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Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Primary Purpose

Neoplasms, Breast

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lapatinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Breast focused on measuring breast cancer, brain metastases, ErbB2 positive, HER2 positive, neoplasms, cancer, lapatinib, LAP016A2202, LAP016A, CLAP016A2202, GW572016

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Signed Informed Consent ErbB2(HER2)overexpressing breast cancer. Brain lesion(s) which are progressing. Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS). Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy. Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram. Able to swallow an oral medication. Adequate kidney and liver function. Adequate bone marrow function. Exclusion criteria: Pregnant or lactating females. Conditions that would effect the absorption of an oral drug. History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents. Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel. Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

750 mg lapatinib administered orally twice daily

Outcomes

Primary Outcome Measures

The Number of Participants With Central Nervous System (CNS) Best Overall Response
Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS) A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms
The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)
Summary of CNS Objective Response (the Complete Response + Partial Response)

Secondary Outcome Measures

Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
Physician-reported NSS worksheet is derived from 13 AEs and measured by NCI CTCAE v3.0 grouped into 7 categories: level of consciousness, neurological symptoms, cranial nerves, language, strength, sensation, & ataxia. Improvement of NSS required: Decrease by 1 or more grades from baseline of any tumor-related NSS, with confirmation at least 4 wks later, No development or worsening in any tumor-related NSS during interval, No radiographic evidence of CNS progression (assessed by volumetric MRI) or systemic (non-CNS) progression (assessed by RECIST) during interval, Stable or decreasing steroids during interval as defined by GSK equivalent doses of an alternative corticosteroid or a dose increase for non-tumor related reasons didn't constitute a steroid increase. Improvement in any non-tumor associated NSS didn't constitute improvement in NSS. Neurological exam, using Neurological Examination Worksheet was assessed at baseline & each 4 wks. Categories below are not mutually exclusive.
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
Summary of Proportion of Subjects with a CNS Objective Response or Improvement in Baseline NSS
Duration of Central Nervous System (CNS) Objective Response
The duration of CNS objective response, defined as the time from first CNS Objective response until tumor progression at any site or death due to any cause. A CNS objective response was defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs or symptoms.
Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy
The CNS disease control rate, defined as the percentage of subjects with CR, PR or stable disease at Week 24
Time to Progression (TTP) at Any Site
Summary of Kaplan-Meier Estimates for Progression Free Survival at Any Site
Overall Survival (OS)
Overall survival (OS) defined as the time from initiation of investigational product to death due to any cause.
Summary of Site of First Progression
baseline to time of disease progression or death
Primary Cause of Death
Summary of Overall All-cause mortality (Main Study and Extension)

Full Information

First Posted
December 2, 2005
Last Updated
November 21, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00263588
Brief Title
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Official Title
A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2, 2005 (Actual)
Primary Completion Date
September 25, 2007 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Breast
Keywords
breast cancer, brain metastases, ErbB2 positive, HER2 positive, neoplasms, cancer, lapatinib, LAP016A2202, LAP016A, CLAP016A2202, GW572016

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
750 mg lapatinib administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
lapatinib
Intervention Description
tyrosine kinase inhibitor
Primary Outcome Measure Information:
Title
The Number of Participants With Central Nervous System (CNS) Best Overall Response
Description
Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS) A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Title
The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)
Description
Summary of CNS Objective Response (the Complete Response + Partial Response)
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
Description
Physician-reported NSS worksheet is derived from 13 AEs and measured by NCI CTCAE v3.0 grouped into 7 categories: level of consciousness, neurological symptoms, cranial nerves, language, strength, sensation, & ataxia. Improvement of NSS required: Decrease by 1 or more grades from baseline of any tumor-related NSS, with confirmation at least 4 wks later, No development or worsening in any tumor-related NSS during interval, No radiographic evidence of CNS progression (assessed by volumetric MRI) or systemic (non-CNS) progression (assessed by RECIST) during interval, Stable or decreasing steroids during interval as defined by GSK equivalent doses of an alternative corticosteroid or a dose increase for non-tumor related reasons didn't constitute a steroid increase. Improvement in any non-tumor associated NSS didn't constitute improvement in NSS. Neurological exam, using Neurological Examination Worksheet was assessed at baseline & each 4 wks. Categories below are not mutually exclusive.
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Title
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
Description
Summary of Proportion of Subjects with a CNS Objective Response or Improvement in Baseline NSS
Time Frame
baseline and weeks 8, 16, 24, 32, 40, 48
Title
Duration of Central Nervous System (CNS) Objective Response
Description
The duration of CNS objective response, defined as the time from first CNS Objective response until tumor progression at any site or death due to any cause. A CNS objective response was defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs or symptoms.
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Title
Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy
Description
The CNS disease control rate, defined as the percentage of subjects with CR, PR or stable disease at Week 24
Time Frame
from Start of lapatinib to 6 months
Title
Time to Progression (TTP) at Any Site
Description
Summary of Kaplan-Meier Estimates for Progression Free Survival at Any Site
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Title
Overall Survival (OS)
Description
Overall survival (OS) defined as the time from initiation of investigational product to death due to any cause.
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Title
Summary of Site of First Progression
Description
baseline to time of disease progression or death
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Title
Primary Cause of Death
Description
Summary of Overall All-cause mortality (Main Study and Extension)
Time Frame
time from baseline to data cutoff (25 Sept 2007); approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Signed Informed Consent ErbB2(HER2)overexpressing breast cancer. Brain lesion(s) which are progressing. Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS). Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy. Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram. Able to swallow an oral medication. Adequate kidney and liver function. Adequate bone marrow function. Exclusion criteria: Pregnant or lactating females. Conditions that would effect the absorption of an oral drug. History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents. Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel. Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Novartis Investigative Site
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Novartis Investigative Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Novartis Investigative Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Novartis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Novartis Investigative Site
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Novartis Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Novartis Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Novartis Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Novartis Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Novartis Investigative Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Novartis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novartis Investigative Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Novartis Investigative Site
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Novartis Investigative Site
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Novartis Investigative Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Novartis Investigative Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Novartis Investigative Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novartis Investigative Site
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Novartis Investigative Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Novartis Investigative Site
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Novartis Investigative Site
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Novartis Investigative Site
City
Paris Cedex 05
ZIP/Postal Code
75248
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse cedex
ZIP/Postal Code
31052
Country
France
Facility Name
Novartis Investigative Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80637
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Neo Faliro
ZIP/Postal Code
18547
Country
Greece
Facility Name
Novartis Investigative Site
City
Bangalore
ZIP/Postal Code
560078
Country
India
Facility Name
Novartis Investigative Site
City
Mumbai
ZIP/Postal Code
400026
Country
India
Facility Name
Novartis Investigative Site
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Facility Name
Novartis Investigative Site
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Novartis Investigative Site
City
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Novartis Investigative Site
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Novartis Investigative Site
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Locarno
ZIP/Postal Code
6600
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Tainan County
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
20179708
Citation
Sutherland S, Ashley S, Miles D, Chan S, Wardley A, Davidson N, Bhatti R, Shehata M, Nouras H, Camburn T, Johnston SR. Treatment of HER2-positive metastatic breast cancer with lapatinib and capecitabine in the lapatinib expanded access programme, including efficacy in brain metastases--the UK experience. Br J Cancer. 2010 Mar 16;102(6):995-1002. doi: 10.1038/sj.bjc.6605586. Epub 2010 Feb 23.
Results Reference
result

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Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

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