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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-year estimates, reported at a median follow-up of 9 years
Awards & highlights
TEXT 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.Check my eligibility
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.See study design
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.
TEXT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My cancer is positive for estrogen or progesterone.
Select...
I have never had invasive breast cancer before.
TEXT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free Survival
Secondary outcome measures
Breast Cancer-free Interval
Distant Recurrence-free Interval
Overall Survival
TEXT 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
Find a Location
Who is running the clinical trial?
International Breast Cancer Study GroupLead Sponsor
28 Previous Clinical Trials
22,446 Total Patients Enrolled
21 Trials studying Breast Cancer
17,971 Patients Enrolled for Breast Cancer
ETOP IBCSG Partners FoundationLead Sponsor
65 Previous Clinical Trials
55,391 Total Patients Enrolled
29 Trials studying Breast Cancer
41,644 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,930,481 Total Patients Enrolled
939 Trials studying Breast Cancer
1,540,688 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My breast cancer cannot be removed by surgery and has spread to nearby areas.I have not had chemotherapy before or after surgery.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.I have never had a blood clot or if I did, my doctor says it's okay.My breast cancer diagnosis was confirmed through tissue examination.My cancer has not spread to distant parts of my body.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 do not have kidney 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 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 am not currently taking bisphosphonates, or I meet the specific criteria for their use.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 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.I am not using any hormonal contraceptives.My cancer is only in my breast and nearby lymph nodes.My cancer was entirely removed by surgery.I don't have heart disease that would interfere with long-term monitoring.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 had a condition where my lymphocytes grow abnormally.I have never had invasive breast cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: T+OFS
- Group 2: E+OFS
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project allow for people who are over the age of 55 to participate?
"Patients who meet the age requirements of 18-65 are eligible for this particular study. Out of the 2731 studies for patients over 65, this trial is 91."
Answered by AI
How do I qualify for this clinical research program?
"This study is looking for 2672 breast cancer patients that meet the following criteria: 18-65 years old, have had a breast-conserving procedure (lumpectomy, quadrantectomy, or partial mastectomy) with negative margins for invasive disease and ductal carcinoma in situ, or have had a total mastectomy. Patients must also have completely resected disease, and either negative or positive sentinel nodes."
Answered by AI
What is the most popular therapeutic use for exemestane?
"While often used to treat breast cancer, exemestane can also target other conditions like estrogen receptors, therapeutic procedure, and malignant neoplasms."
Answered by AI
Are there different sites located throughout the state that are conducting this research?
"To make things more convenient for those that choose to participate, the team behind this trial has set up 100 sites. If you live near Saint Paul, Lawrence or Sioux City, there is likely a site near you. However, there are also other locations across the country."
Answered by AI
Is this the first time exemestane has been trialed?
"The first clinical trial for exemestane was in 1994 at Queen Mary University of London. As of now, there are a total of 336 completed trials. There are presently 180 live trials, with many of these studies running out of Saint Paul, Minnesota."
Answered by AI
Does the FDA recognize exemestane as a legitimate medication?
"There is both pre-existing data supporting exemestane's efficacy and multiple rounds of clinical data affirming its safety, so it received a score of 3."
Answered by AI
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