Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer

Study Overview
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Brief Summary
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To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.

Official Title
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Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer: A Randomized, Controlled, Prospective, Observational Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Toremifene
* Drug: Tamoxifen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥18 years, premenopausal Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy. Leukocyte ≥ 3*109/L; Platelets ≥ 75*109/L; Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal (UNL) range Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range; Written informed consent according to the local ethics committee requirements. Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2; Exclusion Criteria: Histologically confirmed hormonal receptor negative. Have received neoadjuvant/adjuvant endocrine therapy. With metastatic tumor. Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor. Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound. With any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc. With any of complications that will decrease sex hormone level:hyperthyroidism，hypothyroidism，liver cirrhosis，severe malnutrition，Turner's syndrome，sex hormone synthetase deficiency, intracranial tumor, pituitary atrophy, etc. Ovarian ablation or suppression With severe non-malignant co-morbidity that will influence long-term follow up. With severe hepatic dysfunction, Child-Pugh C. With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse. Known severe hypersensitivity to any drugs in this study;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: toremifene<br>patients who will be treated with toremifene. | Drug: Toremifene<br>* patients will take toremifene 60 mg qd.<br>* Other names: Fareston;|
| Active Comparator: tamoxifen<br>patients who will be treated with tamoxifen. | Drug: Tamoxifen<br>* patients will take tamoxifen 10 mg bid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of ovarian cyst | Ovarian cyst is defined as a purely liquid-filled structure that was equal to or exceeded 2 cm in its largest diameter detected by transvaginal ultrasonography.Participants will be required to receive transvaginal ultrasonography every 3 months. | participants will be followed during the first year of endocrine therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of endometrial thickening | Endometrial thickness as measured with transvaginal ultrasonography is equal to or exceeded 8mm.Participants will be required to receive transvaginal ultrasonography every 3 months. | participants will be followed during the first year of endocrine therapy | 
| change of female hormones | Change of follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) as measured every 3 months | participants will be followed during the first year of endocrine therapy | 
| change of blood lipid | Change of blood lipid as measured every 3 months | participants will be followed during the first year of endocrine therapy | 
| change of liver function | change of blood lipid as measured every 3 months | participants will be followed during the first year of endocrine therapy | 
| incidence of fatty liver | Incidence of fatty liver as examined by liver ultrasound every 3 months. | participants will be followed during the first year of endocrine therapy | 
| change of Kupperman index | change of Kupperman index as measured every 3 months. | participants will be followed during the first year of endocrine therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toremifene, premenopausal, endocrine therapy, safety, tamoxifen, operable