Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (… (NCT02705859) | Clinical Trial Compass
CompletedPhase 1
Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study)
Ireland26 participantsStarted 2016-04
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Adult women ≥ 18 years of age.
✓. Histologically confirmed HER2-positive breast cancer:
✓. Recurrent incurable or metastatic breast cancer:
✓. At least one measurable lesion according to RECIST criteria (Version 1.1). Patients with bone only disease are not eligible.
✓. Patient has received at least one trastuzumab-based or T-DM1-based treatment regimen in the setting of metastatic disease or incurable locoregional recurrence. A trastuzumab-based or T-DM1-based treatment regimen is considered as any treatment regimen that includes trastuzumab or T-DM1.
✓. Disease progression during or following at least 1 prior trastuzumab-based or trastuzumab emtansine (T-DM1) based treatment regimen in the setting of metastatic disease or incurable locoregional recurrence.
✓. ECOG performance status ≤ 2.
✓. Life expectancy of at least 3 months.
Exclusion criteria
✕
What they're measuring
1
Maximum Tolerated Dose of copanlisib in combination with trastuzumab measured by the incidence of dose limiting toxicity (DLT) of copanlisib in combination with trastuzumab within the 1st cycle at each dose level.
Timeframe: 1 year
2
Clinical Benefit Rate, defined as complete response (CR) or partial response (PR) at any time-point on the study; or stable disease (SD) lasting at least 24 weeks based on radiological assessment.
. Known breast cancer involvement of the brain, unless adequately controlled based on the clinical judgement of the treating physician.
✕. Congestive heart failure \> New York Heart Association (NYHA) class II.
✕. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before registration.
✕. Uncontrolled Type I or II diabetes mellitus. Defined as HbA1c \> 8.5% as determined during screening laboratory assessments.
✕. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before registration.