metastatic breast cancer
Conditions
Brief summary
Progression Free Survival (PFS), as per investigator’s assessment (PFS defined as time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first)
Detailed description
Objective Response Rate (ORR): proportion of patients who achieve a best overall response (BOR) of partial response (PR) or complete response (CR), Duration of Response (DoR): time from the date of first documented CR/PR until the first radiological documentation of disease progression or death, whichever comes first, Clinical Benefit Rate (CBR): proportion of patients who achieve a BOR of confirmed CR/PR or durable stable disease (duration at least 24 weeks from date of first dose), Overall Survival (OS): time from the date of the first dose to the date of death from any cause
Interventions
Sponsors
Stemline Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS), as per investigator’s assessment (PFS defined as time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR): proportion of patients who achieve a best overall response (BOR) of partial response (PR) or complete response (CR), Duration of Response (DoR): time from the date of first documented CR/PR until the first radiological documentation of disease progression or death, whichever comes first, Clinical Benefit Rate (CBR): proportion of patients who achieve a BOR of confirmed CR/PR or durable stable disease (duration at least 24 weeks from date of first dose), Overall Survival (OS): time from the date of the first dose to the date of death from any cause | — |
Countries
Bulgaria, Romania
Outcome results
None listed