apatinib Pre-Surgical Phase 2 Study in Patients with Primary Breast Cancer
- Conditions
- Patients with primary breast cancer and new primary or recurrent breast cancer
- Registration Number
- EUCTR2006-001055-35-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
-Patients must have histologically or cytologically confirmed primary breast cancer, or new primary, or recurrent.
-The carcinoma can be ER positive or ER negative and must be EGFR positive as defined by positive immuno-staining with antibodies agains EGFR.
- 2 cohorts of patients will be enrolled. Patients in the control arm will be ER+, EGFR+ and patients in the experimental arm will be ER-ve, EGFR+ve. All patients will be erbB2 negative.
-Patients must have measurable breast cancer, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10mm with ultrasound.
-No prior chemotherapy for breast cancer if given less than two years ago.
- Age > or = to 18 years.
- Life expectancy of greater than 12 weeks
--ECOG performance status 2
- Patients must have normal organ and marrow function as defined in the protocol.
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram.
- Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of Lapatinib will be determined following review of their use by the Principal Investigator.
- Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Able to give written informed consent.
- Able to swallow and retain oral medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Patients who have had any chemotherapy within the last 2 years.
- Patients who have had prior treatment with EGFR targeting therapies.
- Patients with metastatic disease.
- Patients with erbB2+++
- Patients who have rapidly progressive local disease, or local disease that, in the opinion of the investigator, is not amenable to surgical resection.
- Pregnant women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of tumour response to treatment with Lapatinib;<br> Secondary Objective: -Assessment of intra-tumoural biomarkers before and at the end of Lapatinib treatment.<br> - Safety.<br> ;Primary end point(s): RECIST response by ultrasound measurement.
- Secondary Outcome Measures
Name Time Method