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

Conditions: Breast Cancer; Chemotherapy Induced Amenorrhea; Ovarian Function Suppression

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.

this is a single center, randomized, controlled study. patients undergo surgical resection with standard doxorubicin/cyclophosphamide followed by docetaxel (ac-t). chemotherapy begins within 4 weeks after surgery for patients randomized to arm i-iv. arm i: patients who didn't have cia receive oral toremifene daily. treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. arm ii: patients who had cia receive toremifene as in arm i. arm iii: patients without cia receive oral toremifene and goserelin for ovarian function suppression. arm iv: patients with cia receive oral toremifene and goserelin for ovarian function suppression. patients are followed every 6 months for 5 years and annually thereafter.

Eligibility criteria:
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

Keywords: breast cancer chemotherapy induced amenorrhea goserelin