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

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
|
- Progression Free Survival [ Time Frame: 6 weeks ]
- Overall Response Rate [ Time Frame: 6 Weeks ]
- Overall Survival [ Time Frame: 6 Weeks ]

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

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
China | |
Fudan University Cancer Hospital | |
Shanghai, China, 200032 |
Principal Investigator: | Xichun Hu, MD, PhD | Fudan University |
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 |