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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

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).

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: EndoTAG-1 + paclitaxel Drug: EndoTAG-1 Drug: Paclitaxel Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Study Start Date : January 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

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




Primary Outcome Measures :
  1. 4-month progression free survival (PFS) rate [ Time Frame: 4 month ]

Secondary Outcome Measures :
  1. median progression free survival (PFS) time [ Time Frame: progression of last patient ]
  2. tumor response [ Time Frame: Last patient out ]
  3. 4-month survival rate [ Time Frame: 4-month ]
  4. median overall survival time [ Time Frame: Withdrawal or death of last patient ]
  5. pain assessment [ Time Frame: Last patient out ]
  6. clinical benefit assessment via quality of life (QoL)Scale [ Time Frame: Last patient out ]
  7. adverse events [ Time Frame: Last patient out ]
  8. laboratory values [ Time Frame: Last patient out ]
  9. dose variations [ Time Frame: Last patient out ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448305


Locations
Show Show 33 study locations
Sponsors and Collaborators
MediGene
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MediGene
ClinicalTrials.gov Identifier: NCT00448305    
Other Study ID Numbers: CT 4002
EudraCT-Nr. 2006-002221-23
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012
Keywords provided by MediGene:
breast cancer
metastatic
relapsed
triple-receptor negative
EndoTAG-1
metastatic or relapsed breast neoplasm
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action