Clinical trial · Interventional
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
- 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 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hormone Receptor Positive Tumor | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Anastrozole | Drug | Anastrozole | ALIAS |
| Loperamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Abemaciclib + Anastrozole
- description
- Abemaciclib (150 milligrams \[mg\]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
- interventionNames
- Drug: Abemaciclib
- Drug: Loperamide
- Drug: Anastrozole
- type
- EXPERIMENTAL
- label
- Abemaciclib
- description
- Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.
- interventionNames
- Drug: Abemaciclib
- Drug: Loperamide
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDFranzoi MA, Lambertini M, Ceppi M, Bruzzone M, de Azambuja E. Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients. Breast Cancer Res Treat. 2022 Apr;192(2):457-462. doi: 10.1007/s10549-022-06525-3. Epub 2022 Jan 25. PMID 35076812
- DERIVEDHurvitz SA, Martin M, Press MF, Chan D, Fernandez-Abad M, Petru E, Rostorfer R, Guarneri V, Huang CS, Barriga S, Wijayawardana S, Brahmachary M, Ebert PJ, Hossain A, Liu J, Abel A, Aggarwal A, Jansen VM, Slamon DJ. Potent Cell-Cycle Inhibition and Upregulation of Immune Response with Abemaciclib and Anastrozole in neoMONARCH, Phase II Neoadjuvant Study in HR+/HER2- Breast Cancer. Clin Cancer Res. 2020 Feb 1;26(3):566-580. doi: 10.1158/1078-0432.CCR-19-1425. Epub 2019 Oct 15. PMID 31615937