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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00667251




Registration number
NCT00667251
Ethics application status
Date submitted
25/04/2008
Date registered
28/04/2008

Titles & IDs
Public title
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
Scientific title
A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer
Secondary ID [1] 0 0
CLAP016A2303
Secondary ID [2] 0 0
108919
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - trastuzumab
Treatment: Drugs - docetaxel
Treatment: Drugs - lapatinib ditosylate
Treatment: Drugs - paclitaxel

Active comparator: Lapatinib - Plus taxane based chemotherapy

Active comparator: Trastuzumab - Plus taxane based chemotherapy.


Treatment: Other: trastuzumab
IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).

Treatment: Drugs: docetaxel
75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).

Treatment: Drugs: lapatinib ditosylate
1250 mg po daily (while given with taxane). 1500mg PO daily (when given alone after taxane completion).

Treatment: Drugs: paclitaxel
80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
From randomization to RECIST V 1.0 progression or death assessed up to 39 months.
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization to death from any cause, assessed up to 44 months.
Secondary outcome [2] 0 0
Time to CNS Metastases at the Time of First Progression
Timepoint [2] 0 0
From randomization to CNS metastases at time of first progression, assessed up to 39 months.
Secondary outcome [3] 0 0
CNS Metastases at the Time of Progression (ITT)
Timepoint [3] 0 0
Incidence rate of CNS metastases at first progression assessed up to 39 months
Secondary outcome [4] 0 0
CNS Metastases at the Time of Progression (HER2+)
Timepoint [4] 0 0
Incidence rate of CNS mestastes at first progression, assessed up to 39 months
Secondary outcome [5] 0 0
Overall Objective Response Rate (Complete or Partial) ITT
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Overall Objective Response Rate (Complete or Partial) HER2/Neu+
Timepoint [6] 0 0
Median follow-up of 21.5 months.
Secondary outcome [7] 0 0
Clinical Benefit Response Rate (ITT)
Timepoint [7] 0 0
24 weeks
Secondary outcome [8] 0 0
Clinical Benefit Response Rate (HER2/Neu+))
Timepoint [8] 0 0
24 weeks
Secondary outcome [9] 0 0
Quality of Life as Measured by the EORTC QLQ-C30 Global Score From Baseline to 12 Weeks
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Effects of Changes in Biomarkers on Clinical Outcomes
Timepoint [10] 0 0
Not available at this time
Secondary outcome [11] 0 0
Economic Evaluation, Including Health Utilities, as Measured by the EQ-5D Questionnaire, and Healthcare Utilization
Timepoint [11] 0 0
Not available at this time

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the breast
* Metastatic (stage IV) disease at primary diagnosis or at relapse after curative intent therapy
* Local or central laboratory confirmedHER2/neu* overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion as defined by the following:

* 3+ overexpression (in > 30% of invasive tumor cells) by immunohistochemistry (IHC)
* 2+ or 3+ overexpression (in = 30% of invasive tumor cells) by IHC AND demonstrates HER2/neu gene amplification by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
* HER2/neu gene amplification by FISH/CISH (> 6 HER2/neu gene copies per nucleus, or a FISH/CISH ratio [HER2 gene copies to chromosome 17 signals] of = 2.2) NOTE: *Patients with a negative or equivocal overall result (FISH/CISH ratio of < 2.2, = 6.0 HER2/neu gene copies per nucleus, or staining scores of 0, 1+, 2+, or 3+ [in = 30% of neoplastic cells] by IHC) are not eligible
* Formalin-fixed paraffin-embedded tumor specimen available
* No CNS metastases (including leptomeningeal involvement)
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* ECOG performance status 0-2
* Life expectancy > 6 months
* Absolute granulocyte count > 1,500/mm³
* Platelet count > 75,000/mm³
* Hemoglobin > 10 g/dL
* Serum creatinine = 2.0 times upper limit of normal (ULN)
* Total bilirubin = 1.5 times ULN (< 3 times ULN for patients with Gilbert's disease)
* AST and/or ALT = 2.5 times ULN (< 5 times ULN for patients planning to receive paclitaxel-based therapy)
* LVEF = 50% by MUGA or ECHO
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be accessible for study treatment and follow-up
* No history of other malignancies, except adequately treated ductal carcinoma in situ or lobular carcinoma in situ, adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor (non-breast) with no evidence of disease for = 5 years
* No serious cardiac illness or condition including, but not limited to, any of the following:

* History of documented congestive heart failure
* Systolic dysfunction (LVEF < 50%)
* High-risk uncontrolled arrhythmias (i.e., ventricular tachycardia, high-grade atrioventricular block, or supraventricular arrhythmias that are not adequately rate-controlled)
* Unstable angina pectoris requiring anti-anginal medication
* Clinically significant valvular heart disease
* Evidence of transmural infarction on ECG
* Inadequately controlled hypertension (i.e., systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg)
* New York Heart Association class III-IV functional status
* No serious illness or medical condition that would not allow the patient to be managed according to the protocol including, but not limited to, any of the following:

* History of significant neurologic or psychiatric disorder that would impair the ability to obtain informed consent or limit compliance with study requirements
* Active uncontrolled infection
* Serious or nonhealing wound, ulcer, or bone fracture
* No peripheral neuropathy = grade 2
* No gastrointestinal (GI) tract disease resulting in an inability to take oral medication including, but not limited to, any of the following:

* Malabsorption syndrome
* Requirement for IV alimentation
* Uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
* No history of allergic or hypersensitivity reactions to any study drug or their excipients or to compounds with similar chemical composition to any of the study drugs

* Prior allergic reactions to taxanes are allowed provided they were adequately treated and, according to the treating physician, would not prohibit further treatment with taxanes

PRIOR CONCURRENT THERAPY:

* Recovered from all prior therapy
* No prior chemotherapy, immunotherapy, biological therapy, or anti-HER2/neu-targeted therapy for recurrent or metastatic breast cancer
* At least 12 months since prior chemotherapeutic agents, including taxanes, in the neoadjuvant or adjuvant setting
* At least 12 months since prior anti-HER2/neu-targeted therapy in the neoadjuvant or adjuvant setting
* Prior treatment with endocrine therapy in the neoadjuvant, adjuvant, or metastatic setting allowed
* At least 2 weeks since prior radiotherapy in the adjuvant or metastatic setting

* Prior radiotherapy to a solitary metastatic lesion allowed provided there is documented disease progression after completion of radiotherapy
* More than 30 days (or 5 half-lives) since prior investigational drugs
* At least 7 days since prior and no concurrent CYP3A4 inhibitors (6 months for amiodarone)
* At least 14 days since prior and no concurrent CYP3A4 inducers
* No prior surgical procedures affecting absorption (e.g., resection of stomach or small bowel)
* No concurrent palliative radiotherapy
* No other concurrent anticancer treatment
* No other concurrent investigational drugs for breast cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
7/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/07/2022
Sample size
Target
Accrual to date
Final
652
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Garran
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - North Sydney
Recruitment hospital [4] 0 0
Novartis Investigative Site - Tweed Heads
Recruitment hospital [5] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [6] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [7] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [8] 0 0
Novartis Investigative Site - Kurralta Park
Recruitment hospital [9] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [10] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [11] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [12] 0 0
Novartis Investigative Site - Wodonga
Recruitment hospital [13] 0 0
Novartis Investigative Site - Subiaco
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2060 - North Sydney
Recruitment postcode(s) [4] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3690 - Wodonga
Recruitment postcode(s) [13] 0 0
6008 - Subiaco
Recruitment outside Australia
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United States of America
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Alaska
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Arizona
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Illinois
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Indiana
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Maryland
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Montana
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Nebraska
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New Jersey
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India
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Nagpur
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Pune
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Beer-Sheva
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Holon
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Petah-Tikva
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Poriya
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Ramat Gan
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Italy
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Friuli-Venezia-Giulia
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Italy
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Lazio
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Italy
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Liguria
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Puglia
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Songpa-gu, Seoul
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Pozuelo De Alarcon (Madrid)
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Valencia
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiangmai
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Ukraine
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Dnepropetrovsk
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Ukraine
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Dnipropetrovsk
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Ukraine
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Lviv
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Ukraine
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Sumy
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United Kingdom
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Bournemouth
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Brighton
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Chelmsford
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Cheltenham
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United Kingdom
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Colchester
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United Kingdom
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Cottingham, Hull
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United Kingdom
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Derby
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United Kingdom
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Edmonton
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United Kingdom
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Guildford
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United Kingdom
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Harrogate
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United Kingdom
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Huddersfield
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Norwich
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United Kingdom
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Nottingham
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United Kingdom
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Oxford
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United Kingdom
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Poole, Dorset
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United Kingdom
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Sheffield
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United Kingdom
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Shrewsbury
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United Kingdom
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Sutton
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United Kingdom
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Whitchurch, Cardiff
Country [159] 0 0
United Kingdom
State/province [159] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NCIC Clinical Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/study/NCT00667251