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| Therapy Name | Anastrozole + Palbociclib |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Anastrozole | Arimidex | Anastrozol | Aromatase Inhibitor 3 | Arimidex (anastrozole) is an aromatase inhibitor, which inhibits estrogen synthesis (PMID: 29719441). Arimidex (anastrozole) is FDA approved for postmenopausal women with hormone receptor-positive early breast cancer or advanced patients who have failed tamoxifen therapy (FDA.gov). |
| Palbociclib | Ibrance | PD0332991|PD-0332991 | CDK4/6 Inhibitor 14 | Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04711252 | Phase III | Anastrozole + Palbociclib Camizestrant + Palbociclib | A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease (SERENA-4) | Active, not recruiting | USA | TUR | SVK | POL | NOR | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BGR | BEL | AUT | 10 |
| NCT07174336 | Phase III | Letrozole + Palbociclib Fulvestrant + Palbociclib + STX-478 Anastrozole + Palbociclib Fulvestrant + Ribociclib + STX-478 Abemaciclib + Anastrozole + STX-478 Letrozole + Palbociclib + STX-478 Abemaciclib + Exemestane + STX-478 Letrozole + Ribociclib + STX-478 Abemaciclib + Fulvestrant + STX-478 Fulvestrant + Palbociclib Exemestane + Palbociclib Anastrozole + Palbociclib + STX-478 Abemaciclib + Letrozole + STX-478 Anastrozole + Ribociclib + STX-478 Exemestane + Palbociclib + STX-478 Exemestane + Ribociclib + STX-478 | A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) | Recruiting | USA | TUR | ITA | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 3 |
| NCT04075604 | Phase II | Anastrozole + Palbociclib Anastrozole + Nivolumab + Palbociclib | A Study of Neoadjuvant Nivolumab + Abemaciclib or Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (CheckMate 7A8) | Completed | USA | FRA | ESP | DEU | CAN | BEL | AUS | 1 |
| NCT05826964 | Phase II | Everolimus + Fulvestrant Exemestane + Ribociclib Everolimus + Tamoxifen Fulvestrant + Ribociclib Everolimus + Exemestane Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Alpelisib + Letrozole Abemaciclib + Exemestane Fulvestrant + Palbociclib Alpelisib + Fulvestrant Letrozole + Palbociclib Exemestane + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Fulvestrant | Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer | Recruiting | USA | 0 |
| NCT03820830 | Phase III | Anastrozole Exemestane Anastrozole + Palbociclib Letrozole Letrozole + Palbociclib Exemestane + Palbociclib | Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (POLAR) | Active, not recruiting | ITA | HUN | FRA | ESP | CHE | AUT | 0 |
| NCT04964934 | Phase III | Abemaciclib + Camizestrant Letrozole + Palbociclib Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Camizestrant + Palbociclib | Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (SERENA-6) | Active, not recruiting | USA | TUR | SVK | POL | NOR | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CHE | CAN | BGR | BEL | AUT | AUS | 5 |
| NCT04436744 | Phase II | Giredestrant + Palbociclib Anastrozole + Palbociclib | A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer | Completed | USA | POL | HUN | ESP | DEU | BRA | AUS | 4 |
| NCT03691493 | Phase II | Letrozole + Palbociclib Palbociclib + Tamoxifen Fulvestrant + Palbociclib Anastrozole + Palbociclib Exemestane + Palbociclib | Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis (ASPIRE) | Completed | USA | 0 |
| NCT06377852 | Phase III | Letrozole + Ribociclib Exemestane + Palbociclib Fulvestrant + Ribociclib Anastrozole + Palbociclib Anastrozole + Ribociclib Exemestane + Ribociclib Letrozole + Palbociclib Fulvestrant + Palbociclib | The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study | Recruiting | USA | 0 |
| NCT04256941 | Phase II | Abemaciclib + Fulvestrant Fulvestrant + Palbociclib Letrozole + Palbociclib Fulvestrant + Ribociclib Abemaciclib + Letrozole Anastrozole + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Anastrozole | 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 | USA | 0 |
| NCT02942355 | Phase II | Anastrozole + Palbociclib | Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer | Active, not recruiting | USA | 0 |
| NCT06486883 | Phase II | Abemaciclib + Fulvestrant Fulvestrant + Palbociclib Exemestane + Ribociclib Anastrozole + Ribociclib Exemestane + Palbociclib Letrozole + Ribociclib Abemaciclib + Exemestane Letrozole + Palbociclib Fulvestrant + Ribociclib Trastuzumab deruxtecan Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole | Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype (PONTIAC) | Recruiting | ITA | ESP | 1 |