Breast CancerPhase 2AVATAXHERNCT01142778
A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer
A Phase 2 study testing Bevacizumab, Docetaxel and Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 28 sites in France.
Trial summary
This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. 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?
- Bevacizumab, Docetaxel and Trastuzumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 28 sitesFrance
- Study dates
- 19 May 2010to 13 Dec 2017
- 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
- Participants with early stage HER2-positive breast cancer
- Scheduled to receive neoadjuvant therapy with the objective of conservative surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Who cannot join
- Participants with partial or total lobular carcinoma
- Participants with inflammatory breast cancer
- Previous treatment with chemotherapy, radiation therapy or hormonal therapy for breast cancer
- Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in situ carcinoma of the cervix) relapsing within the 5 years before study entry or in situ contralateral breast carcinoma
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
Centre Radiotherapie Marie Curie
Arras, 62000
Centre Hospitalier; Hematologie-Oncologie
Beauvais, 60021
Clinique Tivoli; Sce Radiotherapie
Bordeaux, 33000
Hopital Augustin Morvan; Federation De Cancerologie
Brest, 29200
Centre Jean Perrin; Hopital De Jour
Clermont-Ferrand, 63011
Pole Sante Republique;Oncologie Hematologie
Clermont-Ferrand, 63050
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079
Institut Daniel Hollard
Grenoble, 38000
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925
Hopital Dupuytren; Oncologie Medicale
Limoges, 87042
Centre Leon Berard; Oncologie Genetique
Lyon, 69373
Hopital Clinique Claude Bernard; Oncologie Medicale
Metz, 57000
Ch De Montlucon; Sce Med Interne Hemato Onco
Montluçon, 03100
Institut régional du Cancer Montpellier
Montpellier, 34298
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189
Institut Curie; Oncologie Medicale
Paris, 75231
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris, 75674
HOPITAL TENON; Cancerologie Medicale
Paris, 75970
Clinique Francheville; Radiotherapie
Périgueux, 24000
Institut Jean Godinot; Oncologie Medicale
Reims, 51056
Centre Eugene Marquis; Unite Huguenin
Rennes, 35042
Clinique de L'Union; Oncologie
Saint-Jean, 31240
Institut de Cancerologie de La Loire; Radiotherapie
Saint-Priest-en-Jarez, 42271
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076
Centre Henry S Kaplan - CHU Bretonneau ; service oncologie
Tours, 37044
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54511
About this study
Official title: An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer
This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Docetaxel, Trastuzumab, Surgery, Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab at a dose of 15 mg/kg will be administered as IV infusion over 90 minutes from Cycles 3-6 (1 Cycle=21 days).
DocetaxelDrug
Also called Taxotere
Docetaxel at a dose of 100 mg/m^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).
TrastuzumabDrug
Also called Herceptin
Trastuzumab will be administered as a loading dose of 8 mg/kg as IV infusion in Cycle 1, followed by subsequent dose of 6 mg/kg as IV infusion in Cycles 2 to 7, and during additional 11 cycles post surgery (1 Cycle=21 days).
SurgeryProcedure or surgery
All participants will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the study treatment infusion in Cycle 6 (1 Cycle=21 days).
RadiotherapyRadiation
All participants will receive radiotherapy starting about 4 to 8 weeks after surgery, and will last around 4 to 6 weeks as per site's standard practice.
Hormonal TherapyDrug
Participants who are hormone receptors positive, will receive hormonal therapy after completion of radio therapy period as per investigator's discretion and site's standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab, Docetaxel, and Bevacizumab | Experimental | Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of <70% will receive trastuzumab and docetaxel along with bevacizumab in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the bevacizumab infusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. Receives: Drug: Bevacizumab; Drug: Docetaxel; Drug: Trastuzumab; Procedure: Surgery; Radiation: Radiotherapy; Drug: Hormonal Therapy |
| Trastuzumab and Docetaxel | Active comparator | Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of <70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. Receives: Drug: Docetaxel; Drug: Trastuzumab; Procedure: Surgery; Radiation: Radiotherapy; Drug: Hormonal Therapy |
| Trastuzumab and Docetaxel (Standard Regimen) | Active comparator | Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of >/=70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. Receives: Drug: Docetaxel; Drug: Trastuzumab; Procedure: Surgery; Radiation: Radiotherapy; Drug: Hormonal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Pathological Complete Response as per Chevallier's Classification as Reviewed by an Independent Committee
Measured: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Secondary outcomes (9)
Percentage of Participants With Pathological Complete Response According to Chevallier's Classification as per Local Procedures
Measured: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Pathological Complete Response According to Sataloff's Classification as Reviewed by an Independent Committee
Measured: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Ultrasound Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Neodajuvant treatment period (21 weeks)
Percentage of Participants With Conservative Surgery Post Neoadjuvant Treatment
Measured: Week 20 (between Day 28 and Day 35 after the Cycle 6, cycle length=21 days)
Local Relapse-Free Interval (LRFI) According to Modified RECIST Criteria
Measured: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Disease-Free Survival (DFS) According to Modified RECIST Criteria
Measured: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Distant Disease-Free Interval (DDFI) According to Modified RECIST Criteria
Measured: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Overall Survival
Measured: Baseline up to occurrence of death (up to 5 years)
Percentage of Participants With Adverse Events
Measured: Baseline up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study start19 May 2010
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
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.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142778
- Sponsor's protocol ID
- ML22229
- Other IDs
- 2009-013410-26, 2009
- Acronym
- AVATAXHER
- Status last verified
- Mar 2018
- First submitted
- 10 Jun 2010
- Last updated
- 16 Mar 2018
- Results posted
- No
Publications
Coudert B, Pierga JY, Mouret-Reynier MA, Kerrou K, Ferrero JM, Petit T, Kerbrat P, Dupre PF, Bachelot T, Gabelle P, Giard S, Coeffic D, Bougnoux P, Prevost JB, Paintaud G, Thibault G, Hernandez J, Coudert M, Arnould L, Berriolo-Riedinger A. Use of [(18)F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [(18)F]-FDG PET-predicted non-responders (AVATAXHER): an open-label, randomised phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1493-1502. doi: 10.1016/S1470-2045(14)70475-9. Epub 2014 Oct 30.
PubMed 25456368
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01142778
- Acronym / sponsor ID
- AVATAXHER / ML22229
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 19 May 2010 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 11 Jun 2010 (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.
This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab, Docetaxel, and Bevacizumab | Experimental | Drug: Bevacizumab, Drug: Docetaxel, Drug: Trastuzumab, Procedure: Surgery, Radiation: Radiotherapy, Drug: Hormonal TherapyParticipants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of <70% will receive trastuzumab and docetaxel along with bevacizumab in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the bevacizumab infusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. |
| Trastuzumab and Docetaxel | Active comparator | Drug: Docetaxel, Drug: Trastuzumab, Procedure: Surgery, Radiation: Radiotherapy, Drug: Hormonal TherapyParticipants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of <70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. |
| Trastuzumab and Docetaxel (Standard Regimen) | Active comparator | Drug: Docetaxel, Drug: Trastuzumab, Procedure: Surgery, Radiation: Radiotherapy, Drug: Hormonal TherapyParticipants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of >/=70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with early stage HER2-positive breast cancer
- Scheduled to receive neoadjuvant therapy with the objective of conservative surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Key exclusion criteria (4 listed)
- Participants with partial or total lobular carcinoma
- Participants with inflammatory breast cancer
- Previous treatment with chemotherapy, radiation therapy or hormonal therapy for breast cancer
- Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in situ carcinoma of the cervix) relapsing within the 5 years before study entry or in situ contralateral breast carcinoma
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 |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab at a dose of 15 mg/kg will be administered as IV infusion over 90 minutes from Cycles 3-6 (1 Cycle=21 days). | Drug | Trastuzumab, Docetaxel, and Bevacizumab |
| DocetaxelAlso: TaxotereDocetaxel at a dose of 100 mg/m^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days). | Drug | Trastuzumab and Docetaxel, Trastuzumab and Docetaxel (Standard Regimen), Trastuzumab, Docetaxel, and Bevacizumab |
| TrastuzumabAlso: HerceptinTrastuzumab will be administered as a loading dose of 8 mg/kg as IV infusion in Cycle 1, followed by subsequent dose of 6 mg/kg as IV infusion in Cycles 2 to 7, and during additional 11 cycles post surgery (1 Cycle=21 days). | Drug | Trastuzumab and Docetaxel, Trastuzumab and Docetaxel (Standard Regimen), Trastuzumab, Docetaxel, and Bevacizumab |
| SurgeryAll participants will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the study treatment infusion in Cycle 6 (1 Cycle=21 days). | Procedure or surgery | Trastuzumab and Docetaxel, Trastuzumab and Docetaxel (Standard Regimen), Trastuzumab, Docetaxel, and Bevacizumab |
| RadiotherapyAll participants will receive radiotherapy starting about 4 to 8 weeks after surgery, and will last around 4 to 6 weeks as per site's standard practice. | Radiation | Trastuzumab and Docetaxel, Trastuzumab and Docetaxel (Standard Regimen), Trastuzumab, Docetaxel, and Bevacizumab |
| Hormonal TherapyParticipants who are hormone receptors positive, will receive hormonal therapy after completion of radio therapy period as per investigator's discretion and site's standard practice. | Drug | Trastuzumab and Docetaxel, Trastuzumab and Docetaxel (Standard Regimen), Trastuzumab, Docetaxel, and Bevacizumab |
Primary outcome
Percentage of Participants With Pathological Complete Response as per Chevallier's Classification as Reviewed by an Independent Committee
Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
9 secondary outcomes
Percentage of Participants With Pathological Complete Response According to Chevallier's Classification as per Local Procedures
Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Pathological Complete Response According to Sataloff's Classification as Reviewed by an Independent Committee
Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Ultrasound Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Neodajuvant treatment period (21 weeks)
Percentage of Participants With Conservative Surgery Post Neoadjuvant Treatment
Time frame: Week 20 (between Day 28 and Day 35 after the Cycle 6, cycle length=21 days)
Local Relapse-Free Interval (LRFI) According to Modified RECIST Criteria
Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Disease-Free Survival (DFS) According to Modified RECIST Criteria
Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Distant Disease-Free Interval (DDFI) According to Modified RECIST Criteria
Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Overall Survival
Time frame: Baseline up to occurrence of death (up to 5 years)
Percentage of Participants With Adverse Events
Time frame: Baseline up to 5 years
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 16 Mar 2018.
- Derived from this study: PubMed 25456368Coudert B, Pierga JY, Mouret-Reynier MA, Kerrou K, Ferrero JM, Petit T, Kerbrat P, Dupre PF, Bachelot T, Gabelle P, Giard S, Coeffic D, Bougnoux P, Prevost JB, Paintaud G, Thibault G, Hernandez J, Coudert M, Arnould L, Berriolo-Riedinger A. Use of [(18)F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [(18)F]-FDG PET-predicted non-responders (AVATAXHER): an open-label, randomised phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1493-1502. doi: 10.1016/S1470-2045(14)70475-9. Epub 2014 Oct 30.
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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.
Clinical Trials study director
Hoffmann-La Roche
28 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 Bevacizumab, Docetaxel and Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 28 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 3 inclusion and 4 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 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
Percentage of Participants With Pathological Complete Response as per Chevallier's Classification as Reviewed by an Independent Committee (time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)). 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 NCT01142778, 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 16 Mar 2018.