Breast Cancer Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | up to 120 months | No | |
Primary | Overall Survival | up to 120 months | No | |
Secondary | Quality of life | up to 120 months | No | |
Secondary | Bone mineral density loss | measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers | up to 120 months | No |
Secondary | Hormone levels | up to 120 months | No | |
Secondary | Incidence of pregnancy | up to 120 months | No |
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