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Uterine NeoplasmsPhase 2NCT04579380

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

A Phase 2 study testing tucatinib, trastuzumab and fulvestrant in people with Uterine Neoplasms and Uterine Cervical Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 108 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tucatinib, trastuzumab and fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
108 sitesin 8 countries
Study dates
11 Jan 2021to 31 Dec 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
  • Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
  • Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease
  • Disease progression during or after, or intolerance of, the most recent line of systemic therapy
  • Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following:
  • HER2 overexpression/amplification from fresh or archival tumor tissue or blood
Show all 9Show fewer
  • Known activating HER2 mutations detected in fresh or archival tumor tissue or blood
  • Have measurable disease per RECIST v1.1 criteria according to investigator assessment
  • Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Who cannot join

  • Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression.
  • Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab
  • Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer
  • History of exposure to a 360 mg/m² doxorubicin-equivalent or >720 mg/m^2 epirubicin-equivalent cumulative dose of anthracyclines
  • Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial.
  • There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Trial locations and contacts

108 sites in 8 countries.

108 sites in 8 countries

United States76 sites

  • Texas oncology-West Texas

    Abilene, Texas, 79606

  • Virginia Cancer Specialists, PC

    Alexandria, Virginia, 22304

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22205

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Prisma Health Cancer Institute

    Boiling Springs, South Carolina, 29316

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • OSU Wexner Medical Center, CarePoint East

    Columbus, Ohio, 43203

  • OSU Wexner Medical Center, Ohio State University Hospital East

    Columbus, Ohio, 43203

  • OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute

    Columbus, Ohio, 43210

  • OSU Wexner Medical Center, Investigational Drug Services(IP Ship to)

    Columbus, Ohio, 43210

  • Osu Wexner Medical Center, The Ohio State University Hospital

    Columbus, Ohio, 43210

  • OSU Wexner Medical Center, Stephanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212

  • OSU Wexner Medical Center, Martha Morehouse Medical Plaza

    Columbus, Ohio, 43221

  • OSU Wexner Medical Center, OutPatient Care Upper Arlington

    Columbus, Ohio, 43221

  • Minnesota Oncology Hematology, PA

    Coon Rapids, Minnesota, 55433

  • Duke University Medical Center/Duke Cancer Center

    Durham, North Carolina, 27710

  • Prisma Health Cancer Institute

    Easley, South Carolina, 29640

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • OSU Wexner Medical Center, CarePoint Gahanna

    Gahanna, Ohio, 43230

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute

    Greer, South Carolina, 29650

  • Tennessee Oncology, PLLC

    Hendersonville, Tennessee, 37075

  • OSU Wexner Medical Center, Gynecologic Oncology at Mill Run

    Hilliard, Ohio, 43026

  • City of Hope at Huntington Beach

    Huntington Beach, California, 92648

  • City of Hope at Irvine Sand Canyon

    Irvine, California, 92618

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas, 75063

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • US Oncology lnvestigational Products Center (IPC)

    Irving, Texas, 75063

  • Koman Family Outpatient Pavilion

    La Jolla, California, 92037

  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

    La Jolla, California, 92037

  • UC San Diego Moores Cancer Center- Investigational Drug Services

    La Jolla, California, 92037

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

  • OSU Wexner Medical Center, Outpatient Care Lewis Center

    Lewis Center, Ohio, 43035

  • City of Hope at Long Beach Worsham

    Long Beach, California, 90808

  • City of Hope at Long Beach Elm

    Long Beach, California, 90813

  • 1 S Park St Medical Center

    Madison, Wisconsin, 53715

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • NYU Langone Health - Long Island (Winthrop Hospital)

    Mineola, New York, 11501

  • Perlmutter Cancer Center at NYU Langone GYN Oncology Associates

    Mineola, New York, 11501

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • NYU Langone Medical Center

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • City of Hope at Newport Beach Lido

    Newport Beach, California, 92663

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • UH Minoff Health Center at Chagrin Highlands

    Orange, Ohio, 44122

  • HonorHealth

    Phoenix, Arizona, 85016

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • Drug Storage and Regulatory location: MMCORC

    Saint Louis Park, Minnesota, 55426

  • Metro Minnesota Community Oncology Research Consortium (MMCORC)

    Saint Louis Park, Minnesota, 55426

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Prisma Health Cancer Institute

    Seneca, South Carolina, 29672

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices)

    St Louis, Missouri, 63108

  • Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS)

    St Louis, Missouri, 63110

  • Washington University School of Medicine - Obstetrics & Gynecology

    St Louis, Missouri, 63110

  • Washington University School of Medicine [Patient Clinics]

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • HonorHealth

    Tempe, Arizona, 85284

  • Rocky Mountain Cancer Centers

    Thornton, Colorado, 80260

  • Northwest Cancer Specialists, P.C.

    Tigard, Oregon, 97223

  • City of Hope Torrance

    Torrance, California, 90505

  • The University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Texas Oncology - Central South

    Waco, Texas, 76712

  • UPMC Hillman Cancer Center - Washington

    Washington, Pennsylvania, 15301

  • OSU Wexner Medical Center, Outpatient Care New Albany

    Westerville, Ohio, 43081

Other trials in United States

United Kingdom9 sites

  • Sarah Cannon Research Institute UK

    London, Budapest, W1G 6AD

  • Diagnostic Centre

    London, Others, W1G 7AF

  • Guy's Hospital

    London, SE1 9RT

  • Jonathan Poon

    London, SE1 9RT

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Harley Street Clinic

    London, W1G 8BJ

  • Radiology

    London, W1G 8PP

  • Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Belgium6 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hopital de Charleroi

    Charleroi, Hainaut, B- 6060

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • AZ Groeninge

    Kortrijk, 8500

  • CHU de Liege

    Liège, 4000

  • AZ Sint-Maarten

    Mechelen, 2800

Other trials in Belgium

Japan6 sites

  • National Cancer Center Hospital

    Cho-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Spain5 sites

  • Cetir Centre Medic

    Barcelona, 08029

  • Institut Catala d'Oncologia Hospitalet

    L'Hospitalet de Llobregat, Other, 8908

  • Hospital Clínico Universitario de Valencia. Fundación Investigación Clínico de Valencia.

    Valencia, 46010

  • Ascires Eresa Campanar

    Valencia, 46015

  • Hospital Vithas Valencia 9 de Octubre

    Valencia, 46015

Other trials in Spain

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Severance Hospital Yonsei University Health System

    Seoul, Other, 03722

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Germany1 site

  • Charite Universitatsmedizin Berlin

    Berlin, 12203

Other trials in Germany

Italy1 site

  • Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia

    Milan, Milan, 20141

Other trials in Italy

About this study

Official title: A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable).

All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant.

The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

Read the detailed description

There are multiple cohorts in this trial:

  • 5 tumor specific cohorts with HER2 overexpression/amplification (cervical cancer, uterine cancer, biliary tract cancer, urothelial cancer, and non-squamous non-small cell lung cancer [NSCLC])
  • 2 tumor specific cohorts with HER2 mutations (non-squamous NSCLC and breast cancer)
  • 2 cohorts which will enroll all other HER2 amplified/overexpressed solid tumor types (except breast cancer, gastric or gastroesophageal junction adenocarcinoma [GEC], and colorectal cancer [CRC]) or HER2-mutated solid tumor types.
Being tested
tucatinib, trastuzumab, fulvestrant
Keywords
Cervical cancer, Uterine cancer, Biliary tract cancer, Urothelial cancer, Non-squamous non-small cell lung cancer, Non-squamous NSCLC, Breast cancer, Colorectal cancer, Ampullary cancer, Solid tumors, Solid tumors harboring somatic HER2 mutations, Seattle Genetics
Medical subject headings
Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tucatinibDrug

    Also called TUKYSA, ARRY-380, ONT-380

    300 mg orally twice daily

  • trastuzumabDrug

    Also called Herceptin

    Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1

  • fulvestrantDrug

    Also called Faslodex

    Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.

Study groups in NCT04579380
Study groupRoleWhat they receive
Tucatinib + Trastuzumab (+ Fulvestrant)ExperimentalTucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
Receives: Drug: tucatinib; Drug: trastuzumab; Drug: fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (cORR) as Assessed by Investigator

    Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: at least a greater than or equal to (>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least >=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).

    Measured: From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)

Secondary outcomes (10)

  1. Confirmed Disease Control Rate (DCR) as Assessed by Investigator

    DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.

    Measured: From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 months)

  2. Duration of Response (DOR) as Assessed by Investigator

    DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least >=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD \& were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.

    Measured: From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)

  3. Progression-Free Survival (PFS) as Assessed by Investigator

    PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.

    Measured: From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)

  4. Overall Survival (OS)

    OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.

    Measured: From date of start of study treatment until date of death or censoring date (approximately 52.7 months)

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)

  6. Number of Participants With Treatment Emergent Laboratory Test Abnormalities

    Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment up to 30 days after the last dose of study treatment. The following laboratory abnormalities were assessed: A-) Hematology: hemoglobin decreased, leukocytes decreased, lymphocytes decreased and increased, neutrophils decreased and platelets decreased; B-) Chemistry: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin decreased and increased, creatinine increased, glomerular filtration rate estimated decreased, glucose decreased, lactate dehydrogenase increased, magnesium increased and decreased, potassium increased and decreased, sodium increased and decreased and total bilirubin increased.

    Measured: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)

  7. Number of Participants With Any Dose Modifications Due to AEs

    Dose modification included dose hold, dose reduction, or discontinuation of drugs. Dose reductions or treatment interruption/discontinuation were made at the discretion of the investigator.

    Measured: From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)

  8. Number of Participants With TEAEs of Special Interest

    An adverse event of special interest (AESI) were any serious or nonserious AE that were of scientific or medical concern as defined by the sponsor and specific to the program, for which ongoing monitoring and rapid communication to the sponsor were appropriate. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib, trastuzumab or fulvestrant). AESIs for this study were related to hepatoxicity.

    Measured: From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)

  9. Maximum Concentration (Cmax) of Tucatinib

    Measured: Cycle 3 Day 1: anytime within 1-4 hours post-dose

  10. Trough Concentration (Ctrough) of Tucatinib

    Measured: Cycle 3 Day 1: Predose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start11 Jan 2021
  3. Primary completion1 Nov 2023
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579380
Sponsor's protocol ID
SGNTUC-019
Status last verified
Aug 2026
First submitted
1 Oct 2020
Last updated
21 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Okines AFC, Curigliano G, Mizuno N, Oh DY, Rorive A, Soliman H, Takahashi S, Bekaii-Saab T, Burkard ME, Chung KY, Debruyne PR, Fox JR, Gambardella V, Gil-Martin M, Hamilton EP, Monk BJ, Nakamura Y, Nguyen D, O'Malley DM, Olawaiye AB, Pothuri B, Reck M, Sudo K, Sunakawa Y, Van Marcke C, Yu EY, Ramos J, Tan S, Bieda M, Stinchcombe TE, Pohlmann PR. Tucatinib and trastuzumab in HER2-mutated metastatic breast cancer: a phase 2 basket trial. Nat Med. 2025 Mar;31(3):909-916. doi: 10.1038/s41591-024-03462-0. Epub 2025 Jan 17.

    PubMed 39825152

  • Nakamura Y, Mizuno N, Sunakawa Y, Canon JL, Galsky MD, Hamilton E, Hayashi H, Jerusalem G, Kim ST, Lee KW, Kankeu Fonkoua LA, Monk BJ, Nguyen D, Oh DY, Okines A, O'Malley DM, Pohlmann P, Reck M, Shin SJ, Sudo K, Takahashi S, Van Marcke C, Yu EY, Groisberg R, Ramos J, Tan S, Stinchcombe TE, Bekaii-Saab T. Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study. J Clin Oncol. 2023 Dec 20;41(36):5569-5578. doi: 10.1200/JCO.23.00606. Epub 2023 Sep 26.

    PubMed 37751561

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tucatinib, trastuzumab and fulvestrant in people with Uterine Neoplasms and Uterine Cervical Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 108 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, United Kingdom, Belgium, Japan, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (cORR) as Assessed by Investigator (time frame: From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04579380, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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