Study on Adding Surgery and Radiation to Standard Treatment for HER2-Positive Breast Cancer That Has Spread

Sponsor: SWOG Cancer Research Network

Sponsor score: 0

ClinicalTrials ID:NCT07578116

This clinical trial is exploring whether adding surgery and radiation to the usual drug treatment can improve outcomes for patients with HER2-positive breast cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is investigating if combining surgery and radiation with the standard drug treatment can help patients with HER2-positive stage IV breast cancer live longer or delay cancer progression. The standard treatment involves drugs that target HER2, a protein that promotes cancer growth. These drugs travel throughout the body to treat cancer in the breast and other areas it has spread to. Surgery and radiation focus on specific areas to remove or shrink tumors. The study aims to see if this combined approach is more effective than drug treatment alone.

Description

The main goal of this study is to compare the survival rates of patients with HER2-positive breast cancer that has spread to a few areas (oligometastatic) when they receive a combination of surgery, radiation, and standard drug treatment versus drug treatment alone. The study will also look at how long patients live without their cancer getting worse.

Participants will first receive standard HER2-targeted drug treatment for 12 to 24 weeks. Those who respond well will be divided into two groups. One group will continue with drug treatment alone, while the other group will also receive surgery and radiation to target the cancer more directly.

The study will monitor the effectiveness of these treatments by checking how long patients live without cancer progression and their overall survival rates. Researchers will also collect tissue and blood samples for future studies.

Participants will undergo various tests, including heart scans, MRIs, mammograms, and CT scans, throughout the trial. After completing the study treatment, participants will be followed up for 10 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have HER2-positive breast cancer that has spread to 1 to 5 distant areas (oligometastatic).
  • Be 18 years or older.
  • Have not received whole brain radiation.
  • Be able to safely receive standard HER2-targeted drug treatment.
  • Be candidates for surgery and radiation to treat the cancer.
  • Agree to participate in specimen banking for future research.
  • Understand the study and sign informed consent.

For Step 2:

  • Have completed 12-24 weeks of initial drug treatment.
  • Show partial or complete response in the breast or stable disease in metastatic sites.
  • Be eligible for surgery and radiation to treat the cancer.
  • Have no metastatic lesions that cannot be treated with radiation.

Locations

FACILITYZIPCITYSTATE
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro72401JonesboroArkansas
Smilow Cancer Hospital-Derby Care Center06418DerbyConnecticut
Smilow Cancer Hospital Care Center-Fairfield06824FairfieldConnecticut
Smilow Cancer Hospital Care Center at Greenwich06830GreenwichConnecticut
Smilow Cancer Hospital Care Center - Guilford06437GuilfordConnecticut
Smilow Cancer Hospital-Hamden Care Center06518HamdenConnecticut
Smilow Cancer Center/Yale-New Haven Hospital06510New HavenConnecticut
Yale University06520New HavenConnecticut
Yale-New Haven Hospital North Haven Medical Center06473North HavenConnecticut
Smilow Cancer Hospital Care Center at Long Ridge06902StamfordConnecticut

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