Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Nicholas McAndrew (ucla)

Description

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.

Official 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)

Details

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.

Keywords

HER2 Positive Breast Cancer HER2+ breast cancer Breast Cancer Metastatic breast cancer Seattle Genetics Breast Neoplasms Trastuzumab Pertuzumab Tucatinib Combination product: Trastuzumab + Pertuzumab Tucatinib + trastuzumab + pertuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression
  • 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 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

You CAN'T join if...

  • 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)
  • Unable to undergo contrast MRI of the brain
  • CNS Exclusion - Based on screening brain MRI and clinical assessment
  • 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

Locations

  • UCLA Medical Center / David Geffen School of Medicine accepting new patients
    Santa Monica California 90404 United States
  • Mayo Clinic Arizona accepting new patients
    Phoenix Arizona 85054 United States

Lead Scientist at UC Cancer

  • Nicholas McAndrew (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 12 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT05132582
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 650 study participants
Last Updated