drugset / Trial / NCT02670109

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

NCT02670109

NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 16 mg/kg Oral
Subject Carboplatin Small molecule 1400 unknown Intravenous
Subject Cyclophosphamide Other / unclassified 80 mg/kg Intravenous
Subject carmustine Small molecule 300 mg/m2 Intravenous