Phase 2
N=242
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Neoplasms, Breast
Bottom Line
View on ClinicalTrials.gov: NCT00263588 ↗Enrolled (actual)
242
Serious AEs
36.4%
Results posted
Dec 2019
Primary outcome: Primary: The Number of Participants With Central Nervous System (CNS) Best Overall Response — 0; 0; 6; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lapatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Central Nervous System (CNS) Best Overall Response |
0; 0; 6; 9; 40; 46 | — |
| PRIMARY The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR) |
6; 6 | — |
| SECONDARY Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet |
24; 8; 14; 9 | — |
| SECONDARY Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS) |
23; 14; 2; 8; 8; 11 | — |
| SECONDARY Duration of Central Nervous System (CNS) Objective Response |
2.43; 1.58 | — |
| SECONDARY Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy |
9; 2 | — |
| SECONDARY Time to Progression (TTP) at Any Site |
2.60; 1.87 | — |
| SECONDARY Overall Survival (OS) |
10.78; 5.82 | — |
| SECONDARY Summary of Site of First Progression |
69; 72; 1; 10; 12; 36 | — |
| SECONDARY Primary Cause of Death |
74; 124; 4; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00263588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.