Back to resultsChemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
Primary Purpose
Carcinoma Breast Stage IV
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Abraxane,Cyclophosphamide,Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma Breast Stage IV focused on measuring triple negative breast cancer, autologous hematopoietic stem-cell transplantation
Eligibility 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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metastatic triple negative breast cancer
Arm Description
Abraxane,Cyclophosphamide,Carboplatin
Outcomes
Primary Outcome Measures
Progression free Survival
Secondary Outcome Measures
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02183805
Brief Title
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
Official Title
Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty accruing subjects the study accrual was closed
Study Start Date
June 17, 2014 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma Breast Stage IV
Keywords
triple negative breast cancer, autologous hematopoietic stem-cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metastatic triple negative breast cancer
Arm Type
Experimental
Arm Description
Abraxane,Cyclophosphamide,Carboplatin
Intervention Type
Drug
Intervention Name(s)
Abraxane,Cyclophosphamide,Carboplatin
Other Intervention Name(s)
Abraxane 800 mg/m2, Cyclophosphamide 3g/m2, Carboplatin 800 mg/m2
Intervention Description
High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin
Primary Outcome Measure Information:
Title
Progression free Survival
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-Yu Yuan, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
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