Ovarian Suppression + Tamoxifen/Exemestane for Breast Cancer

(SOFT Trial)

Recruiting at499 trial locations

Overseen by Gini Fleming

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: International Breast Cancer Study Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer. PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

Research Team

Gini Fleming

Principal Investigator

ETOP IBCSG Partners Foundation

Eligibility Criteria

This trial is for premenopausal women who have had surgery for hormone-responsive breast cancer. They must be within 8 months post-chemotherapy, with no prior invasive breast cancer or current metastatic disease. Participants need to agree to data and tissue handling guidelines and complete quality of life forms if required by the study group.

Inclusion Criteria

Patients must have completed baseline Quality of Life (QL) Forms prior to randomization

Patients must be accessible for follow-up

Patients must be informed of and agree to data and tissue material transfer and handling

Exclusion Criteria

My cancer has spread to distant parts of my body.

I have had cancer before, but it fits the exceptions.

I became postmenopausal after surgery or chemotherapy.

Treatment Details

Interventions

• Exemestane (Hormone Therapy)
• Oophorectomy (Procedure)
• Tamoxifen (Hormone Therapy)
• Triptorelin (Hormone Therapy)

Trial Overview The trial tests ovarian suppression using tamoxifen alone versus in combination with exemestane or triptorelin, aiming to reduce estrogen production that can stimulate tumor growth. It's a phase III randomized study comparing these treatments' effectiveness in preventing breast cancer recurrence.

Participant Groups

Group I: T+OFS Experimental Treatment 6 Interventions

Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

Group II: E+OFS Experimental Treatment 6 Interventions

Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

Group III: Tamoxifen Active Control 3 Interventions

Tamoxifen 20mg orally daily for 5 years

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

Approved in Canada as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Japan as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Who Is Running the Clinical Trial?

International Breast Cancer Study Group

Lead Sponsor

Trials

29

Recruited

25,100+

ETOP IBCSG Partners Foundation

Lead Sponsor

Trials

66

Recruited

58,200+

Rolf A. Stahel

ETOP IBCSG Partners Foundation

Chief Executive Officer since 2020

MD from University of Zürich

Solange Peters

ETOP IBCSG Partners Foundation

Chief Medical Officer since 2023

MD and PhD from University Hospital of Lausanne

SWOG Cancer Research Network

Collaborator

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

NSABP Foundation Inc

Collaborator

Trials

89

Recruited

140,000+

Priya Rastogi

NSABP Foundation Inc

Chief Executive Officer since 2022

MD from University of Pittsburgh

Charles E. Geyer Jr.

NSABP Foundation Inc

Chief Medical Officer since 2022

MD from Texas Tech University

Breast International Group

Collaborator

Trials

34

Recruited

53,600+

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

Dr. Richard L. Schilsky

Cancer and Leukemia Group B

Chief Executive Officer since 2012

MD from University of Chicago

Dr. Walter Stadler

Cancer and Leukemia Group B

Chief Medical Officer since 2012

MD from Harvard Medical School

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

NCIC Clinical Trials Group

Collaborator

Trials

190

Recruited

145,000+

Dr. Lesley Seymour

NCIC Clinical Trials Group

Chief Medical Officer since 2014

MD from University of Toronto

Dr. Janet Dancey

NCIC Clinical Trials Group

Chief Executive Officer since 2014

MD from Queen's University

Southwest Oncology Group

Collaborator

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

North Central Cancer Treatment Group

Collaborator

Trials

49

Recruited

81,100+