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

A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02646735

Acronym

FRIEND

Enrollment

148

Registered

2016-01-06

Start date

2015-12-31

Completion date

2020-12-31

Last updated

2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Detailed 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

Interventions

DRUGFulvestrant 500 mg

Fulvestrant 500mg will be given monthly.

DRUGExemestane 25 mg

Exemestane 25mg will be given once daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
PFS	3 years	To compare the efficacy of Fulvestrant 500 mg with the patients treated with Exemestane 25mg as first line setting in terms of progression-free survival.

Secondary

Measure	Time frame	Description
ORR	3 years	To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.

Countries

China

Contacts

Primary ContactXU Binghe, MD

wangjiayu8778@sina.com86-10-87788495

Backup ContactWANG Jiayu, MD