Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Amenorrhea

Breast Diseases

Skin Diseases

Menstruation Disturbances

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Goserelin

Toremifene

Antineoplastic Agents, Hormonal

Estrogens

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Hormones

Hormone Antagonists

Patients who didn't have CIA receive oral toremifene daily. Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity

Patients who had CIA receive toremifene as in arm I

Patients without CIA receive oral toremifene and goserelin for ovarian function suppression

Patients with CIA receive oral toremifene and goserelin for ovarian function suppression.

Yidong ZHOU, Master

Changjun WANG, Doctor

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.

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 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

measured by dual energy X-ray absorptiometry scans at every 12 months and by serum biomarkers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT02132390	Breast Cancer Chemotherapy In... Ovarian Functio...	Goserelin Toremifene	18 Years - 45 Years	Peking Union Medical College Hospital
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	NCT02132390	Breast Cancer Chemotherapy In... Ovarian Functio...	Goserelin Toremifene	18 Years - 45 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for chemotherapy induced amenorrhea