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

NCT02183805 | Terminated Phase 2 DMC

• 1 other identifier: SYSUCC-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma Breast Stage IV

Keywords

triple negative breast cancer; autologous hematopoietic stem-cell transplantation

Outcome Measures

Primary Outcomes (1)

• Progression free Survival

  24 months

Secondary Outcomes (1)

• Overall Survival

  24 months

Study Arms (1)

Metastatic triple negative breast cancer

EXPERIMENTAL

Abraxane,Cyclophosphamide,Carboplatin

Drug: Abraxane,Cyclophosphamide,Carboplatin

Interventions

Abraxane,Cyclophosphamide,Carboplatin DRUG

High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin

Also known as: Abraxane 800 mg/m2, Cyclophosphamide 3g/m2, Carboplatin 800 mg/m2

Metastatic triple negative breast cancer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; CAC protocol; Cyclophosphamide; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Coordination Complexes

Study Officials

• Zhong-Yu Yuan, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 8, 2014
• Study Start: June 17, 2014
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)