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ACTIVE NOT RECRUITING Phase 3

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

NCT05132582 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Trastuzumab
  • DRUG Placebo
  • DRUG Tucatinib
  • DRUG Pertuzumab
  • DRUG Combination product: Trastuzumab + Pertuzumab

Study Locations (20)

California

  • UCLA Hematology/Oncology - Beverly Hills — Beverly Hills
  • UCLA Hematology/Oncology - Burbank — Burbank
  • UCSD Medical Center - Encinitas — Encinitas
  • Sulpizio Cardiovascular Center at UC San Diego Health — La Jolla
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla
  • UCSD Koman Family Outpatient Pavilion — La Jolla
  • UCSD Perlman Medical Offices — La Jolla
  • UC San Diego Moores Cancer Center — La Jolla
  • UCLA Hematology/Oncology - Laguna Hills — Laguna Hills
  • Administrative Address: UCLA Hematology/Oncology — Los Angeles
  • UCLA Hematology/Oncology — Los Angeles
  • UCSD Medical Center - Bankers Hill — San Diego
  • UC San Diego Medical Center - Hillcrest — San Diego
  • UCLA Hematology/Oncology - San Luis Obispo — San Luis Obispo
  • UCLA Hematology/Oncology- Santa Barbara — Santa Barbara
  • UCLA Hematology/Oncology - Santa Monica — Santa Monica
  • UCLA Hematology/Oncology Parkside — Santa Monica

Arizona

  • Mayo Clinic Hospital — Phoenix
  • Mayo Clinic — Scottsdale

Arkansas

  • Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI — Little Rock

Trial Details

FieldValue
Enrollment Target 654 participants
Start Date 2022-03-07
Est. Completion 2027-09-28
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05132582

The ClinicalTrials.gov registry entry for NCT05132582 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with HER2 Positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05132582 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05132582 about?

NCT05132582 is a clinical study titled "A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer". 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 participa...

What is the current status of trial NCT05132582?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 654 participants. The study started on 2022-03-07. Estimated completion is 2027-09-28.

What conditions does trial NCT05132582 study?

This clinical trial studies the following conditions: HER2 Positive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05132582?

The interventions under investigation include: Trastuzumab (DRUG), Placebo (DRUG), Tucatinib (DRUG), Pertuzumab (DRUG), Combination product: Trastuzumab + Pertuzumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05132582?

This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05132582 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial