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 |
|---|---|---|---|---|---|---|
| NCT04130152 | Phase I | Letrozole + Palbociclib | Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy | Completed | ESP | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT04220476 | Phase II | Letrozole + Palbociclib | CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer (CIMER) | Withdrawn | 0 | |
| NCT03007979 | Phase II | Goserelin Fulvestrant + Palbociclib Letrozole + Palbociclib | Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer | Completed | USA | 0 |
| 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 |
| 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 |
| NCT04563507 | Phase II | Letrozole + Palbociclib | Combined Immunotherapies in Metastatic ER+ Breast Cancer | 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 | Completed | 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 |
| 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 |
| 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 |
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