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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02137083

Enrollment

Registered

2014-05-13

Start date

2014-04-30

Completion date

2017-07-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Chemotherapy, Endocrine therapy, Docetaxel, Fulvestrant

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

Interventions

DRUGDocetaxel

75mg/m2 D2 every 21 days

DRUGFulvestrant

500mg D1, D15, D29, D57, every 28 days later

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	6 weeks

Secondary

Measure	Time frame
Overall Response Rate	6 Weeks
Overall Survival	6 Weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026