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

This study has been terminated.

(The enrollment is too slow.)

Sponsor:

ClinicalTrials.gov Identifier:

NCT02137083

First Posted: May 13, 2014

Last Update Posted: April 28, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Xichun Hu, Fudan University

Purpose

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

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Docetaxel Drug: Fulvestrant	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Docetaxel Fulvestrant

U.S. FDA Resources

Further study details as provided by Xichun Hu, Fudan University:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Overall Response Rate [ Time Frame: 6 Weeks ]
Overall Survival [ Time Frame: 6 Weeks ]


Enrollment:	22
Study Start Date:	April 2014
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Docetaxel Plus Fulvestrant Docetaxel:75mg/m2 D2 every 21 days Fulvestrant:500mg D1, D15, D29, D57, every 28 days later	Drug: Docetaxel 75mg/m2 D2 every 21 days Other Name: Taxotere Drug: Fulvestrant 500mg D1, D15, D29, D57, every 28 days later Other Name: Faslodex
Active Comparator: Docetaxel Docetaxel:75mg/m2 D2 every 21 days	Drug: Docetaxel 75mg/m2 D2 every 21 days Other Name: Taxotere

Detailed Description:

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137083

Locations


China
Fudan University Cancer Hospital
Shanghai, China, 200032

Sponsors and Collaborators

Fudan University

Investigators


Principal Investigator:	Xichun Hu, MD, PhD	Fudan University

More Information


Responsible Party:	Xichun Hu, Vice Director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier:	NCT02137083 History of Changes
Other Study ID Numbers:	Fudan BR2014-13
First Submitted:	May 6, 2014
First Posted:	May 13, 2014
Last Update Posted:	April 28, 2017
Last Verified:	April 2017

Keywords provided by Xichun Hu, Fudan University:


Chemotherapy Endocrine therapy Docetaxel Fulvestrant

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel Fulvestrant Estradiol Antineoplastic Agents Tubulin Modulators Antimitotic Agents	Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Estrogens Hormones

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