07053085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Lior Braunstein, MD

CONTACT

201-775-7446

braunstl@mskcc.org

Atif Khan, MD

CONTACT

848-225-6334

Principal Investigator

Lior Braunstein, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Lior Braunstein, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-17

Study Completion Date2029-09-17

Study Record Updates

Study Start Date2025-09-17

Study Completion Date2029-09-17

Terms related to this study

Keywords Provided by Researchers

Consolidative surgery
Radiotherapy
Ablation
Resection
25-145

Additional Relevant MeSH Terms

Metastatic Breast Cancer
HER2-positive Breast Cancer