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

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02344940

Collaborator

(none)

104

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Toremifene Drug: Tamoxifen	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: toremifene patients who will be treated with toremifene.	Drug: Toremifene patients will take toremifene 60 mg qd. Other Names: Fareston
Active Comparator: tamoxifen patients who will be treated with tamoxifen.	Drug: Tamoxifen patients will take tamoxifen 10 mg bid.

Arm

Intervention/Treatment

Experimental: toremifene

patients who will be treated with toremifene.

Drug: Toremifene

patients will take toremifene 60 mg qd.

Other Names:

Fareston

Active Comparator: tamoxifen

patients who will be treated with tamoxifen.

Drug: Tamoxifen

patients will take tamoxifen 10 mg bid.

Outcome Measures

Primary Outcome Measures

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

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women aged ≥18 years, premenopausal
Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive
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.
Leukocyte ≥ 3109/L; Platelets ≥ 75109/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.
Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;

Exclusion Criteria:

Histologically confirmed hormonal receptor negative.
Have received neoadjuvant/adjuvant endocrine therapy.
With metastatic tumor.
Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
With any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc.
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.
Ovarian ablation or suppression
With severe non-malignant co-morbidity that will influence long-term follow up.
With severe hepatic dysfunction, Child-Pugh C.
With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse.
Known severe hypersensitivity to any drugs in this study;