Phase 2
Completed N=132
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
Source: ClinicalTrials.gov NCT02102490 ↗Enrolled (actual)
132
Serious AEs
25.0%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) — 19.7 Percentage of participants
Summary
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
19.7 | — |
| SECONDARY Overall Survival (OS) |
22.32 | — |
| SECONDARY Duration of Response (DOR) |
8.6 | — |
| SECONDARY Progression Free Survival (PFS) |
6.0 | — |
| SECONDARY Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR]) |
67.4 | — |
| SECONDARY Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) |
42.4 | — |
| SECONDARY Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score |
18; 21; 20 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 |
3510; 1620; 2750 | — |
| SECONDARY Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score |
17; 16; 26 | — |
Eligibility Criteria
Inclusion Criteria.
- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
- Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
- Prior treatment with at least 2 chemotherapy regimens:
- At least 1 of these regimens must have been administered in the metastatic setting.
- At least 1 of these regimens must have contained a taxane.
- No more than 2 prior chemotherapy regimens in the metastatic setting.
- Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
- Have discontinued all previous therapies for cancer.
- Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.
Exclusion Criteria
- Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
- Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
- Have had major surgery within 14 days of the initial dose of study drug.
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
Data sourced from ClinicalTrials.gov (NCT02102490). 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.