Breast Cancer Patients in Premenopausal Clinical Trial
In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.
| Status | Recruiting |
| Enrollment | 3036 |
| Est. completion date | May 2020 |
| Est. primary completion date | May 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of Breast cancer - Received standard treatment (chemotherapy, operation, or radiotherapy) - premenopausal - estrogen and/or progesterone receptor positive Exclusion Criteria: - Metastatic tumors - During pregnancy or lactation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Breast cancer center of Sun Yat-sen Memorial Hospital | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Fengxi Su |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | survival outcomes: disease free survival | up to 5 years | No | |
| Primary | 5-year overall survival | up to 5 years | No | |
| Secondary | side effects effects of therapies | the primary safety measures are Hepatic function and blood lipid | Follow-up period,up to 5 years | Yes |
| Secondary | Incidence of adverse events | Adverse events including hot flashes, irregular menses and others. | follow-up period, up to 5 years | Yes |