Table 3 Drugs with patient-reported outcome measure findings in Food and Drug Administration medical review documents
From: Patient-reported outcomes in breast cancer FDA drug labels and review documents
Brand namea | PRO measureb | Classification (Symptom, function, or both) | Clinical trials that used PRO measures | Trial design | PRO endpoint status | Analytical methods of PRO datab |
|---|---|---|---|---|---|---|
Faslodex (Fulvestrant) | FACT-B TOI | Both | Trial #20 | Phase 3, Randomized, Open label, Active-controlled trial | Secondary | Time to deterioration in QoL |
Faslodex (Fulvestrant) | FACT-B TOI | Both | Trial #21 | Phase 3, Randomized, Double-blind, Active-controlled trial | Secondary | Time to deterioration in QoL, Change in TOI |
Tykerb (Lapatinib) | FACT-B, EQ-5D | Both | EGF 100151 | Phase 3, Randomized, Open label, Active-Controlled trial | Secondary | Change in QoL |
Tykerb (Lapatinib) | FACT-B | Both | EGF 20008 | Phase 2, Open label, Uncontrolled, Two-cohort trial | Secondary | Change in QoL |
Ixempra (Ixabepilone) | FBSI | Symptom | Study 046 | Phase 3, Randomized, Open label, Active-controlled trial | Secondary | Changes in symptoms during therapy |
Perjeta (Pertuzumab) | FACT-B TOI | Both | CLEOPATRA | Phase 3, Randomized, Double-blind, Placebo-controlled trial | Secondary | Time to symptom progression |
Kadcyla (Ado-trastuzumab emtansine) | FACT-B TOI | Both | EMILIA | Phase 3, Randomized, Open label, Active-controlled trial | Secondary | Time to symptom progression |
Ibrance (Palbociclib) | mBPI-sf | Symptom | PALOMA-1 | Phase 1/2, Randomized, Open label, Active-controlled trial | Secondary | Changes in symptoms during therapy (pain) |
Kisqali (Ribociclib) | EORTC QLQ-C30, EORTC QLQ-BR23, EQ-5D-5 L | Both | MONALEESA-2 | Phase 3, Randomized, Double-blind, Placebo-controlled trial | Secondary | Time to deterioration in QoL, Change in QoL |
Nerlynx (Neratinib) | EQ-5D, FACT-B | Both | Study 3004 | Phase 3, Randomized, Double-blind, Placebo-controlled trial | Exploratory | Change in QoL |
Verzenio (Abemaciclib) | mBPI-sf, EORTC QLQ-C30, EORTC QLQ-BR23, EQ-5D-5 L | Symptom (mBPI-sf), Both (rest) | MONARCH 2 | Phase 3, Randomized, Double-blind, Placebo-controlled trial | Secondary | Time to symptom progression, Change in QoL and symptom |
Verzenio (Abemaciclib) | mBPI-sf, EORTC QLQ-C30 | Symptom (mBPI-sf), Both (rest) | MONARCH 1 | Phase 2, Open label, Single arm trial | Secondary | Change in QoL and symptom |
Talzenna (Talazoparib) | EORTC QLQ-C30, EORTC QLQ-BR23 | Both | EMBRACA | Phase 3, Randomized, Open label, Active-controlled trial | Exploratory | Time to deterioration in QoL and symptom |
Piqray (Alpelisib) | BPI-sf, EORTC QLQ-C30, EQ-5D-5 L | Symptom (BPI-sf), Both (rest) | SOLAR-1 | Phase 3, Randomized, Double-blind, Placebo-controlled trial | Secondary | Time to deterioration in QoL, symptom, and functioning |