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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03975647

Studienbeginn:
Oktober 2019

Letztes Update:
24.02.2021

Wirkstoff:
Tucatinib, Placebo, T-DM1

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Seagen Inc.

Collaborator:
-

Studienleiter

Evelyn Rustia, MD
Study Director
Seagen Inc.

Kontakt

Studienlocations (3 von 115)

University of South Alabama - Mitchell Cancer Institute
36604 Mobile
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Pam Francisco
Phone: 251-445-9870
E-Mail: pfrancisco@health.southalabama.edu
» Ansprechpartner anzeigen
Cancer Treatment Centers of America / Western Regional Medical Center
85338 Goodyear
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jessica Coats
Phone: 623-207-3126
E-Mail: jessica.coats@ctca-hope.com
» Ansprechpartner anzeigen
California Cancer Associates for Research and Excellence Inc (cCARE)
92024 Encinitas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Juan Morales
Phone: 760-747-8935
E-Mail: jmorales2@ccare.com
» Ansprechpartner anzeigen
Chao Family Comprehensive Cancer Center University of California Irvine
92868 Orange
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Pamela Diaz
Phone: 714-456-8614
E-Mail: Pamelad1@uci.edu
» Ansprechpartner anzeigen
University of California at San Francisco
94134 San Francisco
United StatesRekrutierend» Google-Maps
UCLA Medical Center / David Geffen School of Medicine
90504 Santa Monica
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Monica Rocha
Phone: 310-582-6324
E-Mail: mprocha@mednet.ucla.edu
» Ansprechpartner anzeigen
University of Colorado Hospital / University of Colorado
80045-0510 Aurora
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Leah Adams
Phone: 720-848-7341
E-Mail: leah.adams@cuanschutz.edu
» Ansprechpartner anzeigen
University of Colorado Health Memorial Hospital
80909 Colorado Springs
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Autumn Clemons
Phone: 719-365-5746
E-Mail: autumn.clemons@uchealth.org
» Ansprechpartner anzeigen
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
80026 Lafayette
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Nicole Steiner
Phone: 303-318-3434
E-Mail: nicole.steiner@sclhealth.org
» Ansprechpartner anzeigen
Helen F. Graham Cancer Center / Christiana Care Health Systems
19713 Newark
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Elizabeth MacWade
Phone: 302-623-4500
E-Mail: elizabeth.macwade@usoncology.com
» Ansprechpartner anzeigen
H. Lee Moffitt Cancer Center and Research Institute
33612 Tampa
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
33401 West Palm Beach
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jenifer Bar-Nur
Phone: 561-472-1696
E-Mail: jbar-nur@flcancer.com
» Ansprechpartner anzeigen
Winship Cancer Institute / Emory University School of Medicine
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Vanessa Falero
Phone: 404-778-1900
E-Mail: vanessa.falero@emoryhealthcare.org
» Ansprechpartner anzeigen
Kapi'olani Medical Center for Women and Children
96826 Honolulu
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Emelie Chang
Phone: 808-983-8749
E-Mail: emelie.chang@hawaiipacifichealth.org
» Ansprechpartner anzeigen
Illinois Cancer Specialists - Arlington Heights
60005 Arlington Heights
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Heather Lee
Phone: 847-259-4482
E-Mail: heather.lee@usoncology.com
» Ansprechpartner anzeigen
American Oncology Partners of Maryland, P.A.
20817 Bethesda
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Natalie Bongiorno
Phone: 301-571-2016
E-Mail: Natalie.Bongiorno@aoncology.com
» Ansprechpartner anzeigen
North Mississippi Medical Center Hematology Oncology - Tupelo
38801 Tupelo
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jeff Michelletti
Phone: 662-377-4550
E-Mail: jnmichelletti@nmhs.net
» Ansprechpartner anzeigen
Rutgers Cancer Institute of New Jersey / Robert Wood Johnson Medical School
08903-2681 New Brunswick
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Paige Harris
Phone: 732-235-9659
E-Mail: ph375@cinj.rutgers.edu
» Ansprechpartner anzeigen
New York Oncology Hematology, P.C.
12206 Albany
United StatesRekrutierend» Google-Maps
Stony Brook University Cancer Center
11794-7263 Stony Brook
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Pushpa Talanki
Phone: 631-638-0815
E-Mail: pushpa.talanki@stonybrookmedicine.edu
» Ansprechpartner anzeigen
Cancer Treatment Centers of America / Eastern Regional Medical Center
19124 Philadelphia
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Marianne Bonner
Phone: 215-537-4881
E-Mail: Marianne.Bonner@ctca-hope.com
» Ansprechpartner anzeigen
Texas Oncology - Bedford
76022 Bedford
United StatesRekrutierend» Google-Maps
Texas Oncology - Baylor Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jonathan Huntzinger
Phone: 214-370-1000
E-Mail: jonathan.huntzinger@usoncology.com
» Ansprechpartner anzeigen
University of Texas Southwestern Medical Center
75390 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jessica Medina
Phone: 214-648-7041
E-Mail: Jessica.Medina2@utsouthwestern.edu
» Ansprechpartner anzeigen
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
24060 Salem
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Natasha Holt
Phone: 540-774-8660
E-Mail: natasha.holt@usoncology.com
» Ansprechpartner anzeigen
Breast Cancer Research Centre
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Grand Hôpital de Charleroi - Saint-Joseph
6000 Charleroi
BelgiumRekrutierend» Google-Maps
CHU UCL Namur-Site de Saint Elisabeth
5000 Namur
BelgiumRekrutierend» Google-Maps
University of Alberta / Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Seattle Genetics Trial Information Support
Phone: 866-333-7436
E-Mail: clinicaltrials@seagen.com
» Ansprechpartner anzeigen
Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval
G1S 4L8 Quebec
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Seattle Genetics Trial Information Support
Phone: 866-333-7426
E-Mail: clinicaltrials@seagen.com
» Ansprechpartner anzeigen
Institut Claudius Regaud IUCT-O
31059 Toulouse Cedex
FranceRekrutierend» Google-Maps
Meir Medical Center
44281 Kfar Saba
IsraelAktiv, nicht rekrutierend» Google-Maps
Kaplan Medical Center
76100 Rehovot
IsraelNoch nicht rekrutierend» Google-Maps
National Hospital Organization Osaka
540-0006 Osaka
JapanRekrutierend» Google-Maps
Ansprechpartner:
Seattle Genetics Trial Information Support
Phone: 866-333-7436
E-Mail: clinicaltrials@seagen.com
» Ansprechpartner anzeigen
National Cancer Center Hospital
104-0045 Tokyo
JapanRekrutierend» Google-Maps
Seoul National University Bundang Hospital
463-707 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Seattle Genetics Trial Information Support
Phone: 866-333-7436
E-Mail: clinicaltrials@seagen.com
» Ansprechpartner anzeigen
Samsung Medical Center
135-710 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Seattle Genetics Trial Information Support
Phone: 866-333-7436
E-Mail: clinicaltrials@seagen.com
» Ansprechpartner anzeigen
Asan Medical Center - Oncology
Seoul
Korea, Republic ofRekrutierend» Google-Maps
University Hospital Basel - Brustzentrum
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Kantonsspital Winterthur (KSW)
8401 Winterthur
SwitzerlandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This study is designed to evaluate the efficacy and safety of tucatinib in combination with

T-DM1 in subjects with unresectable locally-advanced or metastatic HER2+ breast cancer who

have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab

treatment is permitted, but not required. Subjects will be randomized in a 1:1 manner to

receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.

While on study treatment, subjects will be assessed for progression every 6 weeks for the

first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions.

Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of

consent, or study closure. After completion of study treatment and after occurrence of

disease progression, subjects in both arms of the study will continue to be followed for

survival until study closure or withdrawal of consent.

Ein-/Ausschlusskriterien

- Inclusion Criteria:

- Histologically confirmed HER2+ metastatic breast carcinoma as determined by a

sponsor-designated central laboratory

- History of prior treatment with a taxane and trastuzumab in any setting,

separately or in combination

- Have progression of unresectable LA/M breast cancer after last systemic therapy,

or be intolerant of last systemic therapy

- Measurable or non-measurable disease assessable by RECIST v1.1

- Hormone receptor (estrogen receptor/progesterone receptor) status must be known

prior to randomization

- ECOG performance status score of 0 or 1

- Life expectancy ≥6 months

- CNS Inclusion - Based on screening contrast brain magnetic resonance imaging

(MRI), subjects must have at least one of the following:

(a) No evidence of brain metastases

(b) Untreated brain metastases not needing immediate local therapy

(c) Previously treated brain metastases

1. 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

2. Subjects treated with CNS local therapy for newly identified lesions may be

eligible to enroll if all of the following criteria are met:

(i) Time since SRS is at least 7 days prior to first dose of study

treatment, time since WBRT is at least 21 days prior to first dose, or time

since surgical resection is at least 28 days.

(ii) Other sites of evaluable disease are present

3. Relevant records of any CNS treatment must be available to allow for

classification of target and non-target lesions

- Exclusion Criteria:

- Prior treatment with tucatinib, neratinib, afatinib, trastuzumab deruxtecan

(DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent.

Prior treatment with lapatinib within 12 months of starting study treatment

(except in cases where lapatinib was given for <21 days and was discontinued for

reasons other than disease progression or severe toxicity).

- Prior treatment with T-DM1

- Treatment with any systemic anti-cancer therapy (including hormonal therapy),

non-CNS radiation, experimental agent or participation in another interventional

clinical trial ≤3 weeks prior to first dose of study treatment

- Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade

1, with the following exceptions:

1. Alopecia;

2. Neuropathy, which must have resolved to ≤ Grade 2;

3. Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity

at the time of occurrence, and must have resolved completely

- Clinically significant cardiopulmonary disease

- Myocardial infarction or unstable angina within 6 months prior to first dose of

study treatment

- Carrier of Hepatitis A or Hepatitis C or has other known chronic liver disease

- Positive for human immunodeficiency virus (HIV)

- Subjects who are pregnant, breastfeeding, or planning to become pregnant from

time of informed consent until 7 months following the last dose of study drug

- Unable to swallow pills or has significant gastrointestinal disease which would

preclude the adequate oral absorption of medications

- Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong

CYP3A4 or CYP2C8 inducer within 5 days prior to the first dose of study treatment

- CNS Exclusion - Based on screening contrast brain magnetic resonance imaging

(MRI), subjects must not have any of the following:

1. Any untreated brain lesions >2 cm in size

2. Ongoing use of corticosteroids for control of symptoms of brain metastases

at a total daily dose of >2 mg of dexamethasone (or equivalent).

3. Any brain lesion thought to require immediate local therapy

4. Known or concurrent leptomeningeal disease as documented by the investigator

5. Poorly controlled generalized or complex partial seizures

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment (Time Frame - Up to approximately 5 years):
PFS per investigator is defined as the time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.



Secondary outcome:

1. Overall Survival (Time Frame - Up to approximately 5 years):
OS is defined as the time from randomization to death due to any cause.

2. PFS per RECIST v1.1 by blinded independent committee review (BICR) (Time Frame - Up to approximately 5 years):
PFS per BICR is defined as the time from the date of randomization to the centrally-reviewed documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

3. PFS per RECIST v1.1 by investigator assessment in participants with brain metastases at baseline (Time Frame - Up to approximately 5 years)

4. PFS per RECIST v1.1 by BICR in patients with brain metastases at baseline (Time Frame - Up to approximately 5 years)

5. Objective response rate (ORR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST v1.1.

6. ORR per RECIST v1.1 by BICR (Time Frame - Up to approximately 3 years)

7. Duration of response (DOR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 5 years):
DOR is defined as the time from first documentation of objective response to the first documentation of disease progression or death from any cause, whichever occurs earlier.

8. DOR per RECIST v1.1 by BICR (Time Frame - Up to approximately 5 years)

9. Clinical benefit rate (CBR) per RECIST v1.1 by investigator assessment (Time Frame - Up to approximately 3 years):
CBR is defined as the proportion of subjects with stable disease (SD) or non-CR or non-PD for ≥6 months or best response of CR or PR according to RECIST v1.1.

10. CBR per RECIST v1.1 by BICR (Time Frame - Up to approximately 3 years)

11. Number of participants with adverse events (AEs) (Time Frame - Through 1 month following last dose; up to approximately 9 months overall per participant):
An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Studien-Arme

  • Experimental: Tucatinib + T-DM1
  • Active Comparator: Placebo + T-DM1

Geprüfte Regime

  • tucatinib (ONT-380):
    300mg given twice per day orally
  • placebo:
    Given twice per day orally
  • T-DM1 (Kadcyla):
    3.6 mg/kg given intravenously every 21 days

Quelle: ClinicalTrials.gov


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