Floatz Rating
B61/100
Confidence
Indicative
Sponsor
Fudan University
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
63High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07410559CT.gov Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT07191717CT.gov Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial | — | Not Yet Recruiting | — | — | — |
NCT07428018CT.gov Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib | — | Not Yet Recruiting | — | — | — |
NCT07340541CT.gov Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies | — | Recruiting | — | — | — |
NCT07292207CT.gov Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT06585969CT.gov A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer | — | Withdrawn | — | — | — |
NCT07112053CT.gov A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer | — | Recruiting | — | — | — |
NCT07225790CT.gov Emulation of the MONARCH-3 Trial Using Specialty Oncology Electronic Health Records Databases | — | Completed | — | — | — |
NCT07100106CT.gov A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer | — | Recruiting | — | — | — |
NCT06630325CT.gov A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer | — | Terminated | — | — | — |
Show 91 more trialsShow fewer
NCT07002177CT.gov A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC | — | Recruiting | — | — | — |
NCT06810492CT.gov The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment | — | Not Yet Recruiting | — | — | — |
NCT07190443CT.gov Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA) | — | Recruiting | — | — | — |
NCT06259929CT.gov NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer | — | Recruiting | — | — | — |
NCT06760637CT.gov Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease | — | Active Not Recruiting | — | — | — |
NCT06678269CT.gov A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT05933395CT.gov Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor | — | Recruiting | — | — | — |
NCT07487129CT.gov Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt | — | Completed | — | — | — |
NCT06139107CT.gov RADIANT: Pre-op Radiation With Abemaciclib and Letrozole | — | Recruiting | — | — | — |
NCT06561022CT.gov Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping | — | Not Yet Recruiting | — | — | — |
NCT06409390CT.gov Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer | — | Recruiting | — | — | — |
NCT06380751CT.gov Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT06179303CT.gov Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer | — | Recruiting | — | — | — |
NCT06495164CT.gov A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT06341283CT.gov A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer | — | Unknown | — | — | — |
NCT05708235CT.gov A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population | — | Recruiting | — | — | — |
NCT06207734CT.gov Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer | — | Recruiting | — | — | — |
NCT06169371CT.gov Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI) | — | Recruiting | — | — | — |
NCT05696626CT.gov Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | — | Recruiting | — | — | — |
NCT06001762CT.gov TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT05952557CT.gov An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) | — | Recruiting | — | — | — |
NCT06062498CT.gov Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT05867251CT.gov Study of AVZO-021 in Patients With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05372640CT.gov Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors | — | Recruiting | — | — | — |
NCT05826964CT.gov Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT05891093CT.gov Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01) | — | Recruiting | — | — | — |
NCT05774886CT.gov Implantable Microdevice for TNBC - Pilot Study | — | Withdrawn | — | — | — |
NCT06805812CT.gov Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study | — | Recruiting | — | — | — |
NCT05768139CT.gov First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05759949CT.gov First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors | — | Completed | — | — | — |
NCT05735080CT.gov Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer | — | Recruiting | — | — | — |
NCT05608252CT.gov VS-6766+Abema+Fulv in Met HR+/HER- BC | — | Recruiting | — | — | — |
NCT05548127CT.gov TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) | — | Active Not Recruiting | — | — | — |
NCT05563220CT.gov Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT05573126CT.gov Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer | — | Recruiting | — | — | — |
NCT05766410CT.gov A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC | — | Recruiting | — | — | — |
NCT05524584CT.gov Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT05464173CT.gov Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Breast Cancer Patients Previously Treated With Palbociclib | — | Unknown | — | — | — |
NCT05307705CT.gov A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT04791384CT.gov Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer | — | Terminated | — | — | — |
NCT05065411CT.gov Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer | — | Terminated | — | — | — |
NCT05189717CT.gov A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults | — | Unknown | — | — | — |
NCT06570031CT.gov ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer | — | Completed | — | — | — |
NCT04523857CT.gov ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer | — | Recruiting | — | — | — |
NCT04316169CT.gov Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer | — | Withdrawn | — | — | — |
NCT05095207CT.gov Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT04481113CT.gov Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer | — | Completed | — | — | — |
NCT04603183CT.gov ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL | — | Completed | — | — | — |
NCT04862663CT.gov Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) | — | Recruiting | — | — | — |
NCT04614194CT.gov Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib | — | Recruiting | — | — | — |
NCT04852081CT.gov Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study. | — | Unknown | — | — | — |
NCT04584853CT.gov PreOperative Endocrine Therapy for Individualised Care With Abemaciclib | — | Active Not Recruiting | — | — | — |
NCT04681768CT.gov Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients | — | Completed | — | — | — |
NCT04514159CT.gov A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer | — | Completed | — | — | — |
NCT04351230CT.gov T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer | — | Withdrawn | — | — | — |
NCT04293393CT.gov Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients | — | Active Not Recruiting | — | — | — |
NCT04432454CT.gov Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | — | Completed | — | — | — |
NCT04352777CT.gov Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer | — | Completed | — | — | — |
NCT04565054CT.gov Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC | — | Active Not Recruiting | — | — | — |
NCT03846583CT.gov Tucatinib + Abemaciclib + Herceptin for HER2+ MBC | — | Withdrawn | — | — | — |
NCT03939897CT.gov Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT04585724CT.gov Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases | — | Withdrawn | — | — | — |
NCT05153135CT.gov Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors | — | Completed | — | — | — |
NCT05141240CT.gov A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors | — | Completed | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT04305834CT.gov Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer. | — | Recruiting | — | — | — |
NCT03979508CT.gov Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer | — | Terminated | — | — | — |
NCT04227327CT.gov Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7) | — | Terminated | — | — | — |
NCT04188548CT.gov A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer | — | Active Not Recruiting | — | — | — |
NCT04088032CT.gov Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer | — | Withdrawn | — | — | — |
NCT03988114CT.gov A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer | — | Withdrawn | — | — | — |
NCT04031885CT.gov A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer | — | Terminated | — | — | — |
NCT04256941CT.gov Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study | — | Terminated | — | — | — |
NCT03703466CT.gov A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer | — | Completed | — | — | — |
NCT03424005CT.gov A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT03284957CT.gov Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer | — | Terminated | — | — | — |
NCT03155997CT.gov Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03130439CT.gov Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer | — | Terminated | — | — | — |
NCT02763566CT.gov A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02779751CT.gov A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02784795CT.gov A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors | — | Terminated | — | — | — |
NCT02747004CT.gov A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02831530CT.gov Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients | — | Completed | — | — | — |
NCT02441946CT.gov A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer | — | Completed | — | — | — |
NCT02308020CT.gov A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain | — | Completed | — | — | — |
NCT02246621CT.gov A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02102490CT.gov A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread | — | Completed | — | — | — |
NCT01655225CT.gov A Study of LY3023414 in Participants With Advanced Cancer | — | Completed | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | Recruiting | — | — | — |
NCT02792725CT.gov Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer | — | Approved For Marketing | — | — | — |
NCT03763604CT.gov Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer | — | Approved For Marketing | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Abemaciclib (this asset) | Fudan University | Approved | B · 61 |
| Darolutamide | Vandana Abramson | P2 | BBB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Palbociclib | Hoffmann-La Roche | P4 | BB |
| Trastuzumab Duocarmazine | Byondis B.V. | P3 | BB |
| Goserelin | TerSera Therapeutics LLC | P4 | BB |
| Ribociclib | National Cancer Institute (NCI) | P4 | BB |
| Oxaliplatin | Beijing Biostar Pharmaceuticals Co., Ltd. | P4 | BB |
| Eribulin Monomethanesulfonate | Henan Cancer Hospital | P4 | BB |
+42 more in the Breast Cancer cohort
Other indications for Abemaciclib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Hormone Receptor-Positive Breast Cancer | — | P4 | BBB · 72 |
| Estrogen-Receptor Positive Breast Cancer | — | P3 | BB · 70 |
| Metastatic Neoplasm | — | P4 | BB · 67 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Abemaciclib in Breast Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/abemaciclib-breast-cancer
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