Clinical trial · Interventional
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements. The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.
Conditions
Conditions (2)
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 |
| Ovarian Function | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goserelin acetate | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A
- description
- Patients receiving only adjuvant chemotherapy
- type
- EXPERIMENTAL
- label
- B
- description
- Patient receiving goserelin acetate along with adjuvant chemotherapy
- interventionNames
- Drug: Goserelin acetate
Primary outcomes (2)
- measure
- The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)
- timeFrame
- Each 3 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed invasive breast carcinoma * Candidates for adjuvant chemotherapy for primary breast cancer * Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels Exclusion Criteria: * Previous systemic chemotherapy * Pregnancy * Stage IV breast cancer
References
Publications (11)
- BACKGROUNDAtaya K, Rao LV, Lawrence E, Kimmel R. Luteinizing hormone-releasing hormone agonist inhibits cyclophosphamide-induced ovarian follicular depletion in rhesus monkeys. Biol Reprod. 1995 Feb;52(2):365-72. doi: 10.1095/biolreprod52.2.365. PMID 7711205
- BACKGROUNDAtaya KM, McKanna JA, Weintraub AM, Clark MR, LeMaire WJ. A luteinizing hormone-releasing hormone agonist for the prevention of chemotherapy-induced ovarian follicular loss in rats. Cancer Res. 1985 Aug;45(8):3651-6. PMID 3926307
- BACKGROUNDBines J, Oleske DM, Cobleigh MA. Ovarian function in premenopausal women treated with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1996 May;14(5):1718-29. doi: 10.1200/JCO.1996.14.5.1718. PMID 8622093
- BACKGROUNDBlumenfeld Z, Eckman A. Preservation of fertility and ovarian function and minimization of chemotherapy-induced gonadotoxicity in young women by GnRH-a. J Natl Cancer Inst Monogr. 2005;(34):40-3. doi: 10.1093/jncimonographs/lgi015. PMID 15784821
- BACKGROUNDBokser L, Szende B, Schally AV. Protective effects of D-Trp6-luteinising hormone-releasing hormone microcapsules against cyclophosphamide-induced gonadotoxicity in female rats. Br J Cancer. 1990 Jun;61(6):861-5. doi: 10.1038/bjc.1990.192. PMID 2142603
- BACKGROUNDBrincker H, Rose C, Rank F, Mouridsen HT, Jakobsen A, Dombernowsky P, Panduro J, Andersen KW. Evidence of a castration-mediated effect of adjuvant cytotoxic chemotherapy in premenopausal breast cancer. J Clin Oncol. 1987 Nov;5(11):1771-8. doi: 10.1200/JCO.1987.5.11.1771. PMID 3316514
- BACKGROUNDCheer SM, Plosker GL, Simpson D, Wagstaff AJ. Goserelin: a review of its use in the treatment of early breast cancer in premenopausal and perimenopausal women. Drugs. 2005;65(18):2639-55. doi: 10.2165/00003495-200565180-00011.