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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
Must not have
Known or suspected congestive heart failure, angina pectoris requiring antianginal medication, or other clinically significant cardiac condition.
Bone marrow depression or hematologic parameters in the range that would increase the risk for severe bleeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious heart condition, such as heart failure or angina.
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My blood counts are low, increasing my risk for severe bleeding.
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I am a male.
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I have wounds that are not fully healed.
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I am currently experiencing significant bleeding.
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I have nerve damage that limits my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Clinical complete response rates
Number of toxicities in Carboplatin+Paclitaxel+Bevacizumab (HER2) arm
Number of toxicities in Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)
+1 more

Awards & Highlights

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.

Trial 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
Carboplatin
FDA approved
Paclitaxel
FDA approved
Bevacizumab
FDA approved
Trastuzumab
FDA approved
Pertuzumab
FDA approved

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,932,928 Total Patients Enrolled
14 Trials studying Breast Cancer
2,154 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

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02436993 — Phase 2
Breast Cancer Research Study Groups: Carboplatin+Paclitaxel+Bevacizumab (HER2-), Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)
Breast Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02436993 — Phase 2
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02436993 — Phase 2
~5 spots leftby Jun 2025
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