A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:December 2015
End Date:July 2021
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

This study is being done to see if tucatinib works better than placebo 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. All patients in the study will get capecitabine and
trastuzumab, two drugs that are often used to treat this cancer.

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.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills
two times every day. They will swallow capecitabine pills two times a day during the first
two weeks of each cycle. Patients will get trastuzumab injections from the study site staff
on the first day of every cycle.

This is a randomized, international, multi-center, double-blinded study in patients with
progressive unresectable locally advanced or metastatic HER2+ breast cancer who have had
prior treatment with trastuzumab, pertuzumab and T-DM1. Patients will be randomized in a 2:1
ratio to receive tucatinib or placebo in combination with capecitabine and trastuzumab.

Stratification factors include presence or history of treated or untreated brain metastases
or brain lesions of equivocal significance (yes/no), Eastern Cooperative Oncology Group
(ECOG) Performance Status (0 vs. 1), and region of world (US vs. Canada vs. Rest of World).

No crossover from placebo to tucatinib will be allowed.

Safety assessments will be performed at a minimum of once every three weeks throughout study
treatment and 30 days after the last dose of study drugs. Laboratory assessments will be
performed locally at sites. Left ventricular ejection fraction will be assessed by MUGA or
ECHO at screening and once every 12 weeks thereafter.

Contrast brain MRI will be performed at baseline in all patients. Efficacy assessments (CT of
chest, abdomen and pelvis at a minimum) utilize RECIST 1.1 and include patients with
evaluable tumors defined as measurable target lesions and non-measurable non-target lesions.
RECIST assessment is performed at baseline, every 6 weeks for the first 24 weeks, and then
every 9 weeks thereafter. Repeat MRI of the brain will be required on this same schedule only
in those patients with brain metastases identified at baseline. All treatment decisions are
made based upon investigator assessment. All patients undergo a repeat MRI of the brain
within 30 days of the end of treatment unless previously performed at time of disease
progression. Patients in both arms of the study will be followed for OS after completion of
study treatment.

Inclusion Criteria

- Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ
hybridization (ISH) or fluorescence in situ hybridization (FISH) methodology

- Received previous treatment with trastuzumab, pertuzumab, and T-DM1

- Progression of unresectable locally advanced or metastatic breast cancer after last
systemic therapy (as confirmed by investigator), or be intolerant of last systemic
therapy

- Have measurable or non-measurable disease assessable by RECIST 1.1

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate hepatic and renal function

- Left ventricular ejection fraction (LVEF) ≥ 50%

- CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients
must have one of the following:

1. No evidence of brain metastases

2. Untreated brain metastases not needing immediate local therapy

3. Previously treated brain metastases not needing immediate local therapy

1. Brain metastases previously treated with local therapy may either be stable
since treatment or may have progressed since prior local CNS therapy

2. Patients treated with CNS local therapy for newly identified lesions found
on contrast brain MRI performed during screening for this study may be
eligible to enroll if the following criteria are met:

- Time since whole brain radiation therapy (WBRT) is ≥ 21 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 disease assessable by RECIST 1.1 are present

3. Relevant records of any CNS treatment must be available to allow for
classification of target and non-target lesions

Exclusion Criteria

- Previously been treated with:

1. 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 toxicity)

2. neratinib, afatinib, or other investigational HER2/epidermal growth factor
receptor (EGFR) tyrosine kinase inhibitor (TKI) at any time previously

3. capecitabine (or other fluoropyrimidine) for metastatic disease except in cases
where capecitabine was given for < 21 days and was discontinued for reasons other
than disease progression or toxicity. Patients who have received capecitabine for
adjuvant or neoadjuvant treatment at least 12 months prior to starting study
treatment are eligible.

- Clinically significant cardiopulmonary disease

- Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease

- Positive for human immunodeficiency virus (HIV)

- Unable for any reason to undergo MRI of the brain

- Have used a strong CYP3A4 or CYP2C8 inhibitor within 5 half-lives of the inhibitor, or
a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment

- CNS Exclusion - Based on screening brain MRI, patients must not have any of the
following:

1. Any untreated brain lesions > 2.0 cm in size, unless approved by medical monitor

2. Ongoing use of systemic 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. Patients who undergo
local treatment for such lesions identified by screening contrast brain MRI may
still be eligible for the study based on criteria described under CNS inclusion
criteria

4. Known or suspected leptomeningeal disease (LMD)

5. Poorly controlled seizures
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Washington, District of Columbia 20007
Principal Investigator: Paula Pohlmann
Phone: 202-444-2209
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Frances Valdes-Albini
Phone: 954-210-1171
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Vandana Abramson
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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Phone: 503-494-0543
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Alison Conlin
Phone: 503-215-2619
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Adam Cohen
Phone: 801-585-0303
University of Utah Research is a major component in the life of the U benefiting...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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Phone: 210-450-5962
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Hatem Soliman
Phone: 813-745-3007
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
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Atlanta, Georgia 30322
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Augusta, Georgia 30912
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Aurora, Colorado 80045
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Baltimore, Maryland 20742
(301) 405-1000
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Chapel Hill, North Carolina 27599
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1653 W. Congress Parkway
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1441 North Beckley Avenue
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1500 East Duarte Road
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626-256-HOPE (4673)
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2301 Erwin Rd
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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3840 Broadway
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Phone: 551-996-8258
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Heidelberg,
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Phone: 866-333-7436
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Hollywood, Florida 33021
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4321 Washington Street #4000
Kansas City, Missouri 64111
(816) 932-3300
Principal Investigator: Timothy Pluard
Phone: 816-932-2562
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Lebanon, New Hampshire 03756
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1660 Springhill Avenue
Mobile, Alabama 36604
(251) 665-8000
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333 Cedar Street
New Haven, Connecticut 06520
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New York, New York 10003
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1201 5th Avenue North
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Principal Investigator: Sharon Wilks
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Seattle, Washington 98109
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
(631) 638-1000
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Tualatin, Oregon 97062
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
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