Status:
TERMINATED
Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy
Lead Sponsor:
Gary Schwartz
Collaborating Sponsors:
University of Colorado, Denver
North Shore University Hospital
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Two thirds or more of breast cancers are dependent on estrogen for growth. We use a number of estrogen-blocking medicines for treatment of metastatic breast cancer. The treatment response to these age...
Detailed Description
All patients must have stopped their endocrine two to four weeks or longer prior to entry on study. Upon enrollment, patients will begin lapatinib at 1500 mg once a day orally. The original endocrine ...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically proven metastatic breast cancer.
- Patients with either estrogen or progesterone receptor positivity on the most recently examined tumor biopsy.
- Patients must have most recently been using an anti-estrogen (tamoxifen, toremifene, raloxifene, or fulvestrant) or an aromatase inhibitor.
- Patients must have had either a partial response or better, or stable disease for 24 weeks or longer, followed by disease progression, on the current or most recent hormonal therapy for management of metastatic breast cancer.
- Patients must be enrolled within six weeks of defining disease progression on hormonal therapy.
- Patients must have stopped fulvestrant at least four weeks prior and other endocrine therapy at least two weeks prior to enrollment on study.
- Patients must have either measurable disease or at least one evaluable bone lesion that has not been irradiated. Measurable disease is not necessary.
- Estimated life expectancy of at least 6 months.
- ECOG performance status 0-2.
- Adequate hematologic, hepatic, and renal function.
- Patients must be post-menopausal, or they must be practicing either abstinence or an adequate method of contraception, or their sexual partner must be sterile.
- All patients must be able to swallow, retain, and absorb oral medications.
- All patients must be able to give informed consent indicating that they are aware of the investigational nature of this study.
Exclusion
- Patients may not have received an investigational agent within the prior four weeks.
- Patients may not have received trastuzumab within three weeks of study entry.
- Patients may not have had major surgery within the prior two weeks.
- Patients may not have Class III or IV heart failure as defined by the NYHA functional classification system.
- Patients may not have a left ventricular ejection fraction \< 40% based on MUGA or echocardiogram.
- Patients may not have uncontrolled brain metastases or leptomeningeal disease.
- Patients may not have rapidly progressive visceral metastases.
- Patients may not have a serious illness or conditions including clinically significant cardiac disease, angina pectoris, serious psychiatric disorder, or an active infection.
- Patients may not be receiving concurrent medications (listed in the protocol) which may interact with lapatinib during treatment with lapatinib.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00225758
Start Date
January 1 2006
End Date
October 1 2011
Last Update
July 27 2018
Active Locations (3)
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1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
2
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
3
North Shore University Hospital
Lake Success, New York, United States, 11042