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

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ClinicalTrials.gov Identifier: NCT02137083
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

Study Description
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Brief Summary:
Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Docetaxel Drug: Fulvestrant Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : April 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 Weeks ]
  2. Overall Survival [ Time Frame: 6 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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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 Posted: May 13, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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