A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by Fudan University
Sponsor:
Fudan University
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT02137083
First received: May 6, 2014
Last updated: January 5, 2015
Last verified: January 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
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
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: | January 5, 2015 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Chemotherapy Endocrine therapy Docetaxel Fulvestrant |
Additional relevant MeSH terms:
|
Docetaxel Fulvestrant Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Hormonal Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on March 03, 2015