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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-17

Study Completion Date

2020-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carcinoma Breast Stage IV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metastatic triple negative breast cancer

Abraxane,Cyclophosphamide,Carboplatin

Group Type EXPERIMENTAL

Abraxane,Cyclophosphamide,Carboplatin

Intervention Type DRUG

High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin

Interventions

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Abraxane,Cyclophosphamide,Carboplatin

High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin

Intervention Type DRUG

Other Intervention Names

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Abraxane 800 mg/m2 Cyclophosphamide 3g/m2 Carboplatin 800 mg/m2

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes