Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Peking Union Medical College Hospital

Current Primary Outcome:

  • Disease free survival [ Time Frame: up to 120 months ]
  • Overall Survival [ Time Frame: up to 120 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: up to 120 months ]
  • Bone mineral density loss [ Time Frame: up to 120 months ]
    measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers
  • Hormone levels [ Time Frame: up to 120 months ]
  • Incidence of pregnancy [ Time Frame: up to 120 months ]


Original Secondary Outcome: Same as current

Information By: Peking Union Medical College Hospital

Dates:
Date Received: May 5, 2014
Date Started: May 2014
Date Completion:
Last Updated: June 2, 2014
Last Verified: June 2014