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Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy

NCT01594177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-03-13

No results posted yet for this study

Summary

Anthracycline/taxane based combination chemotherapy of at least 18 weeks represents the standard of care in the neoadjuvant setting. In HER2 positive disease trastuzumab is given simultaneously. Neoadjuvant anthracycline-taxane-based chemotherapy given simul-taneously with trastuzumab achieves a pCR rate of approx. 40%. Recent data showed that a double blockade of the HER2 receptor (e.g. trastuzumab + lapatinib; trastuzumab + pertuzumab) given together with a few cycles of chemotherapy can increase the pCR rate by approximately 20%. So far, there is uncertainty, if afatinib (BIBW 2992), an irreversible HER family blocker can lead to an even more complete blockade of the HER2 pathway when given in combination with trastuzumab. The neoadjuvant setting provides the unique opportunity to assess precisely and at short term the effect of systemic treatment by assessing the pCR at surgery. It also allows treating patients with HER2 positive breast cancer before surgery without standard trastuzumab treatment, as, according to current guideline, trastuzumab can also be given sequentially after surgery. The aim of the study is to show that chemotherapy + trastuzumab + afatinib can achieve significant pCR rates.

Conditions

  • Unilateral HER2 Positive Breast Cancer

Interventions

DRUG

Afatinib

20 mg daily for 17 weeks (first two weeks every second day).

DRUG

Trastuzumab

First cycle: loading dose 8 mg/kg (day 1 q day 22), thereafter maintenance dose for 9 cycles: 6 mg/kg (day 1 q day 22).

DRUG

Paclitaxel

80 mg/m² i.v. given weekly on day 1 q day 8 for 12 weeks.

DRUG

Epirubicin

90 mg/m² i.v. given on day 1 q day 22 for 4 cycles.

DRUG

Cyclophosphamide

600 mg/m² i.v. given on day 1 q day 22 for 4 cycles.

Sponsors & Collaborators

Principal Investigators

  • Claus A Hanusch, MD, PhD · Rotkreuzklinikum München, 80634 München, Rotkreuzplatz 8

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

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 NCT01594177 on ClinicalTrials.gov