Therapy Detail

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Therapy Name Letrozole + Palbociclib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Letrozole Femara Letrozol Aromatase Inhibitor 3 Femara (letrozole) is an aromatase inhibitor, which inhibits estrogen synthesis, and is approved for postmenopausal women with hormone receptor positive breast cancer (FDA.gov).
Palbociclib Ibrance PD0332991|PD-0332991 CDK4/6 Inhibitor 13 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
NCT03355157 FDA approved Exemestane + Palbociclib Tamoxifen Paclitaxel Exemestane Capecitabine Palbociclib + Tamoxifen Epirubicin Vinorelbine Fulvestrant + Palbociclib Fulvestrant Letrozole Letrozole + Palbociclib A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study). (PADMA) Unknown status DEU 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
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) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13
NCT04130152 Phase I Letrozole + Palbociclib Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy Completed ESP 0
NCT04546009 Phase III Letrozole + Palbociclib Giredestrant + Palbociclib A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) Active, not recruiting USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 19
NCT05226871 Phase II Letrozole + Palbociclib Cetuximab + Palbociclib Cetuximab Fulvestrant + Palbociclib Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies Recruiting USA 3
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
NCT05909397 Phase III Letrozole + Palbociclib Palbociclib + Vepdegestrant A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer (VERITAC-3) Recruiting USA | ITA | ESP | AUS 6
NCT03809988 Phase II Fulvestrant Fulvestrant + Palbociclib Letrozole Letrozole + Palbociclib PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) Completed ITA | GBR | FRA | ESP | DEU 1
NCT03007979 Phase II Goserelin Fulvestrant + Palbociclib Letrozole + Palbociclib Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer Completed USA 0
NCT04563507 Phase II Letrozole + Palbociclib Combined Immunotherapies in Metastatic ER+ Breast Cancer Recruiting USA 0
NCT02142868 Phase III Letrozole + Palbociclib Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate No longer available USA | CAN 0
NCT02692755 Phase II Fulvestrant + Palbociclib Letrozole + Palbociclib Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (PALINA) 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
NCT05207709 Phase III Letrozole + Ribociclib Fulvestrant + Palbociclib Letrozole + Palbociclib Fulvestrant + Ribociclib Paclitaxel Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype (HARMONIA) Recruiting USA | ESP 1
NCT04220476 Phase II Letrozole + Palbociclib CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer (CIMER) Withdrawn 0
NCT04478266 Phase III Letrozole + Palbociclib Amcenestrant + Goserelin + Palbociclib Goserelin + Letrozole + Palbociclib Amcenestrant + Palbociclib SAR439859 Plus Palbociclib as First Line Therapy for Patients With ER(+) HER2(-) Advanced Breast Cancer (AMEERA-5) Terminated USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 19
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 | FRA | ESP | AUT 2


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