Clinical trial · Interventional
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
Preservation of Ovarian Function in Young Women Treated With (Neo) Adjuvant Chemotherapy for Breast Cancer: A Randomized Trial Using the Gonadotropin-releasing Hormone (GnRH) Agonist (Triptorelin) During Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early closure due to low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Drug Toxicity | — | UNRESOLVED | — |
| Hormone Changes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- triptorelin
- description
- GnRH analogue (triptorelin) during chemotherapy
- interventionNames
- Drug: triptorelin
- type
- NO_INTERVENTION
- label
- no triptorelin
- description
- No GnRH analogue (triptorelin) during chemotherapy
Primary outcomes (1)
- measure
- Time to Resumption of Menses
- timeFrame
- Baseline, end of chemotherapy then 5 years
- description
- Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 44 Years
Show eligibility criteria text
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 allowed
* No other concurrent oral or transdermal hormonal therapy, including any of the following:
* Estrogen
* Progesterone
* Androgens
* Aromatase inhibitors
* Hormone replacement therapy
* Oral contraceptives
Radiotherapy
* No prior ovarian radiotherapy
Surgery
* No prior bilateral oophorectomy
* No plans for oophorectomy or hysterectomy within the next 2 years
Other
* At least 1 week since prior warfarin
Exclusion Criteria:
* History of premature ovarian failure
* Over 45 years of age
* First-degree relative menopausal at \< 40 years of age
* Pregnant or nursing
* Prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up
* Known allergies to gonadotrophin-releasing hormone agonists
* Other cancer besides nonmelanoma skin cancer
* Prior chemotherapy
* Prior ovarian radiotherapy
* Prior bilateral oophorectomyReferences
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