Therapy Detail

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Therapy Name Anastrozole + Palbociclib
Synonyms
Therapy Description

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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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Recruiting ITA | HUN | FRA | ESP | CHE | AUT 0
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
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 Completed USA 0
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
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
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
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
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
NCT02942355 Phase II Anastrozole + Palbociclib Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer Active, not recruiting 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


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