Breast NeoplasmsPhase 2NCT00448305
EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
A Phase 2 study testing EndoTAG-1 + paclitaxel, EndoTAG-1 and Paclitaxel in people with Breast Neoplasms, run by MediGene at 33 sites in 6 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- EndoTAG-1 + paclitaxel, EndoTAG-1 and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Jan 2007to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
Ukraine8 sites
Dnepropetrovsk State Medical Acedamy
Dnipro
Institute of Medical Radiology of Acedamy of Medical Sciences
Kharkiv
Department of Abdominal Surgery
Kiev
Institut of Oncology
Kiev
Surgical Department
Kiev
Rivne Regional Oncological Dispensary
Rivne
Sumy Reginal Oncology Center
Sumy
Regional Clinical Oncological Dispensary
Uzhhorod
India6 sites
Vedanta Institute of Medical Science
Ahmedabad
Bangalore Institute of Oncology
Bangalore
Searoc Cancer Center
Jaipur
Lakeshore Hospital
Kochi
Deenanath Mangeshkar Hospital
Pune
Kaushalya Medical Foundation
Thane
France5 sites
Centre Oscar Lambret
Lille
Cente Antoine Lacassagne
Nice
Institut Curie
Paris
Hôpital de Jour Centre Henri Kaplan
Tours
Institut Gustave Roussy
Villejuif
Poland5 sites
Wojewodzkie Centrum Onkologii
Gdansk
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Gliwice
Instytut im. M. Sklodowskiej-Curie
Lublin
NZOZ Grupowa Specjalistyczna
Olsztyn
Klinika Onkologii Adadmii Medycznej
Poznan
Romania5 sites
Institute of Oncology "Prof. Dr. Al. Trestioreanu"
Bucharest
Institute of Oncology "Prof. Dr. I. Chiricuta"
Cluj-Napoca
Center of Medical Oncology
Iași
Emergency County Hospital Sibiu
Sibiu
Oncology Clinic "Oncomed"
Timișoara
Belgium4 sites
Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles
Brussels, 1000
CHU Brugmann
Brussels
UZ Antwerpen
Edegem
CHU Liège
Liège
About this study
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
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).
Read the 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)
- Conditions
- Breast Neoplasms
- Being tested
- EndoTAG-1 + paclitaxel, EndoTAG-1, Paclitaxel
- Keywords
- breast cancer, metastatic, relapsed, triple-receptor negative, EndoTAG-1, metastatic or relapsed breast neoplasm
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoTAG-1 + paclitaxelDrug
EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly
EndoTAG-1Drug
EndoTAG-1 44 mg/m² twice weekly
PaclitaxelDrug
Paclitaxel 90 mg/m² weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | EndoTAG-1 + Paclitaxel Receives: Drug: EndoTAG-1 + paclitaxel |
| 2 | Experimental | EndoTAG-1 Receives: Drug: EndoTAG-1 |
| 3 | Active comparator | Paclitaxel Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-month progression free survival (PFS) rate
Measured: 4 month
Secondary outcomes (9)
median progression free survival (PFS) time
Measured: progression of last patient
tumor response
Measured: Last patient out
4-month survival rate
Measured: 4-month
median overall survival time
Measured: Withdrawal or death of last patient
pain assessment
Measured: Last patient out
clinical benefit assessment via quality of life (QoL)Scale
Measured: Last patient out
adverse events
Measured: Last patient out
laboratory values
Measured: Last patient out
dose variations
Measured: Last patient out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmad Awada, Dr., Principal investigator, Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448305
- Sponsor's protocol ID
- CT 4002
- Other IDs
- EudraCT-Nr. 2006-002221-23
- Status last verified
- Jan 2012
- First submitted
- 15 Mar 2007
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24667715
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00448305
- Acronym / sponsor ID
- CT 4002
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, metastatic, relapsed, triple-receptor negative, EndoTAG-1, metastatic or relapsed breast neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EndoTAG-1 + paclitaxelEndoTAG-1 + Paclitaxel |
| 2 | Experimental | Drug: EndoTAG-1EndoTAG-1 |
| 3 | Active comparator | Drug: PaclitaxelPaclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoTAG-1 + paclitaxelEndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly | Drug | 1 |
| EndoTAG-1EndoTAG-1 44 mg/m² twice weekly | Drug | 2 |
| PaclitaxelPaclitaxel 90 mg/m² weekly | Drug | 3 |
Primary outcome
4-month progression free survival (PFS) rate
Time frame: 4 month
9 secondary outcomes
median progression free survival (PFS) time
Time frame: progression of last patient
tumor response
Time frame: Last patient out
4-month survival rate
Time frame: 4-month
median overall survival time
Time frame: Withdrawal or death of last patient
pain assessment
Time frame: Last patient out
clinical benefit assessment via quality of life (QoL)Scale
Time frame: Last patient out
adverse events
Time frame: Last patient out
laboratory values
Time frame: Last patient out
dose variations
Time frame: Last patient out
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Derived from this study: PubMed 24667715Awada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Awada, Dr. principal investigator
Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EndoTAG-1 + paclitaxel, EndoTAG-1 and Paclitaxel in people with Breast Neoplasms, run by MediGene at 33 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Ukraine, India, France, Poland, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-month progression free survival (PFS) rate (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.