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

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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