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

Breast Cancer Clinical Trial

— TTOS  

Official title:

Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer: A Randomized, Controlled, Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344940
• Other study ID #: RJBC1401
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: August 2018

Study information

• Verified date: September 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Toremifene
patients will take toremifene 60 mg qd.
• Tamoxifen
patients will take tamoxifen 10 mg bid.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of ovarian cyst	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.	participants will be followed during the first year of endocrine therapy
Secondary	incidence of endometrial thickening	Endometrial thickness as measured with transvaginal ultrasonography is equal to or exceeded 8mm.Participants will be required to receive transvaginal ultrasonography every 3 months.	participants will be followed during the first year of endocrine therapy
Secondary	change of female hormones	Change of follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) as measured every 3 months	participants will be followed during the first year of endocrine therapy
Secondary	change of blood lipid	Change of blood lipid as measured every 3 months	participants will be followed during the first year of endocrine therapy
Secondary	change of liver function	change of blood lipid as measured every 3 months	participants will be followed during the first year of endocrine therapy
Secondary	incidence of fatty liver	Incidence of fatty liver as examined by liver ultrasound every 3 months.	participants will be followed during the first year of endocrine therapy
Secondary	change of Kupperman index	change of Kupperman index as measured every 3 months.	participants will be followed during the first year of endocrine therapy