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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| toremifene | Experimental | patients who will be treated with toremifene. |
|
| tamoxifen | Active Comparator | patients who will be treated with tamoxifen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toremifene | Drug | patients will take toremifene 60 mg qd. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kunwei Shen, Professor | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32677982 | Derived | Hong J, Huang J, Shen L, Zhu S, Gao W, Wu J, Huang O, He J, Zhu L, Chen W, Li Y, Chen X, Shen K. A prospective, randomized study of Toremifene vs. tamoxifen for the treatment of premenopausal breast cancer: safety and genital symptom analysis. BMC Cancer. 2020 Jul 16;20(1):663. doi: 10.1186/s12885-020-07156-x. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017312 | Toremifene |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Tamoxifen | Drug | patients will take tamoxifen 10 mg bid. |
|
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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |