Ovarian Suppression + Tamoxifen/Exemestane for Breast Cancer
(SOFT Trial)
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Gini Fleming
Principal Investigator
ETOP IBCSG Partners Foundation
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tamoxifen or exemestane with ovarian function suppression for 5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Quality of Life Assessment
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years
What Are the Treatments Tested in This Trial?
Interventions
- Exemestane
- Oophorectomy
- Tamoxifen
- Triptorelin
Exemestane is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
International Breast Cancer Study Group
Lead Sponsor
ETOP IBCSG Partners Foundation
Lead Sponsor
SWOG Cancer Research Network
Collaborator
NSABP Foundation Inc
Collaborator
Breast International Group
Collaborator
Cancer and Leukemia Group B
Collaborator
National Cancer Institute (NCI)
Collaborator
NCIC Clinical Trials Group
Collaborator
Southwest Oncology Group
Collaborator
North Central Cancer Treatment Group
Collaborator