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Hormone Therapy

Ovarian Suppression + Tamoxifen/Exemestane for Breast Cancer (SOFT Trial)

Phase 3
Waitlist Available
Led By Gini Fleming
Research Sponsored by International Breast Cancer Study Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven, resected breast cancer with hormone receptor positive tumors
Premenopausal women with estradiol (E2) in the premenopausal range
Must not have
Patients with distant metastatic disease
Patients who are postmenopausal after surgery or after chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-year estimates, reported at a median follow-up of 8 years
Awards & highlights

Summary

This trial is testing whether suppressing ovarian function and combining it with either tamoxifen or exemestane is more effective than tamoxifen alone in treating premenopausal women with hormone-responsive breast cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include menopause-like symptoms (hot flashes, vaginal dryness), joint pain from exemestane, mood changes, decreased libido due to hormonal alterations, and potential risks associated with oophorectomy like surgical complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer was confirmed by a biopsy and is hormone receptor positive.
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My estrogen levels are in the premenopausal range.
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My cancer is only in my breast and nearby lymph nodes, with no spread elsewhere.
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I had surgery for breast cancer and no remaining signs of cancer in the area.
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I have had surgery to remove lymph nodes or a biopsy showing no cancer in them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to distant parts of my body.
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I became postmenopausal after surgery or chemotherapy.
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I have noticeable cancer remaining in my underarm area.
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I have had breast cancer before, either in the same or the other breast.
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I have had surgery to remove both ovaries or radiation treatment on my ovaries.
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I am not pregnant or breastfeeding and do not plan to become pregnant in the next 5 years.
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I have received hormone therapy for breast cancer before being considered for this trial.
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My breast cancer cannot be removed with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-year estimates, reported at a median follow-up of 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-year estimates, reported at a median follow-up of 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free Survival
Secondary outcome measures
Breast Cancer-free Interval
Distant Recurrence-free Interval
Overall Survival

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: T+OFSExperimental Treatment6 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+OFSExperimental Treatment6 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: TamoxifenActive Control3 Interventions
Tamoxifen 20mg orally daily for 5 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exemestane
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Tamoxifen
FDA approved
Triptorelin
FDA approved

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkNETWORK
395 Previous Clinical Trials
262,082 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
International Breast Cancer Study GroupLead Sponsor
28 Previous Clinical Trials
22,052 Total Patients Enrolled
22 Trials studying Breast Cancer
20,643 Patients Enrolled for Breast Cancer
ETOP IBCSG Partners FoundationLead Sponsor
65 Previous Clinical Trials
55,078 Total Patients Enrolled
30 Trials studying Breast Cancer
44,316 Patients Enrolled for Breast Cancer
~142 spots leftby Jul 2025
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