Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT00263588

Acronym / sponsor ID

EGF105084

Conditions

Neoplasms, Breast

Keywords

breast cancer, brain metastases, ErbB2 positive, HER2 positive, neoplasms, cancer, lapatinib, LAP016A2202

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

242 participants (actual)

Lead sponsor

Novartis PharmaceuticalsIndustry (pharma, biotech, devices)

Study start

2 Dec 2005 (actual)

Primary completion

25 Sep 2007 (actual)

Study completion

15 Mar 2018 (actual)

First posted

9 Dec 2005 (estimated)

Results

Posted 12 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. The Number of Participants With Central Nervous System (CNS) Best Overall Response

   Time frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years

   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

2. The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)

   Time frame: time from baseline to data cutoff (25 Sept 2007); approximately 2 years

   Summary of CNS Objective Response (the Complete Response + Partial Response)

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Results publication: PubMed 20179708Sutherland 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.
• Individual participant dataSharing planned: Undecided. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

74 sites in 17 countries: see every site and its status.