NCT02705859View on ClinicalTrials.gov

Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study)

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

May 31, 2021

Study Completion Date

July 31, 2022

Conditions
HER2 Positive Breast Cancer
Interventions
DRUG

Copanlisib

Copanlisib is supplied as lyophilized preparation in a 6mL injection vial. The total amount of copanlisib per vial is 60mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered first over 60 minutes followed by the infusion of trastuzumab.

DRUG

Trastuzumab

Trastuzumab IV weekly (4mg/kg on Cycle 1 Day 1 followed by 2 mg/kg IV weekly from Day 8).

Trial Locations (3)

Unknown

Cancer Trials Ireland Investigative Site, Cork

Cancer Trials Ireland Investigative Site, Dublin

Cancer Trials Ireland Investigative Site, Galway

All Listed Sponsors
lead

Cancer Trials Ireland

NETWORK

NCT02705859 - Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study) | Biotech Hunter | Biotech Hunter