Phase 2
Completed N=224
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
Breast Cancer · Hormone Receptor Positive Tumor · Early-Stage Breast Carcinoma
Source: ClinicalTrials.gov NCT02441946 ↗
Enrolled (actual)
224
Serious AEs
4.1%
Results posted
Jan 2018
Primary outcomePrimary: Percent Change From Baseline to 2 Weeks in Ki67 Expression — -92.86; -90.52; -62.78 Percent Change — p=<0.001
Summary
The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to 2 Weeks in Ki67 Expression |
-92.86; -90.52; -62.78 | <0.001 sig |
| SECONDARY Percentage of Participants With Pathologic Complete Response (pCR) |
3.7 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response |
53.6 | — |
| SECONDARY Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response |
46.4 | — |
| SECONDARY Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) |
-9.5; -7.6; -2.3; -3.2; -5.5; -0.3 | — |
| SECONDARY Pharmacokinetics (PK): Apparent Clearance of Abemaciclib |
24.0; 19.1; 24.4 | — |
| SECONDARY PK: Apparent Volume of Distribution of Abemaciclib |
941; 720; 758 | — |
Eligibility Criteria
Inclusion Criteria
- Have postmenopausal status.
- Adenocarcinoma of the breast.
- Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.
- Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.
- Primary breast cancer that is suitable for baseline core biopsy.
- Have adequate organ function.
Exclusion Criteria
- Bilateral invasive breast cancer.
- Metastatic breast cancer (local spread to axillary lymph nodes is permitted).
- Inflammatory breast cancer.
- Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.
- Prior radiotherapy to the ipsilateral chest wall for any malignancy.
- Prior anti-estrogen therapy.
Data sourced from ClinicalTrials.gov (NCT02441946). 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.