Breast Cancer Patients in Premenopausal, Estrogen and/or Progesterone Receptor Positive
Conditions
Brief summary
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.
Interventions
DRUGtoremifene or tamoxifen
Sponsors
Fengxi Su
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival outcomes: disease free survival | up to 5 years |
| 5-year overall survival | up to 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| side effects effects of therapies | Follow-up period,up to 5 years | the primary safety measures are Hepatic function and blood lipid |
| Incidence of adverse events | follow-up period, up to 5 years | Adverse events including hot flashes, irregular menses and others. |
Countries
China
Outcome results
None listed