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Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02207361
Recruitment Status : Unknown
Verified June 2013 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : August 4, 2014
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Paclitaxel, Carboplatin Drug: Paclitaxel, Epirubicin Phase 4

Detailed Description:
A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer
Study Start Date : December 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Paclitaxel, Carboplatin,injection
Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
Drug: Paclitaxel, Carboplatin
Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.

Active Comparator: Paclitaxel, Epirubicin,injection
Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.
Drug: Paclitaxel, Epirubicin
Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.




Primary Outcome Measures :
  1. RECIST 1.1 [ Time Frame: -7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks.

Exclusion Criteria:

  • Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe Infection.

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): NCT02207361


Contacts
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Contact: Zhongsheng Tong, Master +86 18622221181 18622221181@163.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300061
Contact: Zhongsheng Tong, Master         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Director: Zhongsheng Tong, Master Tianjin Medical University Cancer Institute and Hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02207361     History of Changes
Other Study ID Numbers: CIH-TZS-20140421-02
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: June 2013

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors