Chemotherapy + Targeted Therapy for Breast Cancer

Palo Alto (17 mi)

Overseen byRita Mehta, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, Irvine

Stay on your current meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this phase II is to study the efficacy and toxicity of carboplatin and paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast cancer.

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 18 or older.

I know my cancer's HER2 status.

I am able to get out of my bed or chair and move around.

My breast cancer is of the inflammatory type.

My tumor is at least 1 cm big or I have cancer in my lymph nodes.

Exclusion Criteria

I have a serious heart condition, such as heart failure or angina.

My blood counts are low, increasing my risk for severe bleeding.

I am a male.

I have wounds that are not fully healed.

I am currently experiencing significant bleeding.

I have nerve damage that limits my daily activities.

Treatment Details

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.

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

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺 Approved in European Union as Avastin for: