EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448305
• Other study ID #: CT 4002
• Secondary ID: EudraCT-Nr. 2006
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: January 3, 2012
• Start date: January 2007
• Est. completion date: March 2011

Study information

• Verified date: January 2012
• Source: MediGene
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• EndoTAG-1 + paclitaxel
EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
• EndoTAG-1
EndoTAG-1 44 mg/m² twice weekly
• Paclitaxel
Paclitaxel 90 mg/m² weekly

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MediGene

Countries where clinical trial is conducted

Belgium,  France,  India,  Poland,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-month progression free survival (PFS) rate		4 month	No
Secondary	median progression free survival (PFS) time		progression of last patient	No
Secondary	tumor response		Last patient out	No
Secondary	4-month survival rate		4-month	No
Secondary	median overall survival time		Withdrawal or death of last patient	No
Secondary	pain assessment		Last patient out	No
Secondary	clinical benefit assessment via quality of life (QoL)Scale		Last patient out	No
Secondary	adverse events		Last patient out	Yes
Secondary	laboratory values		Last patient out	Yes
Secondary	dose variations		Last patient out	Yes