Phase 2
Completed N=43
A Study of LY573636-sodium in Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00992225 ↗Enrolled (actual)
43
Serious AEs
30.3%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With an Objective Overall Response — 6.1 percentage of participants
Summary
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Objective Overall Response |
6.1 | — |
| SECONDARY Progression-free Survival |
1.81 | — |
| SECONDARY Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)] |
9.1 | — |
| SECONDARY Duration of Overall Response |
— | — |
| SECONDARY Duration of Stable Disease |
3.52 | — |
| SECONDARY The Percentage of Participants With Exposures in the Target Range |
45; 52 | — |
| SECONDARY Maximum Concentration (Cmax) |
375; 339 | — |
Eligibility Criteria
Inclusion Criteria
- Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer.
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients who have received whole-brain radiation must wait 90 days.
Exclusion Criteria
- Serious pre-existing medical condition.
- Have active central nervous system or leptomeningeal metastasis.
- Current hematologic malignancies, acute or chronic leukemia.
- Receiving Warfarin (Coumadin).
- Have a history of radiation therapy involving more than 25% of the bone marrow.
Data sourced from ClinicalTrials.gov (NCT00992225). 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.