NCT02705859

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

Phase Ib/II Clinical Trial of Copanlisib in Combination With Trastuzumab in Pretreated Recurrent or Metastatic HER2-positive Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Cancer Trials Ireland · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Phase Ib One of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. Phase II The copanlisib dose for the Phase II part of the trial will be based on the MTD established in the Phase Ib part of the study. Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed throughout the study. Efficacy assessments (radiological examination) will be performed on all patients every 8 weeks for the first 24 weeks and every 12 weeks thereafter. Following baseline cardiac assessment, cardiac safety monitoring will include physical exam (with New York Heart Association (NYHA) functional classification for patients with diagnosed congestive heart failure) during each cycle, Multigated acquisition (MUGA) scan or Echocardiogram (ECHO) and 12 lead Electrocardiogram (ECG) within 7 days of Day 1 of every third cycle starting at cycle 3 (Cycle 3, Cycle 6, etc.).

Conditions

• HER2 Positive Breast Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2016-04-01
• Primary completion: 2021-05-01
• Completion: 2022-07-01
• First posted: 2016-03-11
• Last updated: 2026-04-13

Locations

3 sites across 1 country: Ireland