Hormone Therapy + Chemotherapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1742 other locations

Overseen by Kevin M Kalinsky

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.

Research Team

Kevin M Kalinsky

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for women aged 18+ who've had breast surgery and need radiation or mastectomy, with a performance status of 0-2. They must be able to receive certain chemotherapies, have node-positive invasive breast cancer that's estrogen/progesterone receptor positive and HER-2 negative. No recent other cancers (except some skin/cervical cancers) or chronic steroid/immunosuppressant use.

Inclusion Criteria

My breast cancer is hormone receptor positive, HER2 negative, and has spread to 1-3 lymph nodes.

I had surgery for breast cancer and will have or had radiation.

I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

I am not on long-term steroids or drugs that weaken my immune system.

I have not started any chemotherapy or hormone therapy for my breast cancer.

I do not have inflammatory breast cancer or cancer that has spread.

Treatment Details

Interventions

• Anastrozole (Hormone Therapy)
• Exemestane (Hormone Therapy)
• Letrozole (Hormone Therapy)
• Systemic Chemotherapy (Chemotherapy)
• Tamoxifen Citrate (Hormone Therapy)

Trial Overview The study compares the effectiveness of hormone therapies (tamoxifen citrate, anastrozole, letrozole, exemestane) alone versus combined with chemotherapy in treating invasive breast cancer. It aims to see which combination better stops tumor growth by blocking estrogen or killing/dividing cells.

Participant Groups

Group I: Arm II (endocrine therapy) Experimental Treatment 6 Interventions

Patients receive a protocol-approved endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (chemotherapy and endocrine therapy) Experimental Treatment 7 Interventions

Patients receive a protocol-approved chemotherapy regimen based on the patient and/or physician preference. Patients then receive a protocol-approved adjuvant endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.

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?

National Cancer Institute (NCI)

Lead Sponsor

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