Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients

Phase 2

• Conditions: Triple-Negative Invasive Breast Carcinoma; Residual Tumor
• Interventions: Drug: Carmustine; Drug: Cyclophosphamide; Drug: Carboplatin; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Drug: Busulfan

• Registration Number: NCT02670109
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Its incidence is approximately 180,000 cases per year. TNBC are known to be more aggressive with poor prognosis specially when no pathologic complete response (pCR) is achieved after neoadjuvant chemotherapy, ...

Detailed Description

Triple-negative breast cancer (TNBC) accounts for approximately 15%-25% of all breast cancer cases. TNBC are usually high-grade tumors, presented among younger women, African American and Hispanic women have a higher risk; generally in advanced stages when diagnosed, with visceral recurrence (liver, lung, brain). Standard treatment is surgery with adjuvant c...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-01
• Study Start: 2018-02-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14
• Primary Completion: 2020-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Triple Negative Breast Cancer diagnosis (no expression of hormonal receptors or Her2/neu)
• Previous administration of neoadjuvant chemotherapy (60 days maximum)
• No evidence of metastatic disease at inclusion
• Residual tumor in the breast and/or lymph nodes
• Normal renal, liver, heart, lung, and hematopoietic function

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Exclusion Criteria

• Pregnancy
• Disease progression during neoadjuvant therapy
• Other tumors
• Non triple negative breast cancer diagnosis
• Pathological Complete Response achieved

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unique	Autologous Hematopoietic Stem Cell Transplantation	Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.
Unique	Carboplatin	Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.
Unique	Carmustine	Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.
Unique	Cyclophosphamide	Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.
Unique	Busulfan	Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.

Primary Outcome Measures

Name	Time	Method
Overall Survival	One year	Time from diagnosis to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	One year	Time from ending primary treatment to relapse of the disease.

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Distrito Federal, Mexico