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Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT02183805
Recruitment Status : Recruiting
First Posted : July 8, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

Study Description
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Brief Summary:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

Condition or disease Intervention/treatment Phase
Carcinoma Breast Stage IV Drug: Abraxane,Cyclophosphamide,Carboplatin Phase 2

Detailed Description:
To explore the progression-free survival of patients with metastatic triple-negative breast cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose chemotherapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer
Study Start Date : June 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Metastatic triple negative breast cancer
Abraxane,Cyclophosphamide,Carboplatin
 Drug: Abraxane,Cyclophosphamide,Carboplatin
High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin
Other Names:
  • Abraxane 800 mg/m2
  • Cyclophosphamide 3g/m2
  • Carboplatin 800 mg/m2


Outcome Measures
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Primary Outcome Measures :
  1. Progression free Survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
  • Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).
  • Obtained complete response or Good partial response after first line chemotherapy.
  • Normal organ function required prior to study entry.
  • Willingness to comply with treatment plans and other study procedures.

Exclusion Criteria:

  • Uncontrolled central nervous system (CNS) involvement with disease
  • Fertile women unwilling to use contraceptive techniques during treatment
  • Females who are pregnant
  • Organ dysfunction.
  • Patients may not be receiving any other investigational agents.
Contacts and Locations
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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): NCT02183805


Contacts
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Contact: Zhong-Yu Yuan, M.D. 86-20-87343794 yuanzhygz@163.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhong-Yu Yuan, M.D.    86-20-87343794    yuanzhy@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhong-Yu Yuan, M.D. Sun Yat-sen University
More Information
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Responsible Party: Zhong-yu Yuan, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02183805     History of Changes
Other Study ID Numbers: SYSUCC-004
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Zhong-yu Yuan, Sun Yat-sen University:
triple negative breast cancer
autologous hematopoietic stem-cell transplantation
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Carboplatin
Albumin-Bound Paclitaxel
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators