Clinical trial NCT00448305: EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast cancer
metastatic
relapsed
triple-receptor negative
EndoTAG-1
metastatic or relapsed breast neoplasm
Lead sponsor: MediGene
Sponsor class: INDUSTRY
First posted: 2007-03-16
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: 4-month progression free survival (PFS) rate
timeFrame: 4 month
Secondary outcomes:
measure: median progression free survival (PFS) time
timeFrame: progression of last patient
measure: tumor response
timeFrame: Last patient out
measure: 4-month survival rate
timeFrame: 4-month
measure: median overall survival time
timeFrame: Withdrawal or death of last patient
measure: pain assessment
timeFrame: Last patient out
measure: clinical benefit assessment via quality of life (QoL)Scale
timeFrame: Last patient out
measure: adverse events
timeFrame: Last patient out
measure: laboratory values
timeFrame: Last patient out
measure: dose variations
timeFrame: Last patient out
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Liège
country: Belgium
facility: CHU Liège
city: Lille
country: France
facility: Centre Oscar Lambret
city: Nice
country: France
facility: Cente Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Tours
country: France
facility: Hôpital de Jour Centre Henri Kaplan
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Ahmedabad
country: India
facility: Vedanta Institute of Medical Science
city: Bangalore
country: India
facility: Bangalore Institute of Oncology
city: Jaipur
country: India
facility: Searoc Cancer Center
city: Kochin
country: India
facility: Lakeshore Hospital
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
city: Thane
country: India
facility: Kaushalya Medical Foundation
city: Gdansk
country: Poland
facility: Wojewodzkie Centrum Onkologii
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
city: Lublin
country: Poland
facility: Instytut im. M. Sklodowskiej-Curie
city: Olsztyn
country: Poland
facility: NZOZ Grupowa Specjalistyczna
city: Poznan
country: Poland
facility: Klinika Onkologii Adadmii Medycznej
city: Bucharest
country: Romania
facility: Institute of Oncology "Prof. Dr. Al. Trestioreanu"
city: Cluj Napoca
country: Romania
facility: Institute of Oncology "Prof. Dr. I. Chiricuta"
city: Iasi
country: Romania
facility: Center of Medical Oncology
city: Sibiu
country: Romania
facility: Emergency County Hospital Sibiu
city: Timisoara
country: Romania
facility: Oncology Clinic "Oncomed"
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk State Medical Acedamy
city: Kharkov
country: Ukraine
facility: Institute of Medical Radiology of Acedamy of Medical Sciences
city: Kiev
country: Ukraine
facility: Department of Abdominal Surgery
city: Kiev
country: Ukraine
facility: Institut of Oncology
city: Kiev
country: Ukraine
facility: Surgical Department
city: Rovno
country: Ukraine
facility: Rivne Regional Oncological Dispensary
city: Sumy
country: Ukraine
facility: Sumy Reginal Oncology Center
city: Uzhorod
country: Ukraine
facility: Regional Clinical Oncological Dispensary
Study officials:
affiliation: Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium
name: Ahmad Awada, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.