Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Trial acronym
HER2CLIMB-05
Clinical summary
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.
Conditions
This trial is treating people with HER2-Positive Breast Cancer
Eligibility
Inclusion
- 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).
-
Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
- Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
- Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-
CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following:
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Seagen Inc.
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)
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information