Ductal CarcinomaPhase 2NCT00461344
Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer
A Phase 2 study testing Docetaxel and Doxorubicin in people with Ductal Carcinoma, run by Sanofi.
Trial summary
Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer Secondary: Clinical response rate To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer Type of surgery… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ductal Carcinoma
- What is being tested?
- Docetaxel and Doxorubicin
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Aug 2007
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified breast cancer
- Large (≥ 3 cm) breast cancer
- IIb-IIIa stage
- ECOG (Eastern Cooperative Oncology Group) status: 0-1-2
- Adequate bone marrow reserve: (Haemoglobin ≥ 12g/l, Absolute Neutrophil Count (ANC) ≥ 2.0x 10^9, Platelets ≥100 000)
- Laboratory results:
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- Bilirubin ≤ Upper Limit Normal (ULN)
- Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 ULN, Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 ULN,
- Alk.phosph. ≤ 5.0 ULN,
- Creatinin ≤ ULN, if borderline calculated at ≤ 60ml/min
- Normal cardiac function (the result of Left Ventricular Ejection Function (LVEF) must be above the lower limit of normal for the institution)
- Negative pregnancy test
- Hormonal receptor status assessed
Who cannot join
- Pregnancy or lactation
- SGOT and/or SGPT > 1.5 upper limit normal, associated with Alk.phosph > 2.5 ULN
- Serious medical condition including but not limited to:
- Uncontrolled hypertension
- Active ulcus pepticum
- Non-stable diabetes mellitus
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- Other contraindication of steroid treatment
- Myocardial infarction within the last 6 months prior study entry
- Significant neurologic/psychiatric disorders
- Active infection
- Peripheral neuropathy grade ≥ 2
- Unstable angina
- Severe arrhythmia
- Participation in other clinical trial
- Prior surgery, chemotherapy, hormonotherapy for breast cancer
- Past or current history of neoplasm other than breast cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 7 years
- History of hypersensitivity to the investigational products or to drugs with similar chemical structures
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- Treatment with any investigational product in the last 1 month before study entry.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel + Anthracycline x 4 Cycles Followed by Docetaxel Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed ≥ 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®- Based Chemotherapy
Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
Secondary:
- Clinical response rate
- To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer
- Type of surgery (radical/conservative)
- Conditions
- Ductal Carcinoma
- Being tested
- Docetaxel, Doxorubicin
- Keywords
- Breast
- Medical subject headings
- Carcinoma, Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
DoxorubicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
Secondary outcomes (1)
Secondary: 1. Clinical response rate 2. to investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer 3. Type of surgery (radical/conservative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startJul 2004
- Primary completionJun 2005
- Study completionAug 2007
Why it stopped: due to slow recruitment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal CarcinomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- László Erős, Study director, sanofi-aventis Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461344
- Sponsor's protocol ID
- XRP6976D_2504
- Status last verified
- Apr 2008
- First submitted
- 17 Apr 2007
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel + Anthracycline x 4 Cycles Followed by Docetaxel Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed ≥ 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®- Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00461344
- Acronym / sponsor ID
- XRP6976D_2504
- Conditions
- Ductal Carcinoma
- Keywords
- Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow recruitment of patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 18 Apr 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.
Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
Secondary:
- Clinical response rate
- To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer
- Type of surgery (radical/conservative)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically verified breast cancer
- Large (≥ 3 cm) breast cancer
- IIb-IIIa stage
- ECOG (Eastern Cooperative Oncology Group) status: 0-1-2
- Adequate bone marrow reserve: (Haemoglobin ≥ 12g/l, Absolute Neutrophil Count (ANC) ≥ 2.0x 10^9, Platelets ≥100 000)
Key exclusion criteria (20 listed)
- Pregnancy or lactation
- SGOT and/or SGPT > 1.5 upper limit normal, associated with Alk.phosph > 2.5 ULN
- Serious medical condition including but not limited to:
- Uncontrolled hypertension
- Active ulcus pepticum
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 | – |
| Doxorubicin | Drug | – |
Primary outcome
Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
1 secondary outcome
Secondary: 1. Clinical response rate 2. to investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer 3. Type of surgery (radical/conservative)
Results and safety
The study was stopped early (reason given: due to slow recruitment of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
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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.
László Erős study director
sanofi-aventis Hungary
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Doxorubicin in people with Ductal Carcinoma, run by Sanofi.
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 13 inclusion and 20 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: stopped early, as of the sponsor's last update on 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: due to slow recruitment of patients). Results are not available in the source record.
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?
Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer. 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 3 Apr 2008.