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Bevacizumab, Everolimus (RAD001), and Lapatinib as Neoadjuvant Chemotherapy Regimes for Primary Breast Cancer

NCT00567554 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2600

Last updated 2016-02-10

No results posted yet for this study

Summary

Anthracycline-taxane based chemotherapy regimens are recommended mainly by current guidelines for neoadjuvant application of systemic treatment. The addition of other cytotoxic agents, e.g. antimetabolites, vincaalkaloids, or platinum salts resulted in marginal increase in efficacy, but was associated also with an increase in toxicity. Recently, only the addition of the Her-2 antibody trastuzumab has significantly improved pathologic response rate.

Therefore, two major strategies are followed in current research projects:

* To improve the selection of patients according to their tumors' sensitivity to chemotherapy.
* To implement small molecules with specific mechanism of action.

Within the GeparQuinto trial, the first strategy is followed by:

* The PREDICT substudy. A gene signature specific for the response to anthracyclines and taxanes will be prospectively evaluated for its ability to identify patients with chance higher than 50% for a pCR. The results may leed to a better risk-benefit ratio for the use of conventional chemotherapy.
* Adapting further chemotherapy to the response of the tumor to the first couple of chemotherapy cycles. Based on the previous experience made by the GeparTrio study, patients not responding early have a low chance to respond with a pCR irrespective of the type of chemotherapy. So, if further chemotherapy is planned, therapy should be selected according to a favorable toxicity profile.

The second strategy is followed by investigating in three parallel group comparisons the efficiency of three distinct small molecules which appear to be generally active in breast cancer:

* Bevacizumab, an inhibitor of the VEGF pathway targeting tumor neo-angiogenesis.
* Lapatinib, an inhibitor of the Her-1 and Her-2 receptor tyrosine kinase.
* RAD001 (Everolimus), an inhibitor of the mTOR molecule, a central controller of tumor cell growth and angiogenesis and chemosensitizer.

Treatment for patients participating in the GeparQuinto study will be allocated according to the Her-2 status of the tumor as well as according to the sonographic response after the first 4 cycles of treatment. Experimental therapy with bevacizumab, lapatinib, and everolimus (RAD001) will be randomly added in distinct settings.

Conditions

Interventions

DRUG

epirubicin - cyclophosphamide / docetaxel

DRUG

epirubicin - cyclophosphamide / docetaxel + bevacizumab

DRUG

paclitaxel

DRUG

paclitaxel + everolimus (RAD001)

DRUG

epirubicin - cyclophosphamide / docetaxel + trastuzumab

DRUG

epirubicin - cyclophosphamide / docetaxel + lapatinib

Sponsors & Collaborators

  • AGO Study Group

    collaborator OTHER

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Gunter von Minckwitz, MD, Prof. · GBG Forschungs GmbH

  • Michael Untch, MD, Prof. · AGO Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-08-31
Completion
2015-10-31

Countries

  • Germany

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 NCT00567554 on ClinicalTrials.gov