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

NCT02670109 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-14

No results posted yet for this study

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, with a higher risk of recurrence and a poor survival once that recurrence occurs. On the other hand, there is not a specific adjuvant or neoadjuvant treatment for these patients. Since autologous hematopoietic stem cell transplantation (HSCT) allows the usage of higher doses of chemotherapy, which results in higher cellular destruction with a decrease of hematological toxicity, it is proposed that this procedure is able to improve prognosis in TNBC patients with no pathologic complete response after neoadjuvant chemotherapy.

Conditions

  • Triple-Negative Invasive Breast Carcinoma
  • Residual Tumor

Interventions

DRUG

Carmustine

300mg/m2, IV, in 3 hours, during day -4

DRUG

Cyclophosphamide

80mg/kg, IV, in 2 hours, during two days -2, -3

DRUG

Carboplatin

1400/m2, IV, in 1 hour, during day -3

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Transfusion, in 3 hours, during day 0

DRUG

Busulfan

16mg/kg, Oral, during day -4

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Eucario Leon Rodriguez, M.D. · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  • Monica M Rivera Franco, M.D.,MSc · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-11-30
Completion
2021-11-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02670109 on ClinicalTrials.gov