Metastatic Breast CancerPhase 2NCT00524810
Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer
A Phase 2 study testing Pegylated liposomal doxorubicin and Docetaxel in people with Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Pegylated liposomal doxorubicin and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2004to Jun 2009
- 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
- first metastatic chemo line
- presence of measurable or bone lesion
- at least one lesion outside the radiated areas
- can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks
Who cannot join
- only local tumoral progression
- symptomatic cerebral metastasis
- neuropathy > NCI-CTC 2
- previous cancer within 10 years _ previous cancer within 10 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer
Read the detailed description
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Pegylated liposomal doxorubicin, 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.
Pegylated liposomal doxorubicinDrug
Also called Caelyx
Caelyx 30 mg/m² day 1 every 3 weeks
DocetaxelDrug
Also called Taxotere
Taxotere 75 mg/m² day 2 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Caelyx - Taxotere | Experimental | Not described Receives: Drug: Pegylated liposomal doxorubicin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-progression rate after 6 cycles
Measured: 6 months
Secondary outcomes (4)
tolerance and toxicity
Measured: 6 months
Tumor response and duration
Measured: 5 years
Time to Progression
Measured: 5 years
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startFeb 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Laure CHAUVENET, MD, PHD, Principal investigator, Hôpital HOTEL DIEU - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524810
- Sponsor's protocol ID
- CAPYTTOLE
- Status last verified
- Jun 2011
- First submitted
- 3 Sep 2007
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00524810
- Acronym / sponsor ID
- CAPYTTOLE
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Sep 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.
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer
Detailed description
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caelyx - Taxotere | Experimental | Drug: Pegylated liposomal doxorubicin, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first metastatic chemo line
- presence of measurable or bone lesion
- at least one lesion outside the radiated areas
- can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks
Key exclusion criteria (4 listed)
- only local tumoral progression
- symptomatic cerebral metastasis
- neuropathy > NCI-CTC 2
- previous cancer within 10 years _ previous cancer within 10 years
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 |
|---|---|---|
| Pegylated liposomal doxorubicinAlso: CaelyxCaelyx 30 mg/m² day 1 every 3 weeks | Drug | Caelyx - Taxotere |
| DocetaxelAlso: TaxotereTaxotere 75 mg/m² day 2 every 3 weeks | Drug | Caelyx - Taxotere |
Primary outcome
Non-progression rate after 6 cycles
Time frame: 6 months
4 secondary outcomes
tolerance and toxicity
Time frame: 6 months
Tumor response and duration
Time frame: 5 years
Time to Progression
Time frame: 5 years
Overall survival
Time frame: 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 30 Jun 2011.
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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.
Laure CHAUVENET, MD, PHD principal investigator
Hôpital HOTEL DIEU - Paris
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 Pegylated liposomal doxorubicin and Docetaxel in people with Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP 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 4 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 30 Jun 2011. 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?
Non-progression rate after 6 cycles (time frame: 6 months). 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 30 Jun 2011.