Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients (FRIEND)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Fulvestrant 500 mg; Drug: Exemestane 25 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02646735

10982 (Registry Identifier)

Details and patient eligibility

About

A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.

Full description

To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy

Enrollment: 148 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent document on file;
• Age over 60 years;
• Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
• Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
• ER + and/or PgR +;
• Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
• WHO performance status 0, 1 or 2;
• Patients with life expectancy of more than 3 months.

Exclusion criteria

• Presence of life-threatening metastatic visceral disease;
• Previous systemic chemotherapy for advanced breast cancer;
• Received systemic endocrine therapy for advanced disease;
• Extensive radiation therapy within the last 4 weeks ;
• Platelets < 100*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
• Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
• History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Fulvestrant

Experimental group

Description:

Fulvestrant 500 mg

Treatment:

Drug: Fulvestrant 500 mg

Exemestane

Active Comparator group

Description:

Exemestane 25mg

Treatment:

Drug: Exemestane 25 mg