HER2-targeted Therapy + Immunotherapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Heather McArthur, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-K), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-K) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are \> 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.

Research Team

Heather McArthur, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults with untreated, non-metastatic HER2-positive breast cancer that's larger than 2 cm or has spread to lymph nodes. Participants must have good organ function and performance status, not be pregnant or breastfeeding, agree to use contraception, and provide a tumor tissue sample. Exclusions include prior treatments affecting the immune system, recent vaccines, active infections like HIV/Hepatitis/TB, other cancers within 3 years, significant heart disease or mental health issues.

Inclusion Criteria

My cancer has not spread to distant parts of my body and has not been treated yet.

I am 18 years old or older.

I can provide a sample of my tumor for testing.

Exclusion Criteria

I have had or currently have lung inflammation treated with steroids.

I have an autoimmune disease treated with medication in the last 2 years.

I have an immune system disorder or I am on long-term steroids.

Treatment Details

Interventions

• Paclitaxel (Other)
• Pembrolizumab (Monoclonal Antibodies)
• Pertuzumab (Monoclonal Antibodies)
• Trastuzumab (Monoclonal Antibodies)

Trial Overview The study compares three pre-surgery drug combinations for breast cancer: THP (trastuzumab + pertuzumab + paclitaxel), THP-K (THP plus pembrolizumab), and TH-K (trastuzumab + pembrolizumab + paclitaxel). It aims to see which combination is most effective and safe before standard surgery and follow-up care.

Participant Groups

Group I: Arm C: TH-K Experimental Treatment 3 Interventions

Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.

Group II: Arm B: THP-K Experimental Treatment 4 Interventions

Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.

Group III: Arm A: THP Active Control 3 Interventions

Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.

Paclitaxel is already approved in Canada for the following indications:

Approved in Canada as Paclitaxel for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University