222
Participants
Start Date
February 25, 2019
Primary Completion Date
April 12, 2022
Study Completion Date
May 10, 2023
Docetaxel / Capecitabine
"Docetaxel (IV Infusion) / Capecitabine (Tablets for oral use):~Docetaxel once, on day 1 of the 3-weeks cycle. Capecitabine twice daily, on Days 1 to 14, followed by a 1-week rest period, in 3 weeks cycle.~Docetaxel (60 - 75 mg/m²)/capecitabine (1600 - 2500 mg/m²/day)"
Capecitabine / Vinorelbine
"Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion ).~Capecitabine twice daily on day 1 to 14, followed by a 1-week rest period, in 3 weeks cycle.~Vinorelbine, once, on Day 1 and Day 8 in 3 weeks cycles.~Capecitabine (1600 - 2500 mg/m2/day)/vinorelbine (60 to 80 mg/m2/day \[oral\] or (25 to 30 mg/m2 \[IV infusion\]"
Paclitaxel / Gemcitabine
"Paclitaxel (IV Infusion) / Gemcitabine (IV Infusion):~Paclitaxel via 3-hour intravenous (IV) infusion on Day 1 in 3-weeks cycles, OR Paclitaxel via 1 hour intravenous (IV) infusion on Day 1 and day 8- in 3-weeks cycles.~Gemcitabine at via 30 minute IV infusion on Day 1 and Day 8 in 3 weeks cycles.~Paclitaxel (175 mg/m2) (on Day 1 in 3-weeks cycles)/ gemcitabine (1000 - 1250 mg/m2)~OR~Paclitaxel (80 - 90 mg/m2) (on Day 1 and Day 8 in 3-weeks cycles) / gemcitabine (800 - 1250 mg/m2)"
Ribociclib
Dose: 600 mg (200 mg \* 3) Days 1 to 21 of each 28 day cycle Tablets for oral use
Letrozole OR Anastrozole
"Letrozole:~Dose: 2.5 mg All days of every cycle without interruption). Tablets for oral use~Anastrozole:~dose: 1 mg All days of every cycle without interruption. Tablets for oral use~The NSAI (letrozole or anastrozole) will be decided by the treating physician."
Goserelin
"Dose: 3.6 mg Day 1 of each 28 day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.~Subcutaneous implant"
Novartis Investigative Site, Taipei
Novartis Investigative Site, Saida
Novartis Investigative Site, Tripoli
Novartis Investigative Site, Durban
Novartis Investigative Site, Taipei
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Taipei
Novartis Investigative Site, Pulau Pinang
Novartis Investigative Site, Riyadh
Novartis Investigative Site, Taipei
Novartis Investigative Site, Giza
Novartis Investigative Site, Cairo
Novartis Investigative Site, Amman
Novartis Investigative Site, Cairo
Novartis Investigative Site, Taoyuan District
Novartis Investigative Site, Istanbul
Novartis Investigative Site, Izmir
Novartis Investigative Site, Taichung
Novartis Investigative Site, Malatya
Novartis Investigative Site, Chiang Mai
Novartis Investigative Site, Kuala Lumpur
Novartis Investigative Site, Tainan City
Novartis Investigative Site, Johor Bahru
Novartis Investigative Site, Kaohsiung City
Novartis Investigative Site, Kota Kinabalu
Novartis Investigative Site, Songkhla
Novartis Investigative Site, Kuching
Novartis Investigative Site, Hanoi
Novartis Investigative Site, New Delhi
Novartis Investigative Site, Moscow
Novartis Investigative Site, Moscow
Novartis Investigative Site, Singapore
Novartis Investigative Site, Singapore
Novartis Investigative Site, Pushkin Saint Petersburg
Novartis Investigative Site, Saint Petersburg
Novartis Investigative Site, Singapore
Novartis Investigative Site, Pune
Novartis Investigative Site, Hyderabad
Novartis Investigative Site, Kolkata
Novartis Investigative Site, Cairo
Novartis Investigative Site, Bangalore
Novartis Investigative Site, Mumbai
Novartis Investigative Site, Beirut
Novartis Investigative Site, Pretoria
Novartis Investigative Site, Pretoria
Novartis Investigative Site, Cankaya Ankara
Novartis Investigative Site, Kecioren Ankara
Novartis Investigative Site, Ankara
Novartis Investigative Site, Antalya
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY