A Phase 2 interventional study of Alvespimycin in Breast Cancer, sponsored by Bristol-Myers Squibb. Terminated. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-04.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 4 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Alvespimycin
Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT
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
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment, and for 167 days
Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system
Time frame: 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
(all patients were off study by June 2008)
Time frame: 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
Karnofsky Performance Status
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days
Ocular testing
(all patients were off study by June 2008)
Time frame: 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
Kaplan-Meier estimate of time to progression
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of progression-free survival
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of time to response
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of duration of response
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of time to treatment failure
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Kaplan-Meier estimate of overall survival
(all patients were off study by June 2008)
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Changes in tumor markers
Time frame: 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
Time frame: Specimens were obtained within 28 days prior to the start of treatment
No study locations are listed for this record.
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb