A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
NCT ID: NCT02137083
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2014-04-30
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients
NCT02383030
Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer
NCT05594082
The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer
NCT03202862
Anti-HER2 Therapy + Fulvestrant/Capecitabine in Women With HR+, HER2+, Non-visceral Metastases Stage IV Breast Cancer
NCT04337658
Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
NCT06344793
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Docetaxel Plus Fulvestrant
Docetaxel:75mg/m2 D2 every 21 days
Fulvestrant:500mg D1, D15, D29, D57, every 28 days later
Docetaxel
75mg/m2 D2 every 21 days
Fulvestrant
500mg D1, D15, D29, D57, every 28 days later
Docetaxel
Docetaxel:75mg/m2 D2 every 21 days
Docetaxel
75mg/m2 D2 every 21 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Docetaxel
75mg/m2 D2 every 21 days
Fulvestrant
500mg D1, D15, D29, D57, every 28 days later
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xichun Hu
Vice Director of department of medical oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xichun Hu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Cancer Hospital
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Fudan BR2014-13
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.