AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT00868816
Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles
Trial: NCT00868816
Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy
RxNorm normalized name: Oxaliplatin
DrugBank: Oxaliplatin (DB00526)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles
Trial: NCT02767297
Drug: FDL169
RxNorm normalized name: FDL169
DrugBank: FDL169 (DB16878)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00566202
Drug: Escitalopram
RxNorm normalized name: Escitalopram
DrugBank: Escitalopram (DB01175)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 20 mg daily for 6 weeks, and 10 mg daily for 1 week.
Trial: NCT00566202
Drug: JNJ-18038683
RxNorm normalized name: JNJ-42847922
DrugBank: Seltorexant (DB14961)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.
Trial: NCT01239732
Drug: Paclitaxel
RxNorm normalized name: Paclitaxel
DrugBank: Paclitaxel (DB01229)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 175 mg/m\^2 on Day 1 every 3 weeks or at a dose of 80 mg/m\^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
Trial: NCT01239732
Drug: Bevacizumab
RxNorm normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first
Trial: NCT01239732
Drug: Carboplatin
RxNorm normalized name: Carboplatin
DrugBank: Carboplatin (DB00958)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
Trial: NCT01779791
Drug: PCI-32765 (Ibrutinib)
RxNorm normalized name: Ibrutinib
DrugBank: Ibrutinib (DB09053)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 560 mg capsules administered orally once daily, continuously on a 21-day cycle until progressive disease.
Trial: NCT02917057
Drug: exenatide once weekly
RxNorm normalized name: Exenatide
DrugBank: Exenatide (DB01276)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Exenatide treatment in customary clinical care in the USA
Trial: NCT02917057
Drug: basal insulin
RxNorm normalized name: INSULIN
DrugBank: Insulin human (DB00030)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: basal insulin tretament in the customary clinical care in USA
Trial: NCT01948856
Drug: J022X ST
RxNorm normalized name: STS
DrugBank: Sodium tetradecyl sulfate (DB00464)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach~* First month: 4 consecutive days per week during 3 consecutive weeks~* 5 next months: 4 consecutive days per month at monthly intervals
Trial: NCT04458324
Drug: Buspirone Hydrochloride
RxNorm normalized name: Buspirone Hydrochloride
DrugBank: Buspirone (DB00490)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Subjects take 30 mg buspirone HCl twice a day for 6 months.
Trial: NCT04526821
Drug: Bovine Lactoferrin
RxNorm normalized name: Bovine lactoferrin
DrugBank: Lactoferrin (DB16555)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Bovine Lactoferrin 600mg daily for 12 weeks (3 chewable tablets of 100mg , twice a day), for 12 weeks plus personal portection provided from the hospital.
Trial: NCT00798278
Drug: Urokinase
RxNorm normalized name: Urokinase
DrugBank: Urokinase (DB00013)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Chest tube with intrapleural urokinase infusion for 3 days
Trial: NCT03265223
Drug: 0.2% ropivacaine
DrugBank: Ropivacaine (DB00296)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intraperitoneal instillation versus intraincisional infiltration
Trial: NCT03062254
Drug: radium-223 dichloride
RxNorm normalized name: radium-223 dichloride
DrugBank: Radium Ra 223 dichloride (DB08913)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 6 doses of Radium-223
Trial: NCT03618589
Drug: Pregabalin
RxNorm normalized name: Pregabalin
DrugBank: Pregabalin (DB00230)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.
Trial: NCT01265875
Drug: Human Secretin
RxNorm normalized name: Human secretin
DrugBank: Secretin human (DB09532)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Dose Escalation
Trial: NCT01397734
Drug: Arsenic trioxide
RxNorm normalized name: Arsenic Trioxide
DrugBank: Arsenic trioxide (DB01169)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: 0.15mg/kg/day Arsenic trioxide given IV on days 1-5 of the cycle.
Trial: NCT00333944
Drug: Pralidoxime(drug)
DrugBank: Pralidoxime (DB00733)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03381261
Drug: Botulinum toxin type A
RxNorm normalized name: Botulinum toxin type A
DrugBank: Botulinum toxin type A (DB00083)
FDA approved: no
EMA approved: yes
PMDA approved: yes
Description: Injection of Botulinum toxin type A in back of head
Trial: NCT02564952
Drug: Clobazam
RxNorm normalized name: Clobazam
DrugBank: Clobazam (DB00349)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants were taking CLB upon entry into the OLE phase of the trial. CLB was not an investigational medicinal product (IMP) for the OLE phase and was not administered by the Sponsor, but was administered at the physician's discretion, as required for each participant. CLB could be stopped, if clinically indicated, without impact on analysis.
Trial: NCT02937285
Drug: Interferon beta 1a
RxNorm normalized name: Interferon beta 1a
DrugBank: Interferon beta-1a (DB00060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Subcutaneous injection of 44µg 3 times a week
Trial: NCT02937285
Drug: Mitoxantrone
RxNorm normalized name: Mitoxantrone
DrugBank: Mitoxantrone (DB01204)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 10 mg / m² monthly infusion for 6 months
Trial: NCT00993629
Drug: pregnenolone
RxNorm normalized name: Pregnenolone
DrugBank: Pregnenolone (DB02789)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Administered adjunctively to treatment as usual
Trial: NCT02379650
Drug: Hydroxychloroquine (HCQ)
DrugBank: Hydroxychloroquine (DB01611)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT00350818
Drug: Azacitidine
RxNorm normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 8 mg/m\^2 Subcutaneously Once Daily for 5 Days
Trial: NCT04007406
Drug: dexfadrostat phosphate
RxNorm normalized name: dextroamphetamine sulfate Oral Tablet [DextroStat]
DrugBank: Amphetamine (DB00182)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: DP13 systemic administration
Trial: NCT00638118
Drug: Fexofenadine
RxNorm normalized name: Fexofenadine
DrugBank: Fexofenadine (DB00950)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01685333
Drug: Epoetin Alfa
RxNorm normalized name: epoetin alfa
DrugBank: Erythropoietin (DB00016)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Intravenous single-dose administration of 100 IU/kg of the test drug (Human Recombinant Epoetin) in the first period and intravenous single-dose administration of 100 IU/kg of the comparator drug (Eprex) in the second period, after 23-30 days of washout, or vice-versa.
Trial: NCT03511898
Drug: THR-149 dose level 1
RxNorm normalized name: Thr
DrugBank: Threonine (DB00156)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: single intravitreal injection of THR-149 dose level 1
Trial: NCT03511898
Drug: THR-149 dose level 2
RxNorm normalized name: Thr
DrugBank: Threonine (DB00156)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: single intravitreal injection of THR-149 dose level 2
Trial: NCT03511898
Drug: THR-149 dose level 3
RxNorm normalized name: Thr
DrugBank: Threonine (DB00156)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: single intravitreal injection of THR-149 dose level 3
Trial: NCT00428584
Drug: New Formulation of rebif - human interferon beta-1a
RxNorm normalized name: interferon beta-1a Prefilled Syringe [Rebif]
DrugBank: Interferon beta-1a (DB00060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.
Trial: NCT00428584
Drug: Interferon beta -1b
RxNorm normalized name: Interferon Beta-1B
DrugBank: Interferon beta-1b (DB00068)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.
Trial: NCT00183729
Drug: Memantine
RxNorm normalized name: Memantine
DrugBank: Memantine (DB01043)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
Trial: NCT03199755
Drug: ACT
RxNorm normalized name: ACTH
DrugBank: Famotidine (DB00927)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Current approved drug for treating malaria
Trial: NCT03199755
Drug: DLA1
RxNorm normalized name: Dapagliflozin
DrugBank: Dapagliflozin (DB06292)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Experimental drug treatment, single dose.
Trial: NCT03199755
Drug: DLA2
RxNorm normalized name: Dapagliflozin
DrugBank: Dapagliflozin (DB06292)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Experimental drug treatment, doubled the dose of DLA1.
Trial: NCT04024527
Drug: Esomeprazole
RxNorm normalized name: Esomeprazole
DrugBank: Esomeprazole (DB00736)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Proton pump inhibitor
Trial: NCT04024527
Drug: Amoxicillin
RxNorm normalized name: Amoxicillin
DrugBank: Amoxicillin (DB01060)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Antibiotic for H. pylori eradication
Trial: NCT04024527
Drug: Metronidazole
RxNorm normalized name: Metronidazole
DrugBank: Metronidazole (DB00916)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Antibiotic for H. pylori eradication
Trial: NCT00043550
Drug: Sertraline
RxNorm normalized name: Sertraline
DrugBank: Sertraline (DB01104)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive sertraline.
Trial: NCT00043550
Drug: Venlafaxine
RxNorm normalized name: Venlafaxine
DrugBank: Venlafaxine (DB00285)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Participants will receive venlafaxine.
Trial: NCT03125239
Drug: Merestinib
RxNorm normalized name: Merestinib
DrugBank: Merestinib (DB12381)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oral, once a day, Merestinib Only- Lead in period on week. The followed by cycles on combination therapy with Merestinib and LY2874455 (28 days long)
Trial: NCT04762316
Drug: SB-UF
RxNorm normalized name: SB-649868
DrugBank: SB-649868 (DB14822)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dosage:~-Take 1tablet/2 times/day/in throughout pregnancy.
Trial: NCT00117013
Drug: Fluorine-19-Fluoroded Xyglucose
RxNorm normalized name: fluorine
DrugBank: Fluorine F-18 (DB13134)
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00117013
Drug: Topotecan
RxNorm normalized name: Topotecan
DrugBank: Topotecan (DB01030)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02801201
Drug: Midazolam
RxNorm normalized name: Midazolam
DrugBank: Midazolam (DB00683)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT02801201
Drug: Bupivacaine
RxNorm normalized name: Bupivacaine
DrugBank: Bupivacaine (DB00297)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03054168
Drug: Zoladex
RxNorm normalized name: Zoladex
DrugBank: Goserelin (DB00014)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: The frequency of the injection will be just one injection, 3.6 mg of Zoladex, Subcutaneous injection (abdomen).
Trial: NCT01917656
Drug: liraglutide
RxNorm normalized name: Liraglutide
DrugBank: Liraglutide (DB06655)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: 1.8 mg administered subcutaneously (s.c., under the skin) once daily
Trial: NCT01917656
Drug: metformin
RxNorm normalized name: Metformin
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
Trial: NCT02444000
Drug: PCV chemotherapy alone
RxNorm normalized name: PCV
DrugBank: Penciclovir (DB00299)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: PCV cycles are 6 weeks long~PCV chemotherapy is given as:~Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally
Trial: NCT02444000
Drug: Radiotherapy+PCV chemotherapy
RxNorm normalized name: PCV
DrugBank: Penciclovir (DB00299)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Radiotherapy followed by 6 cycles of PCV
Trial: NCT03579602
Drug: tozuleristide
RxNorm normalized name: Tozuleristide
DrugBank: Tozuleristide (DB15375)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor.
Trial: NCT02970682
Drug: Fulvestrant
RxNorm normalized name: Fulvestrant
DrugBank: Fulvestrant (DB00947)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Fulvestrant
Trial: NCT02970682
Drug: Tamoxifen
RxNorm normalized name: Tamoxifen
DrugBank: Tamoxifen (DB00675)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Tamoxifen
Trial: NCT02687867
Drug: Dabigatran (Pradaxa)
RxNorm normalized name: dabigatran etexilate Oral Pellet [Pradaxa]
DrugBank: Dabigatran (DB14726)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: As prescribed by treating physicians
Trial: NCT02303418
Drug: Carbetocin
RxNorm normalized name: Carbetocin
DrugBank: Carbetocin (DB01282)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Carbetocin will be given slowly iv after delivery of the baby
Trial: NCT02303418
Drug: Oxytocin
RxNorm normalized name: Oxytocin
DrugBank: Oxytocin (DB00107)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Oxytocin will be given slowly iv after delivery of the baby
Trial: NCT00167856
Drug: Venalafaxine hydrochloride
RxNorm normalized name: Venlafaxine Hydrochloride
DrugBank: Venlafaxine (DB00285)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
Trial: NCT02834845
Drug: Sevoflurane
RxNorm normalized name: Sevoflurane
DrugBank: Sevoflurane (DB01236)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Sevoflurane %2-3 for general anesthesia maintenance
Trial: NCT02834845
Drug: Desflurane
RxNorm normalized name: Desflurane
DrugBank: Desflurane (DB01189)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Desflurane %6-8 for general anesthesia maintenance
Trial: NCT02807415
Drug: Lumacaftor plus Ivacaftor
RxNorm normalized name: ivacaftor / lumacaftor
DrugBank: Ivacaftor (DB08820)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Oral treatment with lumacaftor/ivacaftor tablets according to the prescribing information
Trial: NCT02251431
Drug: BYDUREON
RxNorm normalized name: Bydureon
DrugBank: Exenatide (DB01276)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Exenatide-extended release, Cohorts A and B
Trial: NCT01042379
Drug: AMG 386 with or without Trastuzumab
RxNorm normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: AMG 479 (Ganitumab) plus Metformin
RxNorm normalized name: Ganitumab
DrugBank: Metformin (DB00331)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Arm is closed.
Trial: NCT01042379
Drug: MK-2206 with or without Trastuzumab
RxNorm normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: AMG 386 and Trastuzumab
RxNorm normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: T-DM1 and Pertuzumab
RxNorm normalized name: T-DM1
DrugBank: Pertuzumab (DB06366)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: Pertuzumab and Trastuzumab
RxNorm normalized name: pertuzumab and trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization; Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization
Trial: NCT01042379
Drug: Ganetespib
RxNorm normalized name: Ganetespib
DrugBank: Ganetespib (DB12047)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm is closed.
Trial: NCT01042379
Drug: ABT-888
RxNorm normalized name: ABT-925
DrugBank: ABT-288 (DB15192)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm is closed.
Trial: NCT01042379
Drug: Neratinib
RxNorm normalized name: NERATINIB
DrugBank: Neratinib (DB11828)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Arm is closed.
Trial: NCT01042379
Drug: Pembrolizumab - 4 cycle
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: Talazoparib plus Irinotecan
DrugBank: Irinotecan (DB00762)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: Patritumab and Trastuzumab
RxNorm normalized name: pertuzumab and trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: Pembrolizumab - 8 cycle
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: SGN-LIV1A
RxNorm normalized name: SGN-LIV1A
DrugBank: Ladiratuzumab vedotin (DB15409)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Arm is closed. SGN-LIV1A: 2.5 mg/kg IV cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16
Trial: NCT01042379
Drug: Durvalumab plus Olaparib
DrugBank: Olaparib (DB09074)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed.
Trial: NCT01042379
Drug: SD-101 + Pembrolizumab
DrugBank: Pembrolizumab (DB09037)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed. SD-101: IT injection 2 mg/ml (1 ml for T2 tumors, 2 ml for \>T3 tumors) weekly x 4, then every 3 weeks x 2 cycles 1,2,3,4,7,10 Pembrolizumab: 200mg IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Trial: NCT01042379
Drug: Tucatinib plus trastuzumab and pertuzumab
RxNorm normalized name: hyaluronidase / pertuzumab / trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Arm is closed. Tucatinib: 300 mg PO BID 12 weeks CLOSED Tucatinib: 250 mg PO BID 12 weeks CLOSED Tucatinib adaptive: 150mg BID days 1-28, 250mg BID days 29-84 Trastuzumab: 4 mg/kg IV (loading dose) cycle 1; 2 mg/kg (thereafter) cycles 2-12 Pertuzumab: 840 mg IV (loading dose) cycle 1; 420 mg (thereafter) cycles 4, 7 and 10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Trial: NCT01042379
Drug: Cemiplimab
RxNorm normalized name: CEMIPLIMAB
DrugBank: Cemiplimab (DB14707)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Trial: NCT01042379
Drug: Cemiplimab plus REGN3767
RxNorm normalized name: CEMIPLIMAB
DrugBank: Cemiplimab (DB14707)
FDA approved: yes
EMA approved: yes
PMDA approved: no
Description: Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 REGN 3767: 1600 mg q3W X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Trial: NCT01042379
Drug: Trilaciclib with or without trastuzumab + pertuzumab
RxNorm normalized name: hyaluronidase / pertuzumab / trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: Trilaciclib: 240 mg/m2 IV weekly cycle 1-16 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles~For HER2+:~Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization
Trial: NCT01042379
Drug: SYD985 ([vic-]trastuzumab duocarmazine)
RxNorm normalized name: trastuzumab
DrugBank: Trastuzumab (DB00072)
FDA approved: yes
EMA approved: yes
PMDA approved: yes
Description: SYD985: 1.2 mg/kg IV (q3w x 12 weeks) cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles