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Anti-tumor antibiotic
Myocet for Breast Cancer
Phase 3
Waitlist Available
Led By Jose Baselga, M.D.
Research Sponsored by Sopherion Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior chemotherapy for metastatic disease
Measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs for treating HER2+ breast cancer.
Who is the study for?
This trial is for individuals with metastatic HER2+ breast cancer confirmed by FISH analysis, who have measurable disease and normal heart function. It's not open to those who've had certain past treatments like doxorubicin or epirubicin beyond specific doses, or relapsed within a year after completing similar therapies.Check my eligibility
What is being tested?
The study tests the effectiveness of adding Myocet to the standard treatment combo of paclitaxel and trastuzumab for first-time treatment in metastatic HER2+ breast cancer patients. One group will receive all three drugs, while another will get only paclitaxel and trastuzumab.See study design
What are the potential side effects?
Potential side effects include heart problems due to Myocet (similar to other anthracycline drugs), allergic reactions, lowered blood cell counts leading to increased infection risk, fatigue, hair loss, nausea and muscle pain from chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had chemotherapy for cancer that has spread.
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My cancer can be measured by tests.
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My heart pumps blood normally.
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My breast cancer has spread and is HER2 positive by FISH analysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival
Secondary outcome measures
Overall Survival
Safety
Find a Location
Who is running the clinical trial?
Sopherion TherapeuticsLead Sponsor
Jose Baselga, M.D.Principal InvestigatorVall d'Hebron Hospital, Barcelona, Spain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy for cancer that has spread.My cancer can be measured by tests.I have received more than the maximum allowed dose of doxorubicin or epirubicin.My cancer returned within a year after finishing treatment with trastuzumab, taxane, or anthracycline.My heart pumps blood normally.My breast cancer has spread and is HER2 positive by FISH analysis.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this medication been officially sanctioned by the FDA?
"This treatment's safety has been well-documented in prior Phase 3 trials, and it thus received a score of 3."
Answered by AI
Are investigators still searching for participants for this research project?
"Unfortunately, this particular clinical trial is not currently looking for new participants. According to the information available on clinicaltrials.gov, the study was posted on 1/1/2006 and was last updated over 10 years ago on 3/30/2009. However, there are 2,695 other trials that are enrolling patients right now."
Answered by AI
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