Clinical trial · Interventional
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
NCT02102490CI-TRIAL-00042876MONARCH 1completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abemaciclib
- description
- 200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
- interventionNames
- Drug: Abemaciclib
Primary outcomes (1)
- measure
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
- timeFrame
- From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
- description
- ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTDickler MN, Tolaney SM, Rugo HS, Cortes J, Dieras V, Patt D, Wildiers H, Hudis CA, O'Shaughnessy J, Zamora E, Yardley DA, Frenzel M, Koustenis A, Baselga J. MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR+/HER2- Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 1;23(17):5218-5224. doi: 10.1158/1078-0432.CCR-17-0754. Epub 2017 May 22. PMID 28533223