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ACTIVE NOT RECRUITING Phase 3

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

NCT03975647 · View on ClinicalTrials.gov ↗

Study Summary

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

Interventions

  • DRUG placebo
  • DRUG T-DM1
  • DRUG tucatinib

Study Locations (20)

California

  • UCLA Hematology/Oncology - Alhambra — Alhambra
  • Kaiser Permanente Medical Center Lab Drawing Station — Antioch
  • Kaiser Permanente Medical Center Lab Drawing Station — Antioch
  • UCLA Hematology/Oncology- Beverly Hills — Beverly Hills
  • UC Irvine Health Cancer Center - Newport — Costa Mesa
  • City of Hope Investigational Drug Services (IDS) — Duarte
  • City of Hope(City of Hope National Medical Center,City of Hope Medical Center) — Duarte
  • Kaiser Permanente Medical Center (Radiology) — Dublin
  • UCLA Hematology/Oncology - Encino — Encino
  • Kaiser Permanente Medical Center Lab Drawing Station — Fairfield
  • Kaiser Permanente Medical Center Lab Drawing Station — Gilroy

Arizona

  • Banner Gateway Medical Center — Gilbert
  • Banner MD Anderson Cancer Center — Gilbert
  • Western Regional Medical Center, LLC — Goodyear
  • Arizona Oncology Associates, PC - HOPE. — Tucson
  • Arizona Oncology Associates, PC - HOPE — Tucson
  • Arizona Oncology Associates, PC - HOPE — Tucson

Alabama

  • University of South Alabama Health Children's and Women's Hospital — Mobile
  • University of South Alabama Mitchell Cancer Institute — Mobile
  • University of South Alabama Health University Hospital — Mobile

Trial Details

FieldValue
Enrollment Target 466 participants
Start Date 2019-10-02
Est. Completion 2029-03-10
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03975647

The ClinicalTrials.gov registry entry for NCT03975647 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 466 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 3 interventions — of which placebo 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: NCT03975647 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. 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 NCT03975647 about?

NCT03975647 is a clinical study titled "A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer". This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the bod...

What is the current status of trial NCT03975647?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2019-10-02. Estimated completion is 2029-03-10.

What conditions does trial NCT03975647 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 NCT03975647?

The interventions under investigation include: placebo (DRUG), T-DM1 (DRUG), tucatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03975647?

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 NCT03975647 being conducted?

This trial has 20 study locations across Alabama, Arizona, 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