Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

HER2CLIMB-05 : A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase III study is trying to understand whether targeted therapy (tucatinib) works better than placebo when given with other drugs (trastuzumab and pertuzumab) to treat people with HER2-positive breast cancer..
 

This trial is treating patients with HER2-Positive Breast Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

Commercial Sponsor

Seagen Inc.

Summary

Eligible participants will be randomly assigned to either the Experimental Arm or the Control Arm. In the Experimental Arm, participants will receive Tucatinib + trastuzumab + pertuzumab. Tucatinib (300mg) will be given by mouth (orally) twice daily. Tastuzumab will be given intravenously (via IV) at a dose of 6mg/kg or injected under the skin (subcutaneously) at a dose of 600mg, every 21 days. Pertuzumab (420mg) will be given via IV every 21 days. Alternatively, instead of receiving trastuzumab and pertuzumab individually, participants may receive a fixed dose combination of 600mg pertuzumab, 600mg trastuzumab, and 20,000 units hyaluronidase subcutaneously every 21 days. In the Control Arm, participants will receive Placebo + trastuzumab + pertuzumab. Placebo will be given orally, twice daily. Trastuzumab and Pertuzumab will be given as described in the Experimental Arm.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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