Breast Cancer
Conditions
Keywords
operable, premenopausal, endocrine therapy, safety, tamoxifen, toremifene
Brief summary
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.
Interventions
DRUGToremifene
patients will take toremifene 60 mg qd.
DRUGTamoxifen
patients will take tamoxifen 10 mg bid.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women aged ≥18 years, premenopausal 2. Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive 3. 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. 4. 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. 5. Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;
Exclusion criteria
1. Histologically confirmed hormonal receptor negative. 2. Have received neoadjuvant/adjuvant endocrine therapy. 3. With metastatic tumor. 4. Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor. 5. Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound. 6. With any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc. 7. 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. 8. Ovarian ablation or suppression 9. With severe non-malignant co-morbidity that will influence long-term follow up. 10. With severe hepatic dysfunction, Child-Pugh C. 11. With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse. 12. Known severe hypersensitivity to any drugs in this study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of ovarian cyst | participants will be followed during the first year of endocrine therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of female hormones | participants will be followed during the first year of endocrine therapy | Change of follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) as measured every 3 months |
| change of blood lipid | participants will be followed during the first year of endocrine therapy | Change of blood lipid as measured every 3 months |
| incidence of endometrial thickening | participants will be followed during the first year of endocrine therapy | Endometrial thickness as measured with transvaginal ultrasonography is equal to or exceeded 8mm.Participants will be required to receive transvaginal ultrasonography every 3 months. |
| incidence of fatty liver | participants will be followed during the first year of endocrine therapy | Incidence of fatty liver as examined by liver ultrasound every 3 months. |
| change of Kupperman index | participants will be followed during the first year of endocrine therapy | change of Kupperman index as measured every 3 months. |
| change of liver function | participants will be followed during the first year of endocrine therapy | change of blood lipid as measured every 3 months |
Countries
China
Outcome results
None listed