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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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