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

Metastatic Breast Cancer Clinical Trial

Official title:

A Prospective Single-center Randomized Phase 2 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137083
• Other study ID #: Fudan BR2014-13
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2014
• Last updated: January 21, 2018
• Start date: April 2014
• Est. completion date: July 2017

Study information

• Verified date: January 2018
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Docetaxel
75mg/m2 D2 every 21 days
• Fulvestrant
500mg D1, D15, D29, D57, every 28 days later

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		6 weeks
Secondary	Overall Response Rate		6 Weeks
Secondary	Overall Survival		6 Weeks