Hormone Therapy +/− Everolimus for Breast Cancer

(e3 Trial)

Recruiting at1458 trial locations

Overseen by Mariana Chavez-MacGregor, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Southwest Oncology Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

Research Team

Mariana Chavez-MacGregor, MD, MSc

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for high-risk breast cancer patients who've had surgery with negative margins and appropriate axillary staging. They must have ER or PR positive status, not be on trastuzumab, have controlled diabetes if applicable, no uncontrolled lung disease, able to take oral meds, not pregnant/nursing, completed standard chemo prior to randomization, performance status 0-2 by Zubrod criteria. No recent heart attacks or severe cardiac disease.

Inclusion Criteria

I have more than one cancer spot in my breast, each far apart.

I have breast cancer in both breasts, diagnosed within a month of each other.

I have more than one cancer spot close to the biggest tumor in the same area of my breast.

Exclusion Criteria

My stomach and intestines work well and can absorb medication properly.

I do not have hepatitis.

I am not using, and will not use strong CYP3A4 inhibitors or inducers.

Treatment Details

Interventions

• Anastrozole (Hormone Therapy)
• Everolimus (mTOR inhibitor)
• Exemestane (Hormone Therapy)
• Goserelin Acetate (Hormone Therapy)
• Letrozole (Hormone Therapy)
• Leuprolide Acetate (Hormone Therapy)
• Tamoxifen Citrate (Hormone Therapy)

Trial Overview The study tests hormone therapy's effectiveness against breast cancer when given alone versus alongside everolimus. Hormone therapies include tamoxifen citrate and others that lower estrogen levels in the body. Everolimus may inhibit tumor growth by blocking enzymes needed for cell growth.

Participant Groups

Group I: Arm II Experimental Treatment 7 Interventions

Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.

Group II: Arm I Placebo Group 7 Interventions

Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or an aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo PO daily for 1 year 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?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

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