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

Must not be taking: GnRH analogues, SERMs, HRT

Disqualifiers: Postmenopausal, Metastatic disease, Inoperable cancer, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 5 years

3066 Participants Needed

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?

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

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.

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?

Group I: T+OFS Experimental Treatment 6 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+OFS Experimental Treatment 6 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: Tamoxifen Active Control 3 Interventions

Tamoxifen 20mg orally daily for 5 years

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

Approved in European Union as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in United States as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Canada as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Japan as Aromasin for:

• Early breast cancer
• Advanced breast cancer

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+