3066 Participants Needed

Ovarian Suppression + Tamoxifen/Exemestane for Breast Cancer

(SOFT Trial)

Recruiting at 499 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: International Breast Cancer Study Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

GF

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

Patients must have completed baseline Quality of Life (QL) Forms prior to randomization
Patients must be accessible for follow-up
Patients must be informed of and agree to data and tissue material transfer and handling
See 9 more

Exclusion Criteria

My cancer has spread to distant parts of my body.
I have had cancer before, but it fits the exceptions.
I became postmenopausal after surgery or chemotherapy.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tamoxifen or exemestane with ovarian function suppression for 5 years

5 years
Monthly visits for injections, annual visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for 1 year, every 6 months for 5 years, then annually

Quality of Life Assessment

Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years

6 years

What Are the Treatments Tested in This Trial?

Interventions

  • Exemestane
  • Oophorectomy
  • Tamoxifen
  • Triptorelin
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: T+OFSExperimental Treatment6 Interventions
Group II: E+OFSExperimental Treatment6 Interventions
Group III: TamoxifenActive Control3 Interventions

Exemestane is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Aromasin for:
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Approved in United States as Aromasin for:
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Approved in Canada as Aromasin for:
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Approved in Japan as Aromasin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

International Breast Cancer Study Group

Lead Sponsor

Trials
29
Recruited
25,100+

ETOP IBCSG Partners Foundation

Lead Sponsor

Trials
66
Recruited
58,200+

SWOG Cancer Research Network

Collaborator

Trials
403
Recruited
267,000+

NSABP Foundation Inc

Collaborator

Trials
89
Recruited
140,000+

Breast International Group

Collaborator

Trials
34
Recruited
53,600+

Cancer and Leukemia Group B

Collaborator

Trials
81
Recruited
118,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

NCIC Clinical Trials Group

Collaborator

Trials
190
Recruited
145,000+

Southwest Oncology Group

Collaborator

Trials
389
Recruited
260,000+

North Central Cancer Treatment Group

Collaborator

Trials
49
Recruited
81,100+
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