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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00338247




Registration number
NCT00338247
Ethics application status
Date submitted
16/06/2006
Date registered
20/06/2006
Date last updated
6/04/2016

Titles & IDs
Public title
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
Scientific title
An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
EGF103659
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - lapatinib + capecitabine

Treatment: Drugs: lapatinib + capecitabine
Experimental
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion criteria:

* May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.
* Prior treatment with hormonal therapy is allowed.
* Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.
* Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
* Must be >/= 18 years of age
* Life expectancy of > 8 weeks
* Must have recovered from side effects of previous treatment
* Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required
* Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed
* Able to swallow and retain oral medications
* Must have adequate hematologic, hepatic and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Pregnant or lactating females
* Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis
* Concurrent disease or condition that would make the patient inappropriate for study participation
* Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment
* Uncontrolled infection
* Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient
* Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed
* History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients
* History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients
* Known DPD deficiency

Study design
Purpose of the study
Allocation to intervention
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?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
APPROVED_FOR_MARKETING
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [2] 0 0
Novartis Investigative Site - North Sydney
Recruitment hospital [3] 0 0
Novartis Investigative Site - Port Macquarie
Recruitment hospital [4] 0 0
Novartis Investigative Site - Waratah
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Novartis Investigative Site - Westmead
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Novartis Investigative Site - Herston
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Novartis Investigative Site - South Brisbane
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Novartis Investigative Site - Bedford Park
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Novartis Investigative Site - Hobart
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Novartis Investigative Site - Box Hill
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Novartis Investigative Site - Fitzroy
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Novartis Investigative Site - Geelong
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Novartis Investigative Site - Wodonga
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Novartis Investigative Site - Nedlands
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Novartis Investigative Site - Perth
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2217 - Kogarah
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2060 - North Sydney
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2444 - Port Macquarie
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2298 - Waratah
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2145 - Westmead
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4029 - Herston
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4101 - South Brisbane
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5042 - Bedford Park
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7000 - Hobart
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3128 - Box Hill
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3065 - Fitzroy
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3220 - Geelong
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3690 - Wodonga
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6009 - Nedlands
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6000 - Perth
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Shrewsbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies
Trial website
https://clinicaltrials.gov/study/NCT00338247
Trial related presentations / publications
Ro J, Park S, Kim S, Kim TY, Im YH, Rha SY, Chung JS, Moon H, Santillana S. Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine: an open-label expanded access study in Korea. BMC Cancer. 2012 Jul 28;12:322. doi: 10.1186/1471-2407-12-322.
Wang L, Zhang Q, Zhang J, Sun S, Guo H, Jia Z, Wang B, Shao Z, Wang Z, Hu X. PI3K pathway activation results in low efficacy of both trastuzumab and lapatinib. BMC Cancer. 2011 Jun 15;11:248. doi: 10.1186/1471-2407-11-248.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00338247