Clinical trial · Interventional
Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea
Study of Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal Receptor Positive Breast Cancer Accompanied With or Without Chemotherapy Induced Amenorrhoea
NCT02132390CI-TRIAL-00014779unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Compare the potential benefits of adjuvant toremifene with or without goserelin in premenopausal women with stage I-IIIA, hormonal receptor positive breast cancer accompanied with or without chemotherapy induced amenorrhoea.
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 |
| Chemotherapy Induced Amenorrhea | — | UNRESOLVED | — |
| Ovarian Function Suppression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goserelin | Drug | Goserelin | ALIAS |
| Toremifene | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity
- interventionNames
- Drug: Toremifene
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients who had CIA receive toremifene as in arm I
- interventionNames
- Drug: Toremifene
- type
- EXPERIMENTAL
- label
- Arm III
- description
- Patients without CIA receive oral toremifene and goserelin for ovarian function suppression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures * Age of at least 18 and at most 45 years * Spontaneous and regular menstrual periods before study entry with FSH below 15 mlU/ml in follicular phase * Histologically confirmed primary breast cancer with the need for anthracycline-based chemotherapy * Steroid receptor (estrogen and progesterone) positive tumor (diagnosis according to hospital standard-procedures) * No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated * Karnofsky-Index \>80% * Life expectancy of at least 10 years, disregarding the diagnosis of cancer * Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution * Patients underwent standard Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-T) * Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center. Exclusion Criteria: * Known hypersensitivity reaction to the investigational compounds or incorporated substances * Prior cytotoxic treatment for any reason * Suspected (primary or secondary) ovarian insufficiency * Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration and must implement adequate non-hormonal contraceptive measures during study treatment; prior use of hormonal contraceptives has to be discontinued before first Goserelin injection * Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study * Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) * Concurrent treatment with other experimental drugs or any other anti-cancer therapy * Concurrent treatment with sex hormones. Prior treatment must be stopped before study entry
References
Publications (0)
Data not yet available
No reference posted for this study.