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IST Neoadjuvant Abraxane in Newly Diagnosed Breast Cancer

NCT01830244 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nab-Paclitaxel

Nab-Paclitaxel- 125 mg/m2 days 1,8, 15 for 12 weeks

Sponsors & Collaborators

  • Barwon Health

    lead OTHER_GOV

Principal Investigators

  • Mustafa Khasraw, MD · Barwon Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-09-30
Completion
2020-06-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

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 NCT01830244 on ClinicalTrials.gov