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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02183805

Enrollment

Registered

2014-07-08

Start date

2014-06-17

Completion date

2020-12-15

Last updated

2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma Breast Stage IV

Keywords

triple negative breast cancer, autologous hematopoietic stem-cell transplantation

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.

Interventions

DRUGAbraxane,Cyclophosphamide,Carboplatin

High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Progression free Survival	24 months

Secondary

Measure	Time frame
Overall Survival	24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026