Floatz Rating
BB70/100
Confidence
Indicative
Sponsor
Hongmei Zheng, PhD
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 |
|---|---|---|---|---|---|
NCT06810492CT.gov The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment | — | Not Yet Recruiting | — | — | — |
NCT06856200CT.gov A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT05949424CT.gov OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults | — | Unknown | — | — | — |
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 | — | — | — |
NCT05238831CT.gov SMMART Adaptive Clinical Treatment (ACT) Trial | — | Withdrawn | — | — | — |
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 | — | — | — |
NCT04498520CT.gov Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer | — | Withdrawn | — | — | — |
NCT04585724CT.gov Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases | — | Withdrawn | — | — | — |
NCT04224272CT.gov A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer | — | Completed | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
Show 19 more trialsShow fewer
NCT03609047CT.gov Adjuvant Palbociclib in Elderly Patients With Breast Cancer | — | Active Not Recruiting | — | — | — |
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 | — | — | — |
NCT03691493CT.gov Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis | — | Completed | — | — | — |
NCT03774472CT.gov Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer | — | Completed | — | — | — |
NCT03455270CT.gov G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer | — | Completed | — | — | — |
NCT03128619CT.gov Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer | — | Terminated | — | — | — |
NCT02907918CT.gov Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer | — | Terminated | — | — | — |
NCT03007979CT.gov Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer | — | Completed | — | — | — |
NCT02760030CT.gov Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery | — | Completed | — | — | — |
NCT02897375CT.gov Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors | — | Completed | — | — | — |
NCT02778685CT.gov Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02774681CT.gov Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis | — | Terminated | — | — | — |
NCT02592083CT.gov Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors | — | Active Not Recruiting | — | — | — |
NCT02465060CT.gov Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | — | Active Not Recruiting | — | — | — |
NCT02603679CT.gov Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases | — | Active Not Recruiting | — | — | — |
NCT02400567CT.gov Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women | — | 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 | — | — | — |
NCT02008734CT.gov Randomized Phase II Study to Assess PD 0332991 in Breast Cancer | — | Completed | — | — | — |
NCT01037790CT.gov Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Palbociclib (this asset) | Hongmei Zheng, PhD | Approved | BB · 70 |
| Trastuzumab | SWOG Cancer Research Network | P4 | BBB |
| Tamoxifen | Dartmouth-Hitchcock Medical Center | P4 | BBB |
| Zoledronate | Washington University School of Medicine | P4 | BBB |
| Pertuzumab | SWOG Cancer Research Network | P3 | BBB |
| Trastuzumab Deruxtecan | SWOG Cancer Research Network | P4 | BBB |
| Cyclophosphamide | UNC Lineberger Comprehensive Cancer Center | P3 | BBB |
| Letrozole | OHSU Knight Cancer Institute | P4 | BBB |
| Olaparib | The Netherlands Cancer Institute | P4 | BBB |
+42 more in the Breast Carcinoma 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 Carcinoma. 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/palbociclib-breast-carcinoma
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