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Hormone Therapy

Hormone Therapy for Breast Cancer (TEXT Trial)

Phase 3

Waitlist Available

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 confirmed breast cancer

No distant metastases

Must not have

Locally advanced inoperable breast cancer including inflammatory breast cancer, supraclavicular node involvement, and enlarged internal mammary nodes

No prior neoadjuvant or adjuvant chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-year estimates, reported at a median follow-up of 9 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two hormone therapies to see which is more effective in treating premenopausal women with hormone responsive breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Triptorelin may cause menopause-like symptoms, exemestane might lead to joint pain or hot flashes, and tamoxifen could increase risk of blood clots and uterine changes. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer diagnosis was confirmed through tissue examination.

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

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

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

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I am a woman who has not gone through menopause.

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

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My cancer was entirely removed by surgery.

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

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My cancer is positive for estrogen or progesterone.

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I have never had invasive breast cancer before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have not had chemotherapy before or after surgery.

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

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

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

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I am not taking any other aromatase inhibitors.

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I am not using any hormonal contraceptives.

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

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

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

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I have never had radiation therapy for ovarian cancer.

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

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

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I have not had both of my ovaries removed.

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

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I have had a condition where my lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-year estimates, reported at a median follow-up of 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-year estimates, reported at a median follow-up of 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-year estimates, reported at a median follow-up of 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free Survival

Secondary study objectives

Breast Cancer-free Interval

Distant Recurrence-free Interval

Overall Survival

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exemestane

FDA approved

Gonadorelin

FDA approved

0 / 26Eligibility criteria met