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Monoclonal Antibodies

Tucatinib + Trastuzumab + Pertuzumab for Breast Cancer (HER2CLIMB-05 Trial)

Q: How is Trastuzumab most commonly employed?

<p>Trastuzumab, while commonly used to manage <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, can also be used to ameliorate other issues like drug extravasation and primary immunodeficiencies.</p>

Phase 3

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

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

Must have

Have unresectable locally advanced or metastatic disease

Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

HER2CLIMB-05 Trial Summary

This trial is testing to see if adding tucatinib to trastuzumab and pertuzumab will help people with HER2-positive breast cancer live longer without their disease getting worse.

Who is the study for?

This trial is for individuals with HER2-positive breast cancer that's locally advanced, unresectable, or metastatic. Participants should have received specific induction therapy without disease progression and can't be undergoing certain treatments or have poorly controlled seizures. They must not need immediate treatment for brain metastases and should not have symptomatic brain lesions posing risk.Check my eligibility

What is being tested?

The study tests if tucatinib plus trastuzumab and pertuzumab is more effective than a placebo combined with the same drugs in treating HER2-positive breast cancer. It's randomized and blinded, meaning participants won't know if they're receiving tucatinib or a placebo.See study design

What are the potential side effects?

Potential side effects include reactions to the drug combination such as fatigue, nausea, allergic responses, potential heart issues due to trastuzumab and pertuzumab, as well as any unforeseen effects of tucatinib since it's being tested.

HER2CLIMB-05 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer cannot be removed by surgery and has spread.

Select...

My breast cancer is HER2 positive as per the latest guidelines.

Select...

I have had brain metastases treatment and currently have no symptoms.

Select...

I do not have cancer that has spread to my brain.

Select...

I have brain metastases from cancer that don't need immediate treatment and haven't worsened since my last therapy.

Select...

I've had 4-8 rounds of specific breast cancer treatment without the cancer getting worse.

Select...

My brain cancer has not worsened after treatment.

Select...

I am fully active or can carry out light work.

HER2CLIMB-05 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary outcome measures

Central nervous system (CNS) PFS

Incidence of adverse events (AEs)

Incidence of laboratory abnormalities

+8 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Neurotoxicity

13%

Alanine aminotransferase increased

13%

Cough

13%

Vomting

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

HER2CLIMB-05 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tucatinib + trastuzumab + pertuzumabExperimental Treatment4 Interventions

Tucatinib + trastuzumab + pertuzumab

Group II: Placebo + trastuzumab + pertuzumabActive Control4 Interventions

Placebo + trastuzumab + pertuzumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tucatinib

2017

Completed Phase 2

~520

Pertuzumab

2014

Completed Phase 3

~7500

Trastuzumab

2014

Completed Phase 4

~5190

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

73,578 Total Patients Enrolled

6 Trials studying Breast Cancer

3,308 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,496 Total Patients Enrolled

59 Trials studying Breast Cancer

7,498 Patients Enrolled for Breast Cancer

Medical MonitorStudy DirectorSeagen Inc.

1,660 Previous Clinical Trials

983,179 Total Patients Enrolled

9 Trials studying Breast Cancer

699 Patients Enrolled for Breast Cancer

Media Library

Pertuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05132582 — Phase 3

Breast Cancer Research Study Groups: Placebo + trastuzumab + pertuzumab, Tucatinib + trastuzumab + pertuzumab

Breast Cancer Clinical Trial 2023: Pertuzumab Highlights & Side Effects. Trial Name: NCT05132582 — Phase 3

Pertuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132582 — Phase 3

Frequently Asked Questions

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

What is the scientific history of Trastuzumab?

"As of right now, there are 245 clinical trials involving Trastuzumab with 66 of them being in Phase 3. Most of these trials are taking place in Seattle, Washington; however, there are a total of 18848 locations running clinical trials for Trastuzumab."

Answered by AI

Has the government organization known as the FDA given its thumbs up to Trastuzumab?

"Trastuzumab is a phase 3 medication, meaning that there is evidence of its efficacy and that it has undergone multiple rounds of testing for safety. Our team rates its safety as a 3."

Answered by AI

How many volunteers will be participating in this experiment?

"650 patients that meet the specified inclusion criteria are required for this study to run its course. The sponsor, Merck Sharp & Dohme LLC, has chosen various locations to execute the trial, such as Seattle Cancer Care Alliance / University of Washington in Seattle, Washington and Thomas Jefferson-Abington in Willow Grove, Pennsylvania."

Answered by AI

How is Trastuzumab most commonly employed?

"Trastuzumab, while commonly used to manage breast cancer, can also be used to ameliorate other issues like drug extravasation and primary immunodeficiencies."

Answered by AI

Are volunteers still being accepted for this drug trial?

"The clinical trial was first posted on 3/7/2022 and was most recently updated on 10/28/2022, meaning that the study is still actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

2022. "A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05132582.

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