Phase 2
Completed N=22
Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01273896 ↗Enrolled (actual)
22
Serious AEs
27.3%
Results posted
Nov 2015
Primary outcomePrimary: Overall Response Rate — 20 participants
Summary
The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the patient and their breast cancer.
STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not yet approved for the treatment of cancer by the United States (FDA) Food and Drug Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose for this drug has been found. We are now interested to see how active this drug is against breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
20 | — |
Eligibility Criteria
Inclusion Criteria
- Male and Female patients must be at least 18 years of age
- Pathologically confirmed diagnosis of breast cancer
- Metastatic or advanced stage breast cancer
- Prior treatment with at least one and no more than three lines of biologic and/or chemotherapy for metastatic breast cancer (excluding hormonal therapy)
- Patients with HER2+ disease must have received prior treatment with Trastuzumab
- Patients with ER and/or PR+ disease must have received prior treatment with hormonal therapy
- Off cytotoxic chemotherapy or biologic therapy (excluding Hormonal therapy) ≥ 3 weeks
- Measurable disease by RECIST 1.1
- Central nervous system metastases are permitted if treated and radiographically and clinically stable for at least 4 weeks prior to first dose of STA-9090
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Life expectancy of at least 3 months
- Adequate hematologic function as defined by:
- Absolute neutrophil count ≥1,500 cells/μL
- Platelets ≥100,000/μL
- Hemoglobin ≥ 9.0g/dL
- Adequate hepatic function as defined by:
- Serum bilirubin ≤ 1.5 X upper limit of normal (ULN);
- Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN
- AST, ALT, and alkaline phosphatase ≤ 3 × ULN except for:
- Patients with hepatic metastases: ALT and AST ≤ 5 × ULN
- Patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × ULN
- Patients with Gilbert's disease: serum bilirubin 470 msec
- Ventricular ejection fraction (EF) 1 grade 1 in severity
- history of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
- history of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block
- New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers or diuretics
Data sourced from ClinicalTrials.gov (NCT01273896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.