Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer

Sponsor

Sun Yat-sen University (Other)

Overall Status

Terminated

CT.gov ID

NCT02183805

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Breast Stage IV	Drug: Abraxane,Cyclophosphamide,Carboplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer

Actual Study Start Date :

Jun 17, 2014

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metastatic triple negative breast cancer Abraxane,Cyclophosphamide,Carboplatin	Drug: Abraxane,Cyclophosphamide,Carboplatin High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin Other Names: Abraxane 800 mg/m2 Cyclophosphamide 3g/m2 Carboplatin 800 mg/m2

Arm

Intervention/Treatment

Experimental: Metastatic triple negative breast cancer

Abraxane,Cyclophosphamide,Carboplatin

Drug: Abraxane,Cyclophosphamide,Carboplatin

High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin

Other Names:

Abraxane 800 mg/m2

Cyclophosphamide 3g/m2

Carboplatin 800 mg/m2

Outcome Measures

Primary Outcome Measures

Progression free Survival [24 months]

Secondary Outcome Measures

Overall Survival [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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.