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HER2-targeted Therapy + Immunotherapy for Breast Cancer

Q: What are some common reasons why a doctor might prescribe Paclitaxel to their patient?

<p>Paclitaxel is an effective treatment for <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, as well as other diseases like neoplasm metastasis, cyclophosphamide, and metastatic ureter urothelial carcinoma.</p>

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months from randomization

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathological complete response (pCR)

Secondary outcome measures

AEs and SAEs

Breast conserving surgery rate

Event free survival

+6 more

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

~5380

Trastuzumab

2014

Completed Phase 4

~5190

Pertuzumab

2014

Completed Phase 3

~7500

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Breast Cancer Research FoundationOTHER

69 Previous Clinical Trials

137,629 Total Patients Enrolled

41 Trials studying Breast Cancer

130,339 Patients Enrolled for Breast Cancer

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,683 Total Patients Enrolled

16 Trials studying Breast Cancer

1,950 Patients Enrolled for Breast Cancer

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,625 Total Patients Enrolled

21 Trials studying Breast Cancer

6,088 Patients Enrolled for Breast Cancer

Media Library

Paclitaxel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03747120 — Phase 2

Breast Cancer Research Study Groups: Arm A: THP, Arm B: THP-K, Arm C: TH-K

Breast Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT03747120 — Phase 2

Paclitaxel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03747120 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When was the last time that the FDA cleared paclitaxel for use?

"While there is some evidence for its safety, Paclitaxel only received a score of 2 because Phase 2 trials lack data demonstrating the medication's efficacy."

Answered by AI

Are patients able to sign up for this experiment at this time?

"This study, which is posted on clinicaltrials.gov and was last updated on 8/25/2022, is actively recruiting patients."

Answered by AI

What is the total number of patients involved in this clinical trial?

"174 patients that fit the bill are required for this clinical study. Merck Sharp & Dohme LLC will administer the trial from several locations, with two of those being Massachusetts General Hospital in Boston, MA and UT Southwestern Medical Center in Dallas, TX."

Answered by AI

What other treatments has Paclitaxel been tested in combination with?

"City of Hope Comprehensive Cancer Center first began studying paclitaxel in 1997 and, as of now, 1640 clinical trials have been completed. At the moment, there are 1915 active studies being conducted; a large number of these taking place in Boston, Massachusetts."

Answered by AI

How many different hospitals are participating in this research project?

"This trial is taking place in several locations, including but not limited to Massachusetts General Hospital in Boston, MA; UT Southwestern Medical Center in Dallas, TX; and Cedars Sinai Medical Center in Los Angeles, CA."

Answered by AI

What are some common reasons why a doctor might prescribe Paclitaxel to their patient?

"Paclitaxel is an effective treatment for melanoma, as well as other diseases like neoplasm metastasis, cyclophosphamide, and metastatic ureter urothelial carcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab

Heather McArthur 2019. "Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03747120.

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