A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2027
  • participants needed
    650
  • sponsor
    Seagen Inc.
Updated on 11 May 2022

Summary

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

Description

Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days

Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days

Trastuzumab and pertuzumab will be administered as follows:

• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days.

AND

  • Pertuzumab will be given IV at 420 mg every 21 days. OR
  • Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.

Details
Condition HER2 Positive Breast Cancer
Treatment Placebo, Trastuzumab, Pertuzumab, Tucatinib, Combination product: Trastuzumab + Pertuzumab
Clinical Study IdentifierNCT05132582
SponsorSeagen Inc.
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines
Have unresectable locally advanced or metastatic disease
If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab or pertuzumab received for advanced HER2+ disease
Have received 4-8 cycles (21 day cycles) of previous treatment with trastuzumab
Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
with no evidence of disease progression
CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants may have any of the following
No evidence of brain metastases
Untreated brain metastases which are asymptomatic and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
Previously treated brain metastases which are asymptomatic
Brain metastases previously treated with local therapy must not have progressed since treatment

Exclusion Criteria

Unable to undergo contrast MRI of the brain
CNS Exclusion - Based on screening brain MRI and clinical assessment
Prior treatment with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
Symptomatic brain metastasis
Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
Any untreated brain lesion in an anatomic site which may pose risk to participant
Known or suspected leptomeningeal disease (LMD)
Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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