Clinical trial NCT02344940: Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer
Official title: Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer: A Randomized, Controlled, Prospective, Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: operable
premenopausal
endocrine therapy
safety
tamoxifen
toremifene
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: incidence of ovarian cyst
timeFrame: participants will be followed during the first year of endocrine therapy
Secondary outcomes:
measure: incidence of endometrial thickening
timeFrame: participants will be followed during the first year of endocrine therapy
measure: change of female hormones
timeFrame: participants will be followed during the first year of endocrine therapy
measure: change of blood lipid
timeFrame: participants will be followed during the first year of endocrine therapy
measure: change of liver function
timeFrame: participants will be followed during the first year of endocrine therapy
measure: incidence of fatty liver
timeFrame: participants will be followed during the first year of endocrine therapy
measure: change of Kupperman index
timeFrame: participants will be followed during the first year of endocrine therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Kunwei Shen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.