Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2018 |
| Start Date: | December 2, 2005 |
| End Date: | March 15, 2018 |
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.
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.
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.
We found this trial at
26
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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