Clinical trial · Interventional
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic decision due to emerging new data for patients with HR+, HER2- metastatic breast cancer.
Summary
Brief summary (as posted)
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Nonsteroidal Aromatase Inhibitor (NSAI) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abemaciclib + NSAI
- description
- Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
- interventionNames
- Drug: Abemaciclib
- Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
Primary outcomes (2)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)
- description
- PFS
- measure
- Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
- timeFrame
- Baseline to Objective Disease Progression (Estimated up to 26 Months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis * Participants must have 1 or more of the following: * A high grade tumor in tissue * Negative progesterone receptor (PR) status * Have cancer that has spread to the liver * Have a treatment-free interval (TFI) \<36 months * Participants must have HR+, HER2- breast cancer * Participants must have adequate organ function Exclusion Criteria: * Participants must not have cancer that has spread to other organs that has severely affected their function * Participants must not have cancer that has spread to the brain that is unstable or untreated * Participants must not have received endocrine therapy in the metastatic setting * Participants must not have known active infection * Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment * Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 \& 6 inhibitor or everolimus
References
Publications (0)
Data not yet available