Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Ear… (NCT00090844) | Clinical Trial Compass
TerminatedPhase 2
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Stopped: Early closure due to low accrual
United States49 participantsStarted 2004-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.
PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer.
Who can participate
Age range
44 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Early-stage, operable disease
* Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer
* Hormone receptor status:
* Meets 1 of the following criteria:
* Estrogen receptor (ER)- OR progesterone receptor (PR)-positive
* ER- AND PR-negative
* No history of premature ovarian failure
PATIENT CHARACTERISTICS:
Age
* Under 45
Sex
* Female
Menopausal status
* Premenopausal
* Follicle-stimulating hormone levels \< 40 IU/L at baseline AND at least 2 menstrual periods within the past 6 months
* No first-degree relative menopausal at \< 40 years of age
Performance status
* Eastern Cooperative Oncology Group \[ECOG\] 0-1
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant or nursing
* Fertile patients must use effective non-hormonal methods of contraception
* No prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up
* No known allergies to gonadotrophin-releasing hormone agonists
* No other cancer except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No prior chemotherapy
Endocrine therapy
* At least 2 weeks since prior oral contraceptives
* No prior fertility treatment
* Clomiphene or pergonal for polycystic ovarian disease al…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Resumption of Menses
Timeframe: Baseline, end of chemotherapy then 5 years