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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fulvestrant 500 mg

Exemestane 25 mg

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

National Cancer Institute, Cancer Hospital Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fulvestrant

Exemestane

Arm Description

Fulvestrant 500 mg

Exemestane 25mg

Outcomes

Primary Outcome Measures

PFS

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 Outcome Measures

ORR

To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.

Full Information

NCT ID

NCT02646735

First Posted

January 4, 2016

Last Updated

December 30, 2016

Sponsor

Chinese Academy of Medical Sciences

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02646735

Brief Title

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

Acronym

FRIEND

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fulvestrant

Arm Type

Experimental

Arm Description

Fulvestrant 500 mg

Arm Title

Exemestane

Arm Type

Active Comparator

Arm Description

Exemestane 25mg

Intervention Type

Drug

Intervention Name(s)

Fulvestrant 500 mg

Intervention Description

Fulvestrant 500mg will be given monthly.

Intervention Type

Drug

Intervention Name(s)

Exemestane 25 mg

Intervention Description

Exemestane 25mg will be given once daily.

Primary Outcome Measure Information:

Title

PFS

Description

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

ORR

Description

To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.

Time Frame

3 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

XU Binghe, MD

Phone

86-10-87788495

Ext

0000

wangjiayu8778@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

WANG Jiayu, MD

Phone

86-10-87788495

Ext

0000

wangjiayu8778@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

XU Binghe, MD

Organizational Affiliation

Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Binghe XU, M.D.

Phone

86-10-88788826

xubinghe@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Jiayu WANG, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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