Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Toremifene; Drug: Tamoxifen

• Registration Number: NCT02344940
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-18
• Study First Posted: 2015-01-26
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
toremifene	Toremifene	patients who will be treated with toremifene.
tamoxifen	Tamoxifen	patients who will be treated with tamoxifen.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
change of liver function	participants will be followed during the first year of endocrine therapy	change of blood lipid as measured every 3 months

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China