Clinical trial · Interventional
Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer
Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer
NCT00780000CI-TRIAL-00019707terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alvespimycin | Drug | Alvespimycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A1
- interventionNames
- Drug: Alvespimycin
Primary outcomes (1)
- measure
- 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
- timeFrame
- Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
- description
- (all patients were off study by June 2008)
Secondary outcomes (14)
- measure
- Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system
- timeFrame
- Within 28 days prior to the start of treatment, and for 167 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 yearsReferences
Publications (0)
Data not yet available
No reference posted for this study.