NCT00448305

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
6 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

3.1 years

First QC Date

March 15, 2007

Last Update Submit

January 3, 2012

Conditions

Breast Neoplasms

Keywords

breast cancermetastaticrelapsedtriple-receptor negativeEndoTAG-1metastatic or relapsed breast neoplasm

Outcome Measures

Primary Outcomes (1)

  • 4-month progression free survival (PFS) rate

    4 month

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

EndoTAG-1 + Paclitaxel

Drug: EndoTAG-1 + paclitaxel

2

EXPERIMENTAL

EndoTAG-1

Drug: EndoTAG-1

3

ACTIVE COMPARATOR

Paclitaxel

Drug: Paclitaxel

Interventions

EndoTAG-1 + paclitaxelDRUG

EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly

1
EndoTAG-1DRUG

EndoTAG-1 44 mg/m² twice weekly

2
PaclitaxelDRUG

Paclitaxel 90 mg/m² weekly

3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, Belgium

Location

UZ Antwerpen

Edegem, Belgium

Location

CHU Liège

Liège, Belgium

Location

Centre Oscar Lambret

Lille, France

Location

Cente Antoine Lacassagne

Nice, France

Location

Institut Curie

Paris, France

Location

Hôpital de Jour Centre Henri Kaplan

Tours, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Vedanta Institute of Medical Science

Ahmedabad, India

Location

Bangalore Institute of Oncology

Bangalore, India

Location

Searoc Cancer Center

Jaipur, India

Location

Lakeshore Hospital

Kochi, India

Location

Deenanath Mangeshkar Hospital

Pune, India

Location

Kaushalya Medical Foundation

Thane, India

Location

Wojewodzkie Centrum Onkologii

Gdansk, Poland

Location

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Gliwice, Poland

Location

Instytut im. M. Sklodowskiej-Curie

Lublin, Poland

Location

NZOZ Grupowa Specjalistyczna

Olsztyn, Poland

Location

Klinika Onkologii Adadmii Medycznej

Poznan, Poland

Location

Institute of Oncology "Prof. Dr. Al. Trestioreanu"

Bucharest, Romania

Location

Institute of Oncology "Prof. Dr. I. Chiricuta"

Cluj-Napoca, Romania

Location

Center of Medical Oncology

Iași, Romania

Location

Emergency County Hospital Sibiu

Sibiu, Romania

Location

Oncology Clinic "Oncomed"

Timișoara, Romania

Location

Dnepropetrovsk State Medical Acedamy

Dnipro, Ukraine

Location

Institute of Medical Radiology of Acedamy of Medical Sciences

Kharkiv, Ukraine

Location

Department of Abdominal Surgery

Kiev, Ukraine

Location

Institut of Oncology

Kiev, Ukraine

Location

Surgical Department

Kiev, Ukraine

Location

Rivne Regional Oncological Dispensary

Rivne, Ukraine

Location

Sumy Reginal Oncology Center

Sumy, Ukraine

Location

Regional Clinical Oncological Dispensary

Uzhhorod, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 24667715DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm MetastasisRecurrence

Interventions

MBT-0206Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Ahmad Awada, Dr.

    Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 16, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2010

Study Completion

March 1, 2011

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

RO(5)UA(8)BE(4)FR(5)IN(6)PL(5)