Breast Cancer Clinical Trial

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Summary

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer.

Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Have confirmed HER2+ breast cancer, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines, previously determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory.
History of prior treatment with a taxane and trastuzumab in the LA/M setting OR progressed within 6 months after neoadjuvant or adjuvant treatment, including a taxane and trastuzumab.
Have progression of unresectable LA/M breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
Have measurable disease assessable by RECIST v1.1
Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
Have a life expectancy of at least 6 months, in the opinion of the investigator

CNS Inclusion - Based on medical history and screening contrast brain magnetic resonance imaging (MRI), participants with a history of brain metastases must have one of the following:

Untreated brain metastases not needing immediate local therapy. For participants with untreated central nervous system (CNS) lesions >2.0 cm on screening contrast brain MRI, discussion with and approval from the medical monitor is required prior to enrollment

Previously treated brain metastases

Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator

Participants treated with CNS local therapy for newly identified or previously treated progressing lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:

Time since whole brain radiation therapy (WBRT) is ≥14 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥7 days prior to first dose of study treatment, or time since surgical resection is ≥28 days
Other sites of measurable disease by RECIST v1.1 are present
Relevant records of any CNS treatment must be available

Exclusion Criteria

Have previously been treated with:

Lapatinib or neratinib within 12 months of starting study treatment (except in cases where lapatinib or neratinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity)
Tucatinib or enrolled on a tucatinib clinical trial
Any investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) (eg, afatinib) at any time previously
Trastuzumab deruxtecan or another antibody-drug conjugate (ADC) consisting of an exatecan derivative

Have received treatment with:

Any systemic anti-cancer therapy (including hormonal therapy) or experimental agent ≤21 days of first dose of study treatment or are currently participating in another interventional clinical trial. An exception for the washout of hormonal therapies is gonadotropin releasing hormone (GnRH) agonists used for ovarian suppression in premenopausal women, which are permitted concomitant medications
Treatment with non-CNS radiation ≤7 days prior to first dose of study treatment
Major surgery <28 days of first dose study treatment
Have clinically significant cardiopulmonary disease (such as history of iterstitial lung disease (ILD)/pneumonitis that required systemic corticosteroids, or have current ILD/pneumonitis, or where suspected ILD /pneumonitis cannot be ruled out be imaging at screening)
Have known myocardial infarction or unstable angina within 6 months prior to first dose of study treatment
Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection. Participants who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks
Presence of known chronic liver disease
Active or uncontrolled clinically serious infection
Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT04539938

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 32 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Nazma Chowdhury
Contact
205-934-4778
[email protected]
Erica Stringer-Reasor
Principal Investigator
Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85704, United States More Info
Ana Vasquez
Contact
281-863-5639
[email protected]
Rachel Swart
Principal Investigator
City of Hope National Medical Center
Duarte California, 91010, United States More Info
Sayeh Lavasani
Contact
626-256-4673
[email protected]
Sayeh Lavasani
Principal Investigator
UCLA Department of Medicine - Hematology & Oncology
Los Angeles California, 90095, United States More Info
Monica Rocha
Contact
310-998-4747
[email protected]
Sara Hurvitz
Principal Investigator
University of California at San Francisco
San Francisco California, 94134, United States More Info
Nathalie Kacik
Contact
415-885-7213
[email protected]
Amy Jo Chien
Principal Investigator
University of Colorado Hospital / University of Colorado
Aurora Colorado, 80045, United States More Info
Leah Adams
Contact
720-848-7341
[email protected]
Virginia Borges
Principal Investigator
Lombardi Cancer Center / Georgetown University Medical Center
Washington District of Columbia, 20007, United States More Info
Claudine Isaacs
Principal Investigator
Florida Cancer Specialists - North Region
Saint Petersburg Florida, 33705, United States More Info
Katie Goodman
Contact
[email protected]
Gail Wright
Principal Investigator
Winship Cancer Institute / Emory University School of Medicine
Atlanta Georgia, 30322, United States More Info
Jane Meisel
Contact
404-778-1900
[email protected]
Jane Meisel
Principal Investigator
Georgia Cancer Specialists / Northside Hospital Cancer Institute
Sandy Springs Georgia, 30341, United States More Info
Anila Lokhandwala
Contact
[email protected]
Amelia Zelnak
Principal Investigator
James Graham Brown Cancer Center / University of Louisville
Louisville Kentucky, 40202, United States More Info
University of Lousiville James Graham Brown Cancer Center
Contact
502-562-4673
Elizabeth Riley
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Nancy Lin
Principal Investigator
Allina Health Cancer Institute
Minneapolis Minnesota, 55407, United States More Info
Jacquelyn Underhill
Contact
612-863-3929
[email protected]
Amy Krie
Principal Investigator
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States More Info
Ciara O'Sullivan
Principal Investigator
Saint Luke's Cancer Institute LLC
Kansas City Missouri, 64113, United States More Info
Melissa Lising
Contact
816-932-2677
[email protected]
Timothy Pluard
Principal Investigator
HCA Midwest Health Kansas City
Kansas City Missouri, 64132, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States More Info
Megan Meays
Contact
402-691-6972
[email protected]
Margaret Block
Principal Investigator
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Aretha DiSalvo
Contact
551-996-8258
[email protected]
Deena Graham
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Shanu Modi
Principal Investigator
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill North Carolina, 27599, United States More Info
Tamara Pfeffer
Contact
919-966-4432
[email protected]
Lisa Carey
Principal Investigator
Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem North Carolina, 27157, United States More Info
Angela Howell
Contact
336-713-3155
[email protected]
Heather Kirby
Contact
336-713-6927
[email protected]
Susan Melin
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Christina Lopez
Contact
503-215-5696
[email protected]
Alison Conlin
Principal Investigator
Northwest Cancer Specialists, P.C.
Tigard Oregon, 97223, United States More Info
Jay Andersen
Principal Investigator
Magee Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States More Info
Claire Berger
Contact
412-641-6373
[email protected]
Adam Brufsky
Principal Investigator
Chattanooga Oncology and Hematology Associates/Tennessee Oncology-Memorial Plaza
Chattanooga Tennessee, 37404, United States More Info
Ask Sarah
Contact
844-482-4812
Brooke Daniel
Principal Investigator
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Ask Sarah
Contact
844-482-4812
Erika Hamilton
Principal Investigator
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas Texas, 75390, United States More Info
Ana Vasquez
Contact
281-863-5639
[email protected]
Kristi McIntyre
Principal Investigator
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Rashmi Murthy
Contact
713-745-4367
[email protected]
Rashmi Murthy
Principal Investigator
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States More Info
Ana Vasquez
Contact
281-863-5639
[email protected]
Anne Favret
Principal Investigator
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Salem Virginia, 24153, United States More Info
Ana Vasquez
Contact
281-863-5639
[email protected]
Paul Richards
Principal Investigator
Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States More Info
Shaveta Vinayak
Contact
206-606-6329
[email protected]
Shaveta Vinayak
Principal Investigator
Carbone Cancer Center / University of Wisconsin
Madison Wisconsin, 53792, United States More Info
Mark Burkard
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT04539938

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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