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

Breast Cancer Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02646735
• Other study ID #: 10982
• Status: Recruiting
• Phase: Phase 2
• First received: January 4, 2016
• Last updated: December 30, 2016
• Start date: December 2015
• Est. completion date: December 2020

Study information

• Verified date: December 2016
• Source: Chinese Academy of Medical Sciences
• Contact: XU Binghe, MD
• Phone: 86-10-87788495
• Email: wangjiayu8778[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fulvestrant 500 mg
Fulvestrant 500mg will be given monthly.
• Exemestane 25 mg
Exemestane 25mg will be given once daily.

Locations

Country	Name	City	State
China	National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	ORR	To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.	3 years	Yes