A Phase 2 Study of Surgery and Radiotherapy Plus Standard Treatment in People With Breast Cancer That Spread to a Few Sites

Full 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)]

Purpose

This study is assessing a new treatment approach for people with oligometastatic breast cancer. This means their cancer has spread to a small number of other parts of the body. Their cancers have high levels of the HER2 protein, which promotes breast cancer growth. In addition, they started drug therapy for their cancer and it has not gotten worse in the last 3-12 months.

The usual approach for this type of cancer is hormonal therapy, targeted medications, or chemotherapy. Researchers want to learn if surgery plus radiation therapy and the usual approach works better than the usual approach alone.

If you take part in this study, you will be randomly assigned to one of these treatments groups:

  • The usual approach (drug therapy).
  • The usual approach plus surgery (lumpectomy or mastectomy) and radiation therapy.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have HER2-positive oligometastatic breast cancer (5 or fewer tumors, none of which are in the brain).
  • Have been receiving drug therapy and not experienced worsening of the cancer in the last 3-12 months.
  • Not have serious side effects from prior treatments.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Lior Braunstein’s office at 201-775-7446.

Protocol

25-145

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Diseases

ClinicalTrials.gov ID

NCT07053085