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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

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-year estimates, reported at a median follow-up of 8 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free Survival

Secondary study objectives

Breast Cancer-free Interval

Distant Recurrence-free Interval

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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