Breast Cancer
Conditions
Brief summary
The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).
Interventions
DRUGAlvespimycin
Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* KPS performance status of \>= 80% (normal activity with effort) * Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry (IHC) * Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting * Measurable disease by RECIST Criteria
Exclusion criteria
* Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors * Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication * Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits * Moderately severe dry eye * Congestive heart failure, or a left ventricular ejection fraction * Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration * Previous malignancies unless free of recurrence for at least 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system | Within 10 days prior to Cycle 1/1st infusion; within 48 hours of infusion (Cycle 1/Weeks 2/3/4 and Cycle 2+/Week3), or within 72 hours prior to infusion (Cycle 2+/Week 1) | — |
| Vital signs | Within 28 days prior to the start of treatment, Day1 of Weeks 1, 2, and 3 of Cycle 1 (4 weeks long), and prior to each 4-week cycle starting with Cycle 2, for 167 days | (all patients were off study by June 2008) |
| Karnofsky Performance Status | Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days | (all patients were off study by June 2008) |
| Ocular testing | Within 28 days prior to the start of treatment, Cycle 1/Day 10 (3 days +/- 1 day following the 2nd infusion in the first cycle of therapy), prior to Cycle 2, if clinically indicated thereafter, for 167 days | (all patients were off study by June 2008) |
| Kaplan-Meier estimate of time to progression | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system | Within 28 days prior to the start of treatment, and for 167 days | (all patients were off study by June 2008) |
| Kaplan-Meier estimate of time to response | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Kaplan-Meier estimate of duration of response | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Kaplan-Meier estimate of time to treatment failure | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Kaplan-Meier estimate of overall survival | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
| Changes in tumor markers | Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days | — |
| Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens | Specimens were obtained within 28 days prior to the start of treatment | — |
| Kaplan-Meier estimate of progression-free survival | Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days) | (all patients were off study by June 2008) |
Outcome results
None listed