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HER2-targeted Therapy + Immunotherapy for Breast Cancer

Phase 2

Waitlist Available

Led By Heather McArthur, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously untreated non-metastatic (M0), cT2-4N0 or cT1-4N1-3

Provides adequate archival tumor tissue sample or newly obtained core or excisional biopsy

Must not have

History of pneumonitis that required steroids or has current pneumonitis

Active autoimmune disease that has required systemic treatment in the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months from randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding the drug pembrolizumab to a standard treatment regimen for HER2-positive breast cancer improves outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of these drugs include allergic reactions to infusions; nerve damage causing pain or numbness; diarrhea; low blood cell counts leading to increased infection risk; heart problems due to trastuzumab; liver issues from pertuzumab; fatigue from paclitaxel; immune-related effects such as inflammation in organs from pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can provide a sample of my tumor for testing.

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I am a man and agree to use birth control and not donate sperm during treatment.

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I have HER2-positive breast cancer confirmed by a biopsy.

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I am not pregnant or breastfeeding and will follow birth control advice.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I am currently being treated for an infection.

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I have been treated with specific immune therapy before.

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I have another cancer that has been treated or progressed in the last 3 years.

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I have not had radiotherapy in the last 2 weeks.

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I have a serious heart condition.

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I have a history of HIV, Hepatitis B or C, or active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months from randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological complete response (pCR)

Secondary study objectives

AEs and SAEs

Breast conserving surgery rate

Event free survival

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: TH-KExperimental Treatment3 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-KExperimental Treatment4 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: THPActive Control3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Trastuzumab

2014

Completed Phase 4

~5190