Hormone Therapy for Breast Cancer (TEXT Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: International Breast Cancer Study Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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

My breast cancer diagnosis was confirmed through tissue examination.

My cancer has not spread to distant parts of my body.

My cancer is only in my breast and nearby lymph nodes.

I do not have any detectable cancer in the lymph nodes under my arm.

I am a woman who has not gone through menopause.

I have had surgery to remove lymph nodes under my arm or a biopsy that was negative.

My cancer was entirely removed by surgery.

I have had surgery or radiation on the lymph nodes under my arm due to cancer.

My cancer is positive for estrogen or progesterone.

I have never had invasive breast cancer before.

Exclusion Criteria

My breast cancer cannot be removed by surgery and has spread to nearby areas.

I have not had chemotherapy before or after surgery.

I have had breast cancer in either the same or the opposite breast before.

I do not have liver disease that would interfere with long-term monitoring.

I am not taking any estrogen, progesterone, or androgen treatments.

I am not taking any other aromatase inhibitors.

I am not using any hormonal contraceptives.

I don't have any lung diseases that would interfere with long-term monitoring.

I am fertile and not using birth control methods that don't involve hormones.

I haven't had hormone therapy for breast cancer since diagnosis.

I have never had radiation therapy for ovarian cancer.

I haven't used tamoxifen, SERMs, or hormone therapy for over a year before my breast cancer diagnosis.

I am not currently on any oral or patch-based hormone treatments.

I have not had both of my ovaries removed.

I don't have heart disease that would interfere with long-term monitoring.

I have had a condition where my lymphocytes grow abnormally.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: E+OFSExperimental Treatment2 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+OFSActive Control2 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: