Clinical trial · Interventional
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer
NCT02183805CI-TRIAL-00052863terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty accruing subjects the study accrual was closed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Breast Stage IV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane,Cyclophosphamide,Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metastatic triple negative breast cancer
- description
- Abraxane,Cyclophosphamide,Carboplatin
- interventionNames
- Drug: Abraxane,Cyclophosphamide,Carboplatin
Primary outcomes (1)
- measure
- Progression free Survival
- timeFrame
- 24 months
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.