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

• Status: Not yet recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Goserelin; Toremifene

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