Breast NeoplasmsPhase 2NCT00617968
GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer
A Phase 2 study testing DOCETAXEL in people with Breast Neoplasms, run by Sanofi at 1 site in France.
Trial summary
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- DOCETAXEL
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2003to Jun 2005
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with breast cancer histologically proven by microbiopsy (14G or 16G) enabling confirmation of the diagnosis, and evaluation of the histological prognostic grade, hormonal receptors and HER2 status.
- Tumor T2 or T3, non-metastasized, non-inflammatory, unilateral
- Clinically or radiologically measurable lesion greater than 2 cm (ultrasound and/or mammogram)
- Receptors RE+ and/or RP+ (positive status determined according to the criteria of the investigating centers)
- HER 2 / neu status of 0, 1+ or 2+ in immunohistochemistry
- Histological grade I or II
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- Menopausal patients aged greater than or equal to 60 years
- Patients with ECOG PS greater than or equal to 2
- Satisfactory hematological, hepatic and renal functions:
- Hemoglobin greater than or equal to 10 g/dL
- Platelet count greater than or equal to 100x109/L
- Polynuclear neutrophil count greater than 1.5x109/L
- Creatinine less than or equal to ≤ 1.5 ULN
- AST/ALT less than or equal to 1.5 ULN
- Alkaline phosphatases less than or equal to 2.5 ULN
- Patients able to be followed throughout the study
- Patient's consent obtained.
Who cannot join
- Inflammatory or T4 breast cancer
- T1 tumor
- Patients whose tumor is deemed by the doctor to be difficult to evaluate
- Tumor that is metastatic from the outset (M1) or locally advanced and inoperable from the outset
- RE and RP receptors negative or unknown
- HER 2/neu positive at 3 +
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- Non-menopausal patients
- Surgical biopsy and/or ganglion dissection before neoadjuvant treatment
- Significant poorly controlled cardiac disorders, such as unstable angina pectoris, poorly controlled heart failure, arrhythmia requiring treatment, or myocardial infarction within the last 3 months
- Cardiovascular, hepatic, neurological or endocrine disease, or other major systemic disease that makes it difficult to conduct the protocol or to interpret the results
- Previous history of cancer that occurred within the last 10 years, with the exception of cervical cancers and basocellular skin cancers that were properly treated
- Allergy to polysorbate 80
- Hypersensitivity to docetaxel
- Participation in another clinical trial with one of the study medicinal products during the 30 days prior to entry in the study
- Patients who are unable to undergo medical monitoring for geographical, social or psychological reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.
- Conditions
- Breast Neoplasms
- Being tested
- DOCETAXEL
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOCETAXELDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical and radiological response evaluated according to RECIST criteria
Measured: During the study conduct
Secondary outcomes (1)
Rate of histological response
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startOct 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathalie BILLON, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617968
- Sponsor's protocol ID
- XRP6976D_2502
- Status last verified
- Sep 2009
- First submitted
- 6 Feb 2008
- Last updated
- 2 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.
- ClinicalTrials.gov ID
- NCT00617968
- Acronym / sponsor ID
- XRP6976D_2502
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Jun 2005 (actual)
- First posted
- 18 Feb 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.
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female patients with breast cancer histologically proven by microbiopsy (14G or 16G) enabling confirmation of the diagnosis, and evaluation of the histological prognostic grade, hormonal receptors and HER2 status.
- Tumor T2 or T3, non-metastasized, non-inflammatory, unilateral
- Clinically or radiologically measurable lesion greater than 2 cm (ultrasound and/or mammogram)
- Receptors RE+ and/or RP+ (positive status determined according to the criteria of the investigating centers)
- HER 2 / neu status of 0, 1+ or 2+ in immunohistochemistry
Key exclusion criteria (15 listed)
- Inflammatory or T4 breast cancer
- T1 tumor
- Patients whose tumor is deemed by the doctor to be difficult to evaluate
- Tumor that is metastatic from the outset (M1) or locally advanced and inoperable from the outset
- RE and RP receptors negative or unknown
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 |
|---|---|---|
| DOCETAXEL | Drug | – |
Primary outcome
Rate of clinical and radiological response evaluated according to RECIST criteria
Time frame: During the study conduct
1 secondary outcome
Rate of histological response
Time frame: During the study conduct
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 2 Sep 2009.
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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.
Nathalie BILLON study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DOCETAXEL in people with Breast Neoplasms, run by Sanofi at 1 site 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 17 inclusion and 15 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 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of clinical and radiological response evaluated according to RECIST criteria (time frame: During the study conduct). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2009.