EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

Sponsor

MediGene (Industry)

Overall Status

Completed

CT.gov ID

NCT00448305

Collaborator

(none)

143

Enrollment

Locations

Arms

49.9

Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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)

Study Design

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

4-month progression free survival (PFS) rate [4 month]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles	Brussels	Belgium	1000
2	CHU Brugmann	Brussels	Belgium
3	UZ Antwerpen	Edegem	Belgium
4	CHU Liège	Liège	Belgium
5	Centre Oscar Lambret	Lille	France
6	Cente Antoine Lacassagne	Nice	France
7	Institut Curie	Paris	France
8	Hôpital de Jour Centre Henri Kaplan	Tours	France
9	Institut Gustave Roussy	Villejuif	France
10	Vedanta Institute of Medical Science	Ahmedabad	India
11	Bangalore Institute of Oncology	Bangalore	India
12	Searoc Cancer Center	Jaipur	India
13	Lakeshore Hospital	Kochin	India
14	Deenanath Mangeshkar Hospital	Pune	India
15	Kaushalya Medical Foundation	Thane	India
16	Wojewodzkie Centrum Onkologii	Gdansk	Poland
17	Centrum Onkologii Instytut im. M. Sklodowskiej-Curie	Gliwice	Poland
18	Instytut im. M. Sklodowskiej-Curie	Lublin	Poland
19	NZOZ Grupowa Specjalistyczna	Olsztyn	Poland
20	Klinika Onkologii Adadmii Medycznej	Poznan	Poland
21	Institute of Oncology "Prof. Dr. Al. Trestioreanu"	Bucharest	Romania
22	Institute of Oncology "Prof. Dr. I. Chiricuta"	Cluj Napoca	Romania
23	Center of Medical Oncology	Iasi	Romania
24	Emergency County Hospital Sibiu	Sibiu	Romania
25	Oncology Clinic "Oncomed"	Timisoara	Romania
26	Dnepropetrovsk State Medical Acedamy	Dnepropetrovsk	Ukraine
27	Institute of Medical Radiology of Acedamy of Medical Sciences	Kharkov	Ukraine
28	Department of Abdominal Surgery	Kiev	Ukraine
29	Institut of Oncology	Kiev	Ukraine
30	Surgical Department	Kiev	Ukraine
31	Rivne Regional Oncological Dispensary	Rovno	Ukraine
32	Sumy Reginal Oncology Center	Sumy	Ukraine
33	Regional Clinical Oncological Dispensary	Uzhorod	Ukraine

Sponsors and Collaborators

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