Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients

Fengxi Su

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Estrogen and/or Progesterone Receptor Positive; Breast Cancer Patients in Premenopausal

Treatments: Drug: toremifene or tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT02132000

BCSCO002

Details and patient eligibility

About

In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.

Enrollment: 3,036 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Breast cancer
• Received standard treatment (chemotherapy, operation, or radiotherapy)
• premenopausal
• estrogen and/or progesterone receptor positive

Exclusion criteria

• Metastatic tumors
• During pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,036 participants in 2 patient groups

tamoxifen

Active Comparator group

Description:

tamoxifen,20mg/day

Treatment:

Drug: toremifene or tamoxifen

toremifene

Experimental group

Description:

toremifene,60mg/day

Treatment:

Drug: toremifene or tamoxifen