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

Primary Purpose

Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tucatinib
trastuzumab
fulvestrant
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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
    • 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

Exclusion Criteria

  • 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.

Sites / Locations

  • Arizona Oncology Associates, PC - HAL
  • HonorHealth
  • Mayo Clinic Arizona
  • Arizona Cancer Center / University of Arizona
  • UC San Diego / Moores Cancer Center
  • Pacific Shores Medical Group
  • Rocky Mountain Cancer Centers
  • Regional Cancer Care Associates
  • Lombardi Cancer Center / Georgetown University Medical Center
  • Mayo Clinic Florida
  • H. Lee Moffitt Cancer Center and Research Institute
  • University Cancer & Blood Center, LLC
  • Massachusetts General Hospital
  • Mayo Clinic Rochester
  • HealthPartners Institute
  • Washington University in St Louis
  • Nebraska Cancer Specialists
  • NYU Langone Hospital
  • NYU Langone Hospital
  • Mount Sinai Medical Center
  • Duke University Medical Center
  • Case Western Reserve University / University Hospitals Cleveland Medical Center
  • James Cancer Hospital / Ohio State University
  • University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
  • Prisma Health
  • Tennessee Oncology-Nashville/Sarah Cannon Research Institute
  • Texas Oncology - West Texas
  • Texas Oncology, P.A. - Dallas
  • MD Anderson Cancer Center / University of Texas
  • Texas Oncology - Waco
  • Huntsman Cancer Institute/University of Utah
  • Virginia Cancer Specialists, PC
  • Seattle Cancer Care Alliance / University of Washington
  • Northwest Cancer Specialists, P.C.
  • Carbone Cancer Center / University of Wisconsin
  • Cliniques Universitaires Saint Luc
  • Grand Hopital de Charleroi
  • Universitair Ziekenhuis Antwerpen
  • Academisch Ziekenhuis Groeninge
  • CHU de Liege
  • AZ Sint-Maarten
  • Charite Universitatsmedizin Berlin
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
  • Istituto Europeo di Oncologia
  • Azienda Socio Sanitaria Territoriale di Monza. Ospedale San Gerardo
  • National Cancer Center Hospital
  • National Cancer Center Hospital East
  • St. Marianna University School of Medicine
  • Aichi Cancer Center
  • Kindai University Hospital
  • The Cancer Institute Hospital of JFCR
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • Seoul National University Boramae Medical Center
  • Severance Hospital, Yonsei University Health System
  • Netherlands Cancer Institute
  • Med Polonia Sp. z o. o.
  • Hospital Universitario Vall d'Hebron
  • L'Institut Catala d'Oncologia
  • Hospital Universitario 12 de Octubre
  • Hospital Clinico Universitario de Santiago de Compostela
  • Hospital Clinico Universitario de Valencia
  • The Royal Marsden Hospital
  • Sarah Cannon Research Institute UK
  • The Royal Marsden Hospital (Surrey)
  • Guy's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tucatinib + Trastuzumab (+ Fulvestrant)

Arm Description

Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)

Outcomes

Primary Outcome Measures

Confirmed objective response rate (cORR) per investigator assessment
cORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Disease control rate (DCR) per investigator assessment
DCR is defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease according to RECIST v1.1
Duration of response (DOR) per investigator assessment
DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Progression-free survival (PFS) per investigator assessment
PFS is defined as the time from the date of treatment initiation to the date of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Overall survival (OS)
OS is defined as the time from treatment initiation to death due to any cause.
Incidence of adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
Incidence of dose alterations
Maximum concentration (Cmax)
To be summarized using descriptive statistics.
Trough concentration (Ctrough)
To be summarized using descriptive statistics.

Full Information

First Posted
October 1, 2020
Last Updated
April 21, 2023
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04579380
Brief Title
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms, Carcinoma, Non-Small-Cell Lung, HER2 Mutations Breast Neoplasms
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tucatinib + Trastuzumab (+ Fulvestrant)
Arm Type
Experimental
Arm Description
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)
Intervention Type
Drug
Intervention Name(s)
tucatinib
Other Intervention Name(s)
TUKYSA, ARRY-380, ONT-380
Intervention Description
300 mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Confirmed objective response rate (cORR) per investigator assessment
Description
cORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
From start of treatment up to approximately 2 years
Secondary Outcome Measure Information:
Title
Disease control rate (DCR) per investigator assessment
Description
DCR is defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease according to RECIST v1.1
Time Frame
From start of treatment up to approximately 2 years
Title
Duration of response (DOR) per investigator assessment
Description
DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Time Frame
From start of treatment up to approximately 2 years
Title
Progression-free survival (PFS) per investigator assessment
Description
PFS is defined as the time from the date of treatment initiation to the date of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Time Frame
From start of treatment up to approximately 2 years
Title
Overall survival (OS)
Description
OS is defined as the time from treatment initiation to death due to any cause.
Time Frame
From start of treatment up to approximately 4 years
Title
Incidence of adverse events (AEs)
Description
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time Frame
From start of treatment up to approximately 2 years
Title
Incidence of laboratory abnormalities
Description
To be summarized using descriptive statistics.
Time Frame
From start of treatment up to approximately 2 years
Title
Incidence of dose alterations
Time Frame
From start of treatment up to approximately 2 years
Title
Maximum concentration (Cmax)
Description
To be summarized using descriptive statistics.
Time Frame
Approximately 4 months, during first 6 cycles of treatment
Title
Trough concentration (Ctrough)
Description
To be summarized using descriptive statistics.
Time Frame
Approximately 4 months, during first 6 cycles of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 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 Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Ramos, DO
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - HAL
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
HonorHealth
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Arizona Cancer Center / University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UC San Diego / Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Regional Cancer Care Associates
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Lombardi Cancer Center / Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University Cancer & Blood Center, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
HealthPartners Institute
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Washington University in St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
NYU Langone Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
NYU Langone Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case Western Reserve University / University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
James Cancer Hospital / Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - West Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Oncology, P.A. - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Northwest Cancer Specialists, P.C.
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Carbone Cancer Center / University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
State/Province
Other
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital de Charleroi
City
Charleroi
State/Province
Other
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
State/Province
Other
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Academisch Ziekenhuis Groeninge
City
Kortrijk
State/Province
Other
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU de Liege
City
Liege
State/Province
Other
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Sint-Maarten
City
Mechelen
State/Province
Other
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
State/Province
Other
ZIP/Postal Code
12203
Country
Germany
Facility Name
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
City
Meldola
State/Province
Other
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
Other
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale di Monza. Ospedale San Gerardo
City
Monza
State/Province
Other
ZIP/Postal Code
20900
Country
Italy
Facility Name
National Cancer Center Hospital
City
Chuo-Ku
State/Province
Other
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Other
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
St. Marianna University School of Medicine
City
Kawasaki-shi
State/Province
Other
ZIP/Postal Code
2168511
Country
Japan
Facility Name
Aichi Cancer Center
City
Nagoya-shi
State/Province
Other
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Other
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
State/Province
Other
ZIP/Postal Code
81004
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Other
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Other
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Other
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
State/Province
Other
ZIP/Postal Code
07671
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Other
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Netherlands Cancer Institute
City
Amsterdam
State/Province
Other
ZIP/Postal Code
1066 WX
Country
Netherlands
Facility Name
Med Polonia Sp. z o. o.
City
Poznan
State/Province
Other
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
State/Province
Other
ZIP/Postal Code
08035
Country
Spain
Facility Name
L'Institut Catala d'Oncologia
City
L'Hospitalet de Llobregat
State/Province
Other
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
Other
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
Other
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
State/Province
Other
ZIP/Postal Code
46010
Country
Spain
Facility Name
The Royal Marsden Hospital
City
London
State/Province
Other
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
State/Province
Other
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
The Royal Marsden Hospital (Surrey)
City
Sutton
State/Province
Other
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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