IST Neoadjuvant Abraxane in Newly Diagnosed Breast Cancer
Status:
Unknown status
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
The aim of this project is to evaluate tailored primary systemic therapy with sequential nab
paclitaxel and epirubicin and cyclophosphamide in early breast cancer. This study will be an
open label phase II clinical trial. The hypothesis is that tailored neoadjuvant chemotherapy
with sequential nab paclitaxel and epirubicin and cyclophosphamide is feasible and achieves
high response rates. It is proposed that 60 patients will be enrolled in this study including
40 patients which are likely to have chemotherapy sensitive tumors and 20 patients who have
ER positive tumors and are more likely to respond to hormonal treatment as an exploratory
cohort. The target population is women with early breast cancer who are eligible for primary
systemic therapy. The overall response rate in the breast will be measured. Secondary
endpoints will include response rates in axillary lymph nodes, safety and tolerability and
the rate of breast conservation. Participants will have a blood test to determine a specific
genotype status that may help in predicting sensitivity to chemotherapy. This genotype test
result is exploratory and will not influence selection of therapy for participants. Patients
will also be given the option of having he their tumour tissues used in laboratory studies
involving isolating cancer initiating cells from the tumor to subsequently generate breast
cancer models in the laboratory and using aptamers (chemical antibodies) to target tumours.