Status:
TERMINATED
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Carcinoma Breast Stage IV
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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 gi...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02183805
Start Date
June 17 2014
End Date
December 15 2020
Last Update
July 23 2021
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060