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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

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 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.

SOFT Trial 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

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

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkNETWORK

394 Previous Clinical Trials

262,104 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

54,997 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

Annals of OncologyJournal

Concurrent and Sequential Initiation of Ovarian Function Suppression with Chemotherapy in Premenopausal Women with Endocrine-responsive Early Breast Cancer: An Exploratory Analysis of TEXT and SOFT

Regan, M.M., B.A. Walley, P.A. Francis, G.F. Fleming, I. Láng, H.L. Gómez, M. Colleoni, et al.. 2017. “Concurrent and Sequential Initiation of Ovarian Function Suppression with Chemotherapy in Premenopausal Women with Endocrine-responsive Early Breast Cancer: An Exploratory Analysis of TEXT and SOFT”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdx285.

Journal of Clinical OncologyJournal

Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women with Early Breast Cancer: Patient-reported Outcomes in the Suppression of Ovarian Function Trial

Ribi, Karin, Weixiu Luo, Jürg Bernhard, Prudence A. Francis, Harold J. Burstein, Eva Ciruelos, Meritxell Bellet, et al.. 2016. “Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women with Early Breast Cancer: Patient-reported Outcomes in the Suppression of Ovarian Function Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.64.8675.

New England Journal of MedicineJournal

Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer

Pagani, Olivia, Meredith M. Regan, Barbara A. Walley, Gini F. Fleming, Marco Colleoni, István Láng, Henry L. Gomez, et al.. 2014. “Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1404037.

New England Journal of MedicineJournal