Breast CancerPhase 2NCT00600249
Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.
A Phase 2 study testing Cetuximab and Docetaxel in people with Breast Cancer, run by Centre Jean Perrin at 6 sites in France.
Trial summary
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux". Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cetuximab and Docetaxel
- How many people
- 35 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2008to May 2012
- 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
- § Age > or equal to 18 years.§
- Performance status inferior or equal to 1 (WHO criteria)
- Histologically proven breast cancer, non metastatic, with clinical tumor diameter > or equal to 2 cm.
- HR negative and HER 2 negative.
- Clinical stage II and IIIa.
- Non prior treated patients either by surgery, radiotherapy, hormonotherapy or chemotherapy.§
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- Adequate hematological, renal and hepatic functions : neutrophils > 2.109 /L, platelets > 100.109 /L, Hb > 10 g/dL, normal bilirubin, ASAT and ALAT inferior or equal to 2,5 ULN (upper normal limit), alkaline phosphatases £ 2,5 ULN, creatinine < 140 µmol/L or creatinine clearance > 60 mL/min.§
- Written informed consent§
- Affiliation with social security system (or profit being of such a mode) according to terms' of the law of August 9, 2004.
Who cannot join
- Male patient.
- Pregnant or lactating women or childbearing potential with no efficacy contraception.
- Other breast cancer form and particularly inflammatory form and/or negliged (T4b or T4d).§
- Non measurable tumor.
- Prior surgery or primary axillary dissection.
- Prior treatment for this new breast cancer.
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- Under guardianship patient
- Patient with antecedent of second cancer, excepted in situ uterine carcinoma or baso-cellular cutaneous cancer considered as definitively cured.
- Patient with an associated pathology considered incompatible with the study.§ Cardiac, renal, medullar, respiratory or hepatic insufficiency.
- Significant neurological or psychiatric troubles.§ Symptomatic or evolutive troubles in CNS or metastasis.
- Peripheral neuropathy > grade 2 NCI-CTC (version 3.0)
- Previous allergy with polysorbate 80.
- Concomitant treatment with a drug tested in a clinical trial, participation to another clinical study, for the last thirty days or prior chemotherapy.
- Patients non stable for the following 6 months or leaving at a great distance of the participating center.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Jean Perrin
Clermont-Ferrand, 63011
CHU Albert Michallon
Grenoble, 38043
Centre Oscar Lambret
Lille, 59020
Centre Hospitalier
Montluçon, 03113
Institut de Cancérologie de la LOIRE
Saint-Priest-en-Jarez, 42270
Hôpital Georges Pianta
Thonon-les-Bains, 74203
About this study
Official title: Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study.
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".
- Conditions
- Breast Cancer
- Keywords
- Breast cancer., Triple negative., Neoadjuvant chemotherapy., Targeted therapy.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response assessment of Taxotere-Erbitux combination
Measured: After 18 weeks of treatment
Secondary outcomes (1)
Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments
Measured: After 18 weeks of treatment, at surgery and at five years (survival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2012
- Study completionMay 2012
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 CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Sanofi
- Responsible party
- Sponsor
- Investigators
- Philippe Chollet, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600249
- Sponsor's protocol ID
- TENEO
- Status last verified
- Mar 2014
- First submitted
- 14 Jan 2008
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nabholtz JM, Chalabi N, Radosevic-Robin N, Dauplat MM, Mouret-Reynier MA, Van Praagh I, Servent V, Jacquin JP, Benmammar KE, Kullab S, Bahadoor MR, Kwiatkowski F, Cayre A, Abrial C, Durando X, Bignon YJ, Chollet P, Penault-Llorca F. Multicentric neoadjuvant pilot Phase II study of cetuximab combined with docetaxel in operable triple negative breast cancer. Int J Cancer. 2016 May 1;138(9):2274-80. doi: 10.1002/ijc.29952. Epub 2015 Dec 28.
PubMed 26649807
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study.
- ClinicalTrials.gov ID
- NCT00600249
- Acronym / sponsor ID
- TENEO
- Conditions
- Breast Cancer
- Keywords
- Breast cancer., Triple negative., Neoadjuvant chemotherapy., Targeted therapy.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Sanofi
- Study start
- Jan 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Jan 2008 (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 pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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)
- § Age > or equal to 18 years.§
- Performance status inferior or equal to 1 (WHO criteria)
- Histologically proven breast cancer, non metastatic, with clinical tumor diameter > or equal to 2 cm.
- HR negative and HER 2 negative.
- Clinical stage II and IIIa.
Key exclusion criteria (14 listed)
- Male patient.
- Pregnant or lactating women or childbearing potential with no efficacy contraception.
- Other breast cancer form and particularly inflammatory form and/or negliged (T4b or T4d).§
- Non measurable tumor.
- Prior surgery or primary axillary dissection.
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 |
|---|---|---|
| CetuximabAlso: Current sponsor code: EMD271786dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks | Drug | – |
| DocetaxelAlso: CAS: 148408-66-6100mg/m2 every 21 days 6 cycles of 21 days | Drug | – |
Primary outcome
Pathological complete response assessment of Taxotere-Erbitux combination
Time frame: After 18 weeks of treatment
1 secondary outcome
Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments
Time frame: After 18 weeks of treatment, at surgery and at five years (survival)
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 20 Mar 2014.
- Derived from this study: PubMed 26649807Nabholtz JM, Chalabi N, Radosevic-Robin N, Dauplat MM, Mouret-Reynier MA, Van Praagh I, Servent V, Jacquin JP, Benmammar KE, Kullab S, Bahadoor MR, Kwiatkowski F, Cayre A, Abrial C, Durando X, Bignon YJ, Chollet P, Penault-Llorca F. Multicentric neoadjuvant pilot Phase II study of cetuximab combined with docetaxel in operable triple negative breast cancer. Int J Cancer. 2016 May 1;138(9):2274-80. doi: 10.1002/ijc.29952. Epub 2015 Dec 28.
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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.
Philippe Chollet, MD principal investigator
Centre Jean Perrin
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab and Docetaxel in people with Breast Cancer, run by Centre Jean Perrin at 6 sites in France.
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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Pathological complete response assessment of Taxotere-Erbitux combination (time frame: After 18 weeks of treatment). 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 NCT00600249, 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 20 Mar 2014.