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Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00263588
First received: December 2, 2005
Last updated: June 6, 2017
Last verified: June 2017
December 2, 2005
June 6, 2017
December 2, 2005
December 31, 2018   (Final data collection date for primary outcome measure)
Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. [ Time Frame: baseline to time of best response to treatment ]
To determine the response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.
Complete list of historical versions of study NCT00263588 on ClinicalTrials.gov Archive Site
  • Improvement in neurological signs and symptoms (NSS), measured using the Neurological Examination Worksheet [ Time Frame: baseline to end of treatment ]
  • Percentage of patients who obtain a CNS objective response or improvement in baseline NSS [ Time Frame: baseline to end of treatment ]
  • Duration of CNS objective response [ Time Frame: baseline to end of treatment ]
  • Percentage of patients with CNS disease control (complete response, partial response or stable disease) at 6 months of lapatinib therapy [ Time Frame: baseline to end of treatment ]
  • Time to progression at any site [ Time Frame: baseline to time of disease progression ]
  • Overall survival [ Time Frame: baseline to time of death or lost ot follow up ]
  • Site of first progression and cause of death [ Time Frame: baseline to time of death or lost ot follow up ]
  • Qualitative and quantitative toxicities associated with oral lapatinib, given at a dose of 750 mg twice a day [ Time Frame: baseline to end of treatment ]
  • Relationship of PET uptake at Baseline and Week 1, as predictors of response (for those patients whose site obtained PET qualifications). [ Time Frame: baseline to end of treatment ]
  • Relationship between genetic variants in select candidate genes in the host and the efficacy and safety of lapatinib [ Time Frame: baseline to end of treatment ]
No secondary outcomes
Not Provided
Not Provided
 
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
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.
Not Provided
Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms, Breast
Drug: lapatinib
tyrosine kinase inhibitor
Experimental: single arm
750 mg laptinib administered orally twice daily
Intervention: Drug: lapatinib
Lin NU, Diéras V, Paul D, Lossignol D, Christodoulou C, Stemmler HJ, Roché H, Liu MC, Greil R, Ciruelos E, Loibl S, Gori S, Wardley A, Yardley D, Brufsky A, Blum JL, Rubin SD, Dharan B, Steplewski K, Zembryki D, Oliva C, Roychowdhury D, Paoletti P, Winer EP. Multicenter phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer. Clin Cancer Res. 2009 Feb 15;15(4):1452-9. doi: 10.1158/1078-0432.CCR-08-1080.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
244
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Greece,   India,   Italy,   Japan,   Poland,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
 
 
NCT00263588
EGF105084
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
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

Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP