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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT02137083
First received: May 6, 2014
Last updated: May 9, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Single-center Randomized Phase 3 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02137083

Contacts
Contact: Xichun Hu, MD, PhD 64175590 ext 5006 huxicun@gmail.com
Contact: Biyun Wang, MD 64175590 ext 5000 wangbiyun@msn.com

Locations
China
Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD    64175590 ext 5006    huxicun@gmail.com   
Contact: Biyun Wang, MD    64175590 ext 5000    wangbiyun@msn.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Xichun Hu, MD, PhD Fudan University
  More Information

No publications provided

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
Study First Received: May 6, 2014
Last Updated: May 9, 2014
Health Authority: China: Ethics Committee

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on September 22, 2014