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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02137083
Other study ID # Fudan BR2014-13
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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