NCT03439046 - Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant | Biotech Hunter

Enrollment

287

Participants

Timeline

Start Date

February 2, 2018

Primary Completion Date

December 11, 2023

Study Completion Date

December 11, 2023

Conditions

Breast Cancer

Interventions

DRUG

Ribociclib

Ribociclib oral (3weeks on/1week off) in combination with oral once daily letrozole: 600mg tablets ribociclib QD + 2.5 mg tablets letrozole QD

DRUG

Letrozole

Ribociclib oral (3weeks on/1week off) in combination with oral once daily letrozole: 600mg tablets ribociclib QD + 2.5 mg tablets letrozole QD

DRUG

Alpelisib

Alpelisib 300 mg oral daily on a continuous dosing schedule in combination with fulvestrant 500 mg intramuscular on Days 1 and 15 of Cycle 1, and on Day 1 of each cycle thereafter in a 28 days cycle

DRUG

Fulvestrant

Alpelisib 300 mg oral daily on a continuous dosing schedule in combination with fulvestrant 500 mg intramuscular on Days 1 and 15 of Cycle 1, and on Day 1 of each cycle thereafter in a 28 days cycle

Trial Locations (41)

10060

Novartis Investigative Site, Candiolo

10128

Novartis Investigative Site, Torino

15033

Novartis Investigative Site, Casale Monferrato

16132

Novartis Investigative Site, Genova

20089

Novartis Investigative Site, Rozzano

20132

Novartis Investigative Site, Milan

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20900

Novartis Investigative Site, Monza

24127

Novartis Investigative Site, Bergamo

25123

Novartis Investigative Site, Brescia

26100

Novartis Investigative Site, Cremona

33081

Novartis Investigative Site, Aviano

33100

Novartis Investigative Site, Udine

35100

Novartis Investigative Site, Padua

37024

Novartis Investigative Site, Negrar

40138

Novartis Investigative Site, Bologna

44100

Novartis Investigative Site, Cona

48018

Novartis Investigative Site, Faenza

56126

Novartis Investigative Site, Pisa

57124

Novartis Investigative Site, Livorno

59100

Novartis Investigative Site, Prato

61032

Novartis Investigative Site, Fano

62100

Novartis Investigative Site, Macerata

70124

Novartis Investigative Site, Bari

71013

Novartis Investigative Site, San Giovanni Rotondo

72100

Novartis Investigative Site, Brindisi

80131

Novartis Investigative Site, Napoli

80138

Novartis Investigative Site, Napoli

82100

Novartis Investigative Site, Benevento

84131

Novartis Investigative Site, Salerno

90127

Novartis Investigative Site, Palermo

90146

Novartis Investigative Site, Palermo

95123

Novartis Investigative Site, Catania

95124

Novartis Investigative Site, Catania

98158

Novartis Investigative Site, Messina

08100

Novartis Investigative Site, Nuoro

06129

Novartis Investigative Site, Perugia

00128

Novartis Investigative Site, Roma

00168

Novartis Investigative Site, Roma

00189

Novartis Investigative Site, Roma