Aggressive Local Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByEric A. Strom

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to find out if adding local therapy (surgery and/or radiation) to standard therapy (chemotherapy or endocrine therapy) in the treatment of patients with metastatic breast cancer can help to control the disease for a longer period of time than standard therapy alone.

Eligibility Criteria

This trial is for breast cancer patients with 1 to 3 bone-only metastatic sites, good physical functioning (KPS >=70), and normal organ function tests. It's open to those who've had prior chemotherapy but not for those with a risk of fracture needing immediate local therapy, other cancers within the last 3 years, or untreated central nervous system disorders.

Inclusion Criteria

My breast cancer has spread only to my bones.

Your white blood cell count and platelet count are within a certain range.

I may receive treatment for a high risk of fractures before starting systemic therapy.

+7 more

Exclusion Criteria

I have been cancer-free from a second type of cancer, except skin cancer, for less than 3 years.

I am a woman who has not had a period for less than 12 months and will take a pregnancy test before joining the study.

Central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant to preclude informed consent or interfere with complying with protocol treatments

+6 more

Participant Groups

Researchers are testing if adding local treatments like surgery or radiation to standard therapies such as chemotherapy or endocrine therapy can extend the time without disease progression in patients with limited bone-only metastasis from breast cancer.

1Treatment groups

Experimental Treatment

Group I: Standard Therapy + Local TherapyExperimental Treatment2 Interventions

Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation)