Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to evaluate the safety and activity of gemcitabine plus trastuzumab and pertuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)+ breast cancer who have progressed on at least one prior line of chemotherapy plus HER2 targeted agent such as T-DM1, trastuzumab, or lapatinib.

Key facts

Study ID

NCT02139358

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

15

Starts

2014-09-05

Expected to finish

2020-03-16

Last updated by the study team

2021-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult males or females (aged 18 or older) with histologically confirmed, metastatic human epidermal growth factor receptor 2 (HER2)+ (by immunohistochemistry (IHC) 3+ or fluorescence in situ hydridization (FISH) ratio ≥ 2.0) breast cancer
• Have progressed on at least one prior line of chemotherapy plus HER2 directed therapy such as trastuzumab and/or pertuzumab in the metastatic setting. T-DM1 would count as a line of therapy and patients previously treated with T-DM1 are eligible.
• Have not been treated with gemcitabine in the metastatic setting
• Measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 2≤
• Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
• Adequate bone marrow function as indicated by the following: absolute neutrophil count (ANC) >1500/µL; Platelets ≥100,000/µL; Hemoglobin >10 g/dL
• Adequate renal function, as indicated by creatinine ≤1.5x upper limit of normal (ULN)
• Adequate liver function, as indicated by bilirubin ≤1.5x ULN, aspartic transaminase (AST) or alanine transaminase (ALT) <2x ULN unless related to metastatic breast cancer to the liver (in which case AST/ALT < 5x ULN is allowed).
• Signed informed consent
• Adequate birth control in sexually active women of childbearing potential

You may not qualify if…

• Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the participant unsafe to proceed with the study
• Uncontrolled central nervous system (CNS) metastases. Treated, non-progressing CNS disease (documented by brain magnetic resonance imaging [MRI]) off corticosteroids for at least 1 month potential participants are eligible.
• Women who are pregnant or lactating
• Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
• Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation)
• Other concomitant active malignancies
• History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
• Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower
• Hypersensitivity to any of the study medications
• Untreated psychiatric conditions preventing informed consent

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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