Floatz Rating
BB69/100
Confidence
Indicative
Sponsor
Eli Lilly and Company
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.
71High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07174336CT.gov A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) | — | Recruiting | — | — | — |
NCT07096024CT.gov A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market | — | Completed | — | — | — |
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 | — | — | — |
NCT04916509CT.gov Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region | — | Completed | — | — | — |
NCT05584644CT.gov A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer | — | Completed | — | — | — |
NCT04858997CT.gov Tumor Response Time of Palbociclib in Combination With AI in Real-world Chinese Patients | — | Unknown | — | — | — |
NCT04767594CT.gov First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting. | — | Active Not Recruiting | — | — | — |
NCT04288089CT.gov A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03900884CT.gov Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03756090CT.gov The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer | — | Unknown | — | — | — |
Show 14 more trialsShow fewer
NCT03455270CT.gov G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer | — | Completed | — | — | — |
NCT03423199CT.gov PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY | — | Unknown | — | — | — |
NCT03447132CT.gov Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant | — | Completed | — | — | — |
NCT03304080CT.gov Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast | — | Active Not Recruiting | — | — | — |
NCT03284723CT.gov PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors | — | Terminated | — | — | — |
NCT03220178CT.gov Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy | — | Terminated | — | — | — |
NCT02690480CT.gov Fulvestrant (F)+Placebo vs F+Palbociclib First Line for Postmenopausal Hormone Receptor+ Advanced Breast Cancer | — | Unknown | — | — | — |
NCT02530424CT.gov "Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment " | — | Completed | — | — | — |
NCT02297438CT.gov A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4] | — | Completed | — | — | — |
NCT02296801CT.gov A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer | — | Completed | — | — | — |
NCT01864746CT.gov A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery | — | Completed | — | — | — |
NCT01723774CT.gov PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT01740427CT.gov A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) | — | Completed | — | — | — |
NCT01684215CT.gov A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Neoplasm
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Palbociclib (this asset) | Eli Lilly and Company | Approved | BB · 69 |
| Tamoxifen | Eli Lilly and Company | P3 | BB |
| Cyclophosphamide | Merck Sharp & Dohme LLC | P4 | BB |
| Exemestane | Fujian Cancer Hospital | P4 | BB |
| Docetaxel | Universitas Airlangga | P4 | BB |
| Letrozole | Fujian Cancer Hospital | P4 | BB |
| Adriamycin | Merck Sharp & Dohme LLC | P4 | BB |
| Microporous Polysaccharide Hemospheres | Fundación para la Investigación del Hospital Clínico de Valencia | P4 | BB |
| Epirubicin | Universitas Airlangga | P4 | BB |
+42 more in the Breast Neoplasm cohort
Other indications for Palbociclib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Her2-Receptor Negative Breast Cancer | — | P2 | BBB · 75 |
| Hormone Receptor-Positive Breast Cancer | — | P3 | BBB · 73 |
| Breast Cancer | — | P4 | BB · 71 |
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. Palbociclib in Breast Neoplasm. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 13, 2026. https://terminal.floatz.ai/assets/palbociclib-breast-neoplasm
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