NCT02646735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Dec 2015

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

4 years

First QC Date

January 4, 2016

Last Update Submit

December 30, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (1)

  • ORR

    3 years

Study Arms (2)

Fulvestrant

EXPERIMENTAL

Fulvestrant 500 mg

Drug: Fulvestrant 500 mg

Exemestane

ACTIVE COMPARATOR

Exemestane 25mg

Drug: Exemestane 25 mg

Interventions

Fulvestrant 500 mgDRUG

Fulvestrant 500mg will be given monthly.

Fulvestrant
Exemestane 25 mgDRUG

Exemestane 25mg will be given once daily.

Exemestane

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

  • Wang J, Cai L, Song Y, Sun T, Tong Z, Teng Y, Li H, Ouyang Q, Chen Q, Cui S, Yin Y, Liao N, Sun Q, Feng J, Wang X, Xu B. Clinical efficacy of fulvestrant versus exemestane as first-line therapies for Chinese postmenopausal oestrogen-receptor positive /human epidermal growth factor receptor 2 -advanced breast cancer (FRIEND study). Eur J Cancer. 2023 May;184:73-82. doi: 10.1016/j.ejca.2023.02.007. Epub 2023 Feb 15.

    PMID: 36905771DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrantexemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • XU Binghe, MD

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

XU Binghe, MD

CONTACT

86-10-87788495wangjiayu8778@sina.com

WANG Jiayu, MD

CONTACT

86-10-87788495wangjiayu8778@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the medical department

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 6, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)