Adjuvant Toremifene With or Without Goserrelin in Premenopausal Women With Stage I-IIIA, Hormonal… (NCT02132390) | Clinical Trial Compass
UnknownPhase 3
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
China300 participantsStarted 2014-05
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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 (pri…