A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Fulvestrant

• Registration Number: NCT02137083
• Lead Sponsor: Fudan University

Brief Summary

Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer

Detailed Description

Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-21
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Postmenopausal female between 18 and 70 years old
• ECOG performance status of ≤ 1
• Life expectancy more than 3 months
• Histologically confirmed metastatic breast cancer
• ER and&or PR pqositive, HER2-negative
• Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone
• No pretreated chemotherapy for metastatic disease
• Have at least one target lesion according to RECIST 1.1
• No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment
• Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>50ml/min

Exclusion Criteria

• Pregnant or lactating women
• Evidence of CNS metastasis
• Seriously uncontrolled infection
• History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pretreated with Fulvestrant
• Pretreated with two or more lines of endocrine therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel Plus Fulvestrant	Docetaxel	Docetaxel:75mg/m2 D2 every 21 days Fulvestrant:500mg D1, D15, D29, D57, every 28 days later
Docetaxel Plus Fulvestrant	Fulvestrant	Docetaxel:75mg/m2 D2 every 21 days Fulvestrant:500mg D1, D15, D29, D57, every 28 days later
Docetaxel	Docetaxel	Docetaxel:75mg/m2 D2 every 21 days

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	6 weeks

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	6 Weeks
Overall Survival	6 Weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China