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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02614794




Registration number
NCT02614794
Ethics application status
Date submitted
20/11/2015
Date registered
25/11/2015
Date last updated
14/08/2023

Titles & IDs
Public title
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
Scientific title
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
Secondary ID [1] 0 0
2015-002801-12
Secondary ID [2] 0 0
ONT-380-206
Universal Trial Number (UTN)
Trial acronym
HER2CLIMB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - tucatinib
Treatment: Drugs - capecitabine
Treatment: Drugs - trastuzumab
Treatment: Drugs - placebo

Experimental: Tucatinib in combination with capecitabine & trastuzumab - Tucatinib + capecitabine + trastuzumab

Active Comparator: Placebo in combination with capecitabine & trastuzumab - Placebo + capecitabine + trastuzumab


Treatment: Drugs: tucatinib
300 mg orally twice daily

Treatment: Drugs: capecitabine
1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle

Treatment: Drugs: trastuzumab
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle. In regions where approved, trastuzumab may be given at 600mg subcutaneously once every 3-weeks at either study initiation or crossing over from previous IV trastuzumab.

Treatment: Drugs: placebo
Oral dose twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
34.6 months
Secondary outcome [1] 0 0
PFS in Patients With Brain Metastases at Baseline Using RECIST 1.1 as Determined by BICR
Timepoint [1] 0 0
34.6 months
Secondary outcome [2] 0 0
Overall Survival (OS) at Time of Primary Analysis
Timepoint [2] 0 0
35.9 months
Secondary outcome [3] 0 0
Confirmed Objective Response Rate (ORR) Per RECIST 1.1 as Determined by BICR
Timepoint [3] 0 0
34.6 months
Secondary outcome [4] 0 0
ORR Per RECIST 1.1 as Determined by Investigator Assessment
Timepoint [4] 0 0
34.6 months
Secondary outcome [5] 0 0
PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Primary Analysis
Timepoint [5] 0 0
34.6 months
Secondary outcome [6] 0 0
Duration of Response (DOR) Per RECIST 1.1 as Determined by BICR
Timepoint [6] 0 0
24.6 months
Secondary outcome [7] 0 0
DOR Per RECIST 1.1 as Determined by Investigator Assessment
Timepoint [7] 0 0
33.2 months
Secondary outcome [8] 0 0
Clinical Benefit Rate (CBR) as Determined by BICR Per RECIST 1.1
Timepoint [8] 0 0
34.6 months
Secondary outcome [9] 0 0
CBR Per RECIST 1.1 as Determined by Investigator Assessment
Timepoint [9] 0 0
34.6 months
Secondary outcome [10] 0 0
Incidence of Adverse Events (AEs) at Time of Primary Analysis
Timepoint [10] 0 0
36.1 months
Secondary outcome [11] 0 0
Frequency of Dose Modifications
Timepoint [11] 0 0
35.1 months
Secondary outcome [12] 0 0
Incidence of Health Resources Utilization
Timepoint [12] 0 0
36.1 months
Secondary outcome [13] 0 0
Pharmacokinetic Measure: Ctrough of Tucatinib
Timepoint [13] 0 0
3.5 months
Secondary outcome [14] 0 0
Pharmacokinetic Measure: ONT-993
Timepoint [14] 0 0
3.5 months
Secondary outcome [15] 0 0
Overall Survival (OS) at Time of Final Analysis
Timepoint [15] 0 0
Up to 60.1 months
Secondary outcome [16] 0 0
PFS Per RECIST 1.1 as Determined by Investigator Assessment at Time of Final Analysis
Timepoint [16] 0 0
Up to 58.0 months
Secondary outcome [17] 0 0
Incidence of Adverse Events (AEs) at Time of Final Analysis
Timepoint [17] 0 0
Up to 60.1 months
Secondary outcome [18] 0 0
Frequency of Dose Modifications at Time of Final Analysis
Timepoint [18] 0 0
Up to 60.1 months

Eligibility
Key inclusion criteria
Double-blind Phase Inclusion Criteria

- Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ
hybridization (ISH), immunohistochemistry (IHC), 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 and hematologic parameters

- 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:

i. 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.

ii. Other sites of disease assessable by RECIST 1.1 are present

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

Double-blind Phase
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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) or HER2 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

- Have known dihydropyrimidine dehydrogenase deficiency (DPD)

- 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 Unblinded Phase Crossover Inclusion Criteria -
Participants who were randomized to the control arm (placebo + trastuzumab +
capecitabine) must meet the following criteria to be eligible to crossover to the
experimental arm.

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

- For patients who were randomized to the control arm and on the long-term follow-up
period at the time of crossover screening: have 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 an ECOG Performance Status of 0 or 1

- Have a life expectancy of at least 6 months

- Have adequate hepatic and renal function and hematologic parameters

- Left ventricular ejection fraction (LVEF) = 50%

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

i. No evidence of brain metastases ii. Untreated brain metastases not needing
immediate local therapy iii. Previously treated brain metastases not needing immediate
local therapy

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

- 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:

1. 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.

2. Other sites of disease assessable by RECIST 1.1 are present Unblinded Phase
Crossover Exclusion Criteria - Participants who were randomized to the control
arm (placebo + trastuzumab + capecitabine) will be excluded from the crossover to
the experimental arm for any of the following reasons.

- Discontinuation of study treatment due to an adverse event while on the double-blind
phase of the study. If the adverse event leading to discontinuation of study treatment
has resolved, the patient may be allowed to crossover with approval from the medical
monitor.

- History of exposure to the following cumulative doses of anthracyclines:

- Doxorubicin > 360 mg/m^2

- Epirubicin > 720 mg/m^2

- Mitoxantrone > 120 mg/m^2

- Idarubicin > 90 mg/m^2

- Liposomal doxorubicin > 550 mg/m^2

- History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or
biologically similar to tucatinib

o Exceptions for Grade 1 or 2 infusion related reactions to trastuzumab that were
successfully managed, or known allergy to one of the excipients in the study drugs

- Have received treatment with any systemic anti-cancer therapy, non-CNS radiation, or
experimental agent within 3 weeks prior to start of crossover therapy

- Any toxicity related to prior cancer therapies that has not resolved to = Grade 1,
with the following exceptions:

- Alopecia and neuropathy (must have resolved to = Grade 2)

- CHF (must have been = Grade 1 in severity at the time of occurrence and must have
resolved completely)

- Anemia (must have resolved to = Grade 2)

- Have clinically significant cardiopulmonary disease

- Have known myocardial infarction or unstable angina within 6 months prior to start of
crossover therapy

- Require therapy with warfarin or other coumarin derivatives

- Inability to swallow pills or significant gastrointestinal disease which would
preclude the adequate oral absorption of medications

- Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor or have used
a strong CYP2C8 or CYP34A inducer within 5 days prior to start of the crossover
(tucatinib) treatment.

- Known dihydropyrimidine dehydrogenase deficiency

- Unable to undergo contract MRI of the brain

- Have evidence within 2 years prior to start of crossover therapy of another malignancy
that required systemic treatment

- CNS Exclusion:

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

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

- Ongoing use of systemic corticosteroids for control of symptoms of brain
metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)

- 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

- Known or suspected leptomeningeal disease (LMD)

- Poorly controlled seizures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/08/2022
Sample size
Target
Accrual to date
Final
612
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Cabrini Education and Research Precinct - Malvern
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Breast Cancer Research Centre - Nedlands
Recruitment hospital [5] 0 0
Mater Hospital - North Sydney
Recruitment hospital [6] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [7] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [8] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2060 - North Sydney
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment postcode(s) [8] 0 0
2145 - Westmead
Recruitment outside Australia
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Seagen Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.

There are two parts to this study. The first part of the study is already complete. Patients
were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since
this part was "blinded," neither patients nor their doctors knew whether a patient got
tucatinib or placebo.

The second part of the study is called the Unblinded Phase. In this part of the study,
participants and their doctors know which drugs are being given. Participants who used to get
or are currently getting placebo may be able to start taking tucatinib instead.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02614794
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jorge Ramos, DO
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT02614794