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Angiogenesis Inhibitor
Chemotherapy + Targeted Therapy for Breast Cancer
Phase 2
Waitlist Available
Led By Rita Mehta, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Woman age ≥ 18
Known HER2 status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a combination of drugs is effective and has few side effects when given before surgery to people with HER2-positive or HER2-negative breast cancer.
Who is the study for?
This trial is for women over 18 with breast cancer, who have a performance status of 0-2 and normal heart function. HER2 positive patients receive carboplatin, paclitaxel, pertuzumab, and trastuzumab; HER2 negative get bevacizumab instead. Exclusions include men, pregnant/nursing women not using contraception, unhealed wounds, allergies to treatments, significant heart conditions or bleeding risks.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of combining chemotherapy drugs (carboplatin and paclitaxel) with targeted therapies (pertuzumab and trastuzumab for HER2 positive or bevacizumab for HER2 negative) in treating early-stage breast cancer before surgery.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medications used; nerve damage causing sensory changes; increased risk of infection due to lowered white blood cell counts; potential heart problems; fatigue from anemia caused by low red blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 or older.
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I know my cancer's HER2 status.
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I am able to get out of my bed or chair and move around.
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My breast cancer is of the inflammatory type.
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My tumor is at least 1 cm big or I have cancer in my lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-year progression free survival in patients treated with weekly carboplatin and paclitaxel combined with either trastuzumab and pertuzumab for HER2-positive patients or bevacizumab for HER2-negative patients in the neoadjuvant setting
Secondary outcome measures
Clinical complete response rates
Number of toxicities in Carboplatin+Paclitaxel+Bevacizumab (HER2) arm
Number of toxicities in Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)Experimental Treatment4 Interventions
Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Trastuzumab weekly 12 doses Pertuzumab every 3 weeks, 4 doses
Group II: Carboplatin+Paclitaxel+Bevacizumab (HER2-)Experimental Treatment3 Interventions
Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Bevacizumab every other week, 5 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved
Pertuzumab
FDA approved
Trastuzumab
FDA approved
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,881 Total Patients Enrolled
13 Trials studying Breast Cancer
2,120 Patients Enrolled for Breast Cancer
Rita Mehta, MDPrincipal InvestigatorUniversity of California, Irvine
4 Previous Clinical Trials
110 Total Patients Enrolled
2 Trials studying Breast Cancer
68 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition, such as heart failure or angina.I am not pregnant or nursing and agree to use contraception during and for a month after treatment.- Your blood counts need to be in a certain range.
- Your liver and kidney function tests need to be within normal limits.
- Women capable of getting pregnant need to have a negative pregnancy test within 14 days before starting the trial.My blood counts are low, increasing my risk for severe bleeding.I am a woman aged 18 or older.I know my cancer's HER2 status.My heart function is normal, confirmed by a test within the last 3 months.I am a male.I have wounds that are not fully healed.My breast cancer is confirmed by tissue analysis and can be in one or both breasts.I am able to get out of my bed or chair and move around.I am currently experiencing significant bleeding.My breast cancer is of the inflammatory type.My tumor is at least 1 cm big or I have cancer in my lymph nodes.I have nerve damage that limits my daily activities.My cancer has spread to distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Carboplatin+Paclitaxel+Bevacizumab (HER2-)
- Group 2: Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Could you please tell me what other research has been conducted on Paclitaxel?
"As of right now, there are 1656 ongoing studies involving Paclitaxel. Of these, 442 trials have reached Phase 3 status. Most investigations into Paclitaxel's efficacy are taking place in Seattle, but there are 86768 total trial locations worldwide."
Answered by AI
What is the most common use for Paclitaxel?
"While cyclophosphamide is often treated with Paclitaxel, this medication can also be used to effectively manage other conditions like lymphoma, non-hodgkin, recurrent cervical cancer, and locally advanced non-small cell lung cancer."
Answered by AI
Are people still being signed up for this research project?
"The clinicaltrials.gov website provides information that this study is open for enrollment and currently recruiting patients. This particular trial was posted on April 1st, 2015 with the most recent update being on April 15th, 2021. The research team is seeking a total of 120 individuals from one location to participate in this study."
Answered by AI
Is there a limit to how many people can join this clinical trial?
"Yes, the information on clinicaltrials.gov confirms that this trial is currently searching for patients. The original posting date was April 1st, 2015 and the most recent update was on April 15th, 2021. The study plans to enroll 120 patients at a single location."
Answered by AI
Has Paclitaxel been federally sanctioned for clinical use?
"Paclitaxel is a Phase 2 medication, meaning that while there is some evidence supporting its safety, there is no data to suggest that it is effective. We rated Paclitaxel's safety as a 2."
Answered by AI
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