Fulvestrant + Anastrozole for Breast Cancer

Recruiting in Palo Alto (17 mi)

+866 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study is being conducted to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body.

Research Team

Cynthia Ma, MD, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Postmenopausal women with Stage II-III estrogen receptor positive breast cancer, who have not started any treatment and are planning to undergo surgery. Participants must be at least 18 years old, have a specific score indicating the presence of estrogen receptors in their tumor cells, and meet certain health criteria based on blood tests and physical exams.

Inclusion Criteria

I am able to care for myself and perform daily activities.

My breast cancer is estrogen receptor positive with a high Allred score or high ER positivity.

Your recent lab test results need to meet certain standards.

Exclusion Criteria

I have not gone through menopause.

My breast cancer involves redness of the breast or skin invasion.

I have had a surgical biopsy for my breast cancer.

Treatment Details

Interventions

• Anastrozole (Hormone Therapy)
• Fulvestrant (Hormone Therapy)

Trial Overview The trial is testing whether taking fulvestrant alone or combined with anastrozole before surgery is more effective than just anastrozole for shrinking tumors. Anastrozole lowers estrogen to inhibit tumor growth and is standard care pre-surgery; fulvestrant decreases estrogen receptors in tumor cells but isn't approved for early-stage use yet.

Participant Groups

Group I: Arm III (anastrozole and fulvestrant) Active Control 2 Interventions

Patients receive anastrozole daily in combination with fulvestrant on days 1 and 15 of cycle 1, and on day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Group II: Arm I (anastrozole) Active Control 1 Intervention

Patients receive anastrozole daily for 6 cycles followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Group III: Arm II (fulvestrant) Active Control 1 Intervention

Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Anastrozole is already approved in Canada, Japan for the following indications:

Approved in Canada as Arimidex for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

Approved in Japan as Arimidex for:

• Breast cancer

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School