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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Disease free survival
Time frame: up to 120 months
Overall Survival
Time frame: up to 120 months
Quality of life
Time frame: up to 120 months
Bone mineral density loss
measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers
Time frame: up to 120 months
Hormone levels
Time frame: up to 120 months
Incidence of pregnancy
Time frame: up to 120 months
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