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

Fudan University

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02137083

Fudan BR2014-13

Details and patient eligibility

About

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

Full description

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

Enrollment: 22 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Docetaxel Plus Fulvestrant

Experimental group

Description:

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

Treatment:

Drug: Docetaxel

Drug: Fulvestrant

Docetaxel

Active Comparator group

Description:

Docetaxel:75mg/m2 D2 every 21 days

Treatment:

Drug: Docetaxel