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

NCT02705859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-04-13

No results posted yet for this study

Summary

This study is a Phase Ib/II open label, single arm, adaptive multi-centre trial of copanlisib in combination with trastuzumab in pretreated recurrent or metastatic HER2-positive breast cancer.

Patients with HER2 positive, metastatic or incurable recurrent breast cancer, following disease progression during, or after, treatment with at least one systemic treatment regimen in the metastatic or recurrent setting, will be treated with copanlisib (at 30, 45 or 60 mg flat dosing IV weekly - depending on the maximum tolerated dose (MTD) determined in the Phase Ib part of the study) plus trastuzumab (4 mg/kg IV Cycle 1 Day 1 and then 2 mg/kg IV weekly starting from day 8).

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).

Sponsors & Collaborators

  • Cancer Trials Ireland

    lead NETWORK

Principal Investigators

  • Cancer Trials Ireland Dublin 11, Ireland · Cancer Trials Ireland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-05-31
Completion
2022-07-31

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02705859 on ClinicalTrials.gov