EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

January 3, 2012 updated by: MediGene

An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is still a major public health problem worldwide, as it is by far the most frequent neoplasm in women. In recent years so-called "profiling of breast cancer" with expression arrays has become common and it was suggested that the results will allow individualization of care. Breast cancer may now be subclassified into luminal, basal, and HER-2 subtypes with distinct differences in prognosis and response to therapy. About 80% of all basal-like-breast cancers possess a so-called "triple-receptor-negative" phenotype.

Patients with "triple receptor negative breast cancer" have a complete absence of hormone receptors incl. HER-2, an aggressive clinical course and a paucity of treatment options. The only therapeutic option is chemotherapy and in this respect the choice of cytostatic agents is limited. Against this background, the study tries to find another therapeutic option by combining a vascular-disrupting activity with the cytostatic effects of paclitaxel in the study drug EndoTAG-1.

Comparison: EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in comparison to paclitaxel (control group)

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • CHU Brugmann
      • Brussels, Belgium, 1000
        • Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles
      • Edegem, Belgium
        • UZ Antwerpen
      • Liège, Belgium
        • CHU Liege
  • France
      • Lille, France
        • Centre Oscar Lambret
      • Nice, France
        • Cente Antoine Lacassagne
      • Paris, France
        • Institut Curie
      • Tours, France
        • Hôpital de Jour Centre Henri Kaplan
      • Villejuif, France
        • Institut Gustave Roussy
  • India
      • Ahmedabad, India
        • Vedanta Institute of Medical Science
      • Bangalore, India
        • Bangalore Institute of Oncology
      • Jaipur, India
        • Searoc Cancer Center
      • Kochin, India
        • Lakeshore Hospital
      • Pune, India
        • Deenanath Mangeshkar Hospital
      • Thane, India
        • Kaushalya Medical Foundation
  • Poland
      • Gdansk, Poland
        • Wojewodzkie Centrum Onkologii
      • Gliwice, Poland
        • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
      • Lublin, Poland
        • Instytut im. M. Sklodowskiej-Curie
      • Olsztyn, Poland
        • NZOZ Grupowa Specjalistyczna
      • Poznan, Poland
        • Klinika Onkologii Adadmii Medycznej
  • Romania
      • Bucharest, Romania
        • Institute of Oncology "Prof. Dr. Al. Trestioreanu"
      • Cluj Napoca, Romania
        • Institute of Oncology "Prof. Dr. I. Chiricuta"
      • Iasi, Romania
        • Center of Medical Oncology
      • Sibiu, Romania
        • Emergency County Hospital Sibiu
      • Timisoara, Romania
        • Oncology Clinic "Oncomed"
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Dnepropetrovsk State Medical Acedamy
      • Kharkov, Ukraine
        • Institute of Medical Radiology of Acedamy of Medical Sciences
      • Kiev, Ukraine
        • Department of Abdominal Surgery
      • Kiev, Ukraine
        • Institut of Oncology
      • Kiev, Ukraine
        • Surgical Department
      • Rovno, Ukraine
        • Rivne Regional Oncological Dispensary
      • Sumy, Ukraine
        • Sumy Reginal Oncology Center
      • Uzhorod, Ukraine
        • Regional Clinical Oncological Dispensary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically proven triple-receptor-negative metastatic or relapsed breast cancer
  • Minimum interval of 6 months after the end of any previous taxane- containing chemotherapy regimen
  • At least one tumor lesion measurable according to RECIST criteria
  • Gender: female
  • Age >= 18 years old
  • Negative pregnancy test (females of childbearing potential)
  • Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment
  • ECOG performance status 0, 1 or 2
  • Signed informed consent

Exclusion Criteria:

  • More than 1 previous chemotherapeutic treatment for metastatic or relapsed disease
  • Major surgery < 4 weeks prior to enrollment
  • Immunotherapy < 2 weeks prior to enrollment
  • Severe pulmonary obstructive or restrictive disease
  • Uncontrolled inflammatory disease (autoimmune or infectious)
  • Clinically significant cardiac disease (NYHA stadium > 2)
  • Laboratory tests (hematology, chemistry) outside specified limits
  • Pregnancy or nursing status
  • Known positive HIV testing
  • Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations
  • History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
  • Known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study)
  • History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
EndoTAG-1 + Paclitaxel
Drug: EndoTAG-1 + paclitaxel
EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
Experimental: 2
EndoTAG-1
Drug: EndoTAG-1
EndoTAG-1 44 mg/m² twice weekly
Active Comparator: 3
Paclitaxel
Drug: Paclitaxel
Paclitaxel 90 mg/m² weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
4-month progression free survival (PFS) rate
Time Frame: 4 month
4 month

Secondary Outcome Measures

Outcome Measure
Time Frame
median progression free survival (PFS) time
Time Frame: progression of last patient
progression of last patient
tumor response
Time Frame: Last patient out
Last patient out
4-month survival rate
Time Frame: 4-month
4-month
median overall survival time
Time Frame: Withdrawal or death of last patient
Withdrawal or death of last patient
pain assessment
Time Frame: Last patient out
Last patient out
clinical benefit assessment via quality of life (QoL)Scale
Time Frame: Last patient out
Last patient out
adverse events
Time Frame: Last patient out
Last patient out
laboratory values
Time Frame: Last patient out
Last patient out
dose variations
Time Frame: Last patient out
Last patient out

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MediGene

Investigators

  • Principal Investigator: Ahmad Awada, Dr., Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 16, 2007

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 3, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT 4002
  • EudraCT-Nr. 2006-002221-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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