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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
The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere
Patients must have had proper surgery for primary breast cancer with no known clinical residual loco-regional disease
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

SOFT 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.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.

SOFT Trial Eligibility Criteria

Inclusion Criteria

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

SOFT Trial 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

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.

SOFT 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
394 Previous Clinical Trials
262,544 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
64 Previous Clinical Trials
55,027 Total Patients Enrolled
30 Trials studying Breast Cancer
44,316 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the Quality-of-Life Assessment have any negative side effects for patients?

"There is both prior clinical data and multiple rounds of supportive data, so Quality-of-Life Assessment receives a score of 3 for safety."

Answered by AI

Are there many test locations for this experiment within the US?

"This study has 3 primary locations in Brigham and Women's Hospital, University of New mexico Cancer Center, and Bay Area Medical Center. There are also 100 other sites participating."

Answered by AI

Could you explain the requirements for joining this clinical trial?

"This medical trial is looking for 3066 participants that have malignant neoplasms and meet the following requirements: they must be between 18-65 years old, have completed baseline Quality of Life (QL) Forms prior to randomization (unless they are cognitively or physically impaired, which would interfere with their ability to fill out the forms, or unable to read any of the languages available on IBCSG QL forms), have undergone a total mastectomy or breast-conserving procedure (lumpectomy, quadrantectomy or partial mastectomy with margins clear of invasive cancer and ductal breast carcinoma in situ [DC"

Answered by AI

Could you elaborate on how this research builds off of other Quality-of-Life Assessment studies?

"There are 182 active clinical trials studying Quality-of-Life Assessment with 62 trials in Phase 3. While the majority of the clinical trials for Quality-of-Life Assessment are based in Pisa, PI, there are 12050 locations operating studies for Quality-of-Life Assessment."

Answered by AI

Are there any available positions in this clinical trial for new participants?

"There are no open enrollments for this specific trial at the moment. This study was first posted on December 17th, 2003 with its most recent update happening on November 15th, 2020. However, if you are still interested in participating in clinical trials, there are 2370 trials for patients with malignant neoplasms and 182 Quality-of-Life Assessment studies that are actively looking for participants."

Answered by AI

Does this research opportunity extend to elderly individuals?

"The age range for patients that are eligible for this study is 18 to 65 years old."

Answered by AI

What ailments does the Quality-of-Life Assessment usually address?

"Quality-of-Life Assessment is an effective tool for managing different medical conditions, such as estrogen receptors, kidney failure, and acute procedures."

Answered by AI

Are there any limits on the amount of patients who can be in this trial?

"This research is not currently enrolling patients. The study was first advertised on December 17th, 2003 and has most recently been updated on November 15th, 2022. However, there are 2370 other trials actively recruiting for patients with malignant neoplasms and 182 Quality-of-Life Assessment studies that participants can sign up for."

Answered by AI
Recent research and studies
~145 spots leftby Feb 2025