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EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00448305
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):
MediGene

Tracking Information
First Submitted Date  ICMJE March 15, 2007
First Posted Date  ICMJE March 16, 2007
Last Update Posted Date January 5, 2012
Study Start Date  ICMJE January 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
4-month progression free survival (PFS) rate [ Time Frame: 4 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2007)
4-month progression free survival (PFS) rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
  • median progression free survival (PFS) time [ Time Frame: progression of last patient ]
  • tumor response [ Time Frame: Last patient out ]
  • 4-month survival rate [ Time Frame: 4-month ]
  • median overall survival time [ Time Frame: Withdrawal or death of last patient ]
  • pain assessment [ Time Frame: Last patient out ]
  • clinical benefit assessment via quality of life (QoL)Scale [ Time Frame: Last patient out ]
  • adverse events [ Time Frame: Last patient out ]
  • laboratory values [ Time Frame: Last patient out ]
  • dose variations [ Time Frame: Last patient out ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2007)
  • median progression free survival (PFS) time
  • tumor response
  • 4-month survival rate
  • median overall survival time
  • pain assessment
  • clinical benefit assessment via quality of life (QoL)Scale
  • adverse events
  • laboratory values
  • dose variations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Official Title  ICMJE An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: EndoTAG-1 + paclitaxel
    EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
  • Drug: EndoTAG-1
    EndoTAG-1 44 mg/m² twice weekly
  • Drug: Paclitaxel
    Paclitaxel 90 mg/m² weekly
Study Arms  ICMJE
  • Experimental: 1
    EndoTAG-1 + Paclitaxel
    Intervention: Drug: EndoTAG-1 + paclitaxel
  • Experimental: 2
    EndoTAG-1
    Intervention: Drug: EndoTAG-1
  • Active Comparator: 3
    Paclitaxel
    Intervention: Drug: Paclitaxel
Publications * Awada A, Bondarenko IN, Bonneterre J, Nowara E, Ferrero JM, Bakshi AV, Wilke C, Piccart M; CT4002 study group. A randomized controlled phase II trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (TNBC). Ann Oncol. 2014 Apr;25(4):824-831. doi: 10.1093/annonc/mdu025.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2010)
143
Original Enrollment  ICMJE
 (submitted: March 15, 2007)
135
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   India,   Poland,   Romania,   Ukraine
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT00448305
Other Study ID Numbers  ICMJE CT 4002
EudraCT-Nr. 2006-002221-23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MediGene
Study Sponsor  ICMJE MediGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmad Awada, Dr. Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium
PRS Account MediGene
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP