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

Carcinoma Breast Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02183805
• Other study ID #: SYSUCC-004
• Status: Terminated
• Phase: Phase 2
• Start date: June 17, 2014
• Est. completion date: December 15, 2020

Study information

• Verified date: July 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma Breast Stage IV
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Abraxane,Cyclophosphamide,Carboplatin
High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free Survival		24 months
Secondary	Overall Survival		24 months