Hormone Therapy for Breast Cancer

(TEXT Trial)

Recruiting at 227 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: International Breast Cancer Study Group

Must be taking: Triptorelin, Exemestane, Tamoxifen

Must not be taking: Hormonal therapy, Chemotherapy

Disqualifiers: Pregnancy, Noncompliance, Other malignancy, 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

2672 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

Research Team

Barbara Walley, MD, FRCPC

Principal Investigator

Tom Baker Cancer Centre

Olivia Pagani, MD

Principal Investigator

Oncology Institute of Southern Switzerland

Eligibility Criteria

This trial is for premenopausal women with hormone-responsive breast cancer that's been surgically removed and isn't widespread. Participants must not be pregnant, should use nonhormonal birth control, and have no history of other cancers or serious diseases in the last 5 years. They can't be on hormonal treatments or have had prior chemotherapy for breast cancer.

Inclusion Criteria

I haven't had any cancer except certain skin cancers or non-spreading breast cancer in the last 5 years.

My estrogen levels are considered premenopausal after surgery.

My breast cancer diagnosis was confirmed through tissue examination.

Exclusion Criteria

No history of noncompliance to medical regimens

I don't have any chronic diseases that would interfere with long-term treatment.

I haven't had any cancer except for skin cancer in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ovarian function suppression by triptorelin and either exemestane or tamoxifen for 5 years

5 years

Monthly visits for injections

Follow-up

Participants are monitored for disease-free survival and overall survival

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 annually for 3 years

5 years

Treatment Details

Interventions

• Exemestane
• Tamoxifen
• Triptorelin

Trial Overview The study compares two hormone-blocking treatments: triptorelin with exemestane versus triptorelin with tamoxifen. It aims to find out which combination is more effective at preventing the growth of breast cancer cells by blocking estrogen.

Participant Groups

Group I: E+OFS Experimental Treatment 2 Interventions

Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

Group II: T+OFS Active Control 2 Interventions

Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Breast International Group

Collaborator

Trials

34

Recruited

53,600+