Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
Phase 2
Terminated
- Conditions
- Carcinoma Breast Stage IV
- Interventions
- Drug: Abraxane,Cyclophosphamide,Carboplatin
- Registration Number
- NCT02183805
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metastatic triple negative breast cancer Abraxane,Cyclophosphamide,Carboplatin Abraxane,Cyclophosphamide,Carboplatin
- Primary Outcome Measures
Name Time Method Progression free Survival 24 months
- Secondary Outcome Measures
Name Time Method Overall Survival 24 months
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China