Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy
Metastatic HER2-Positive Breast Cancer
About this trial
This is an interventional treatment trial for Metastatic HER2-Positive Breast Cancer focused on measuring Gemcitabine,, Trastuzumab, Pertuzumab, 14-124
Eligibility Criteria
Inclusion Criteria:
- Age ≥ to 18
- Stage IV HER2 (+) breast cancer
- Histologically documented HER2 (+) breast cancer as defined as IHC 3+ or FISH amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable.
- lECOG performance status 0 -1
- Prior treatment with trastuzumab + pertuzumab (HP)-based therapy or pertuzumab-based in the neoadjuvantadjuvant, unresectable, locally advanced, or metastatic setting.
- ≤ 3 prior chemotherapies in the metastatic setting. Prior anthracycline, taxane, gemcitabine, and anti-HER2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib, TDM-1, etc.) are allowed. If patients received prior gemcitabine, it could not have been combined with pertuzumab. Patients should have progression of disease on current therapy.
- Measurable or non-measurable disease.
- LVEF ≥ 50%
- Hematologic parameters: white blood cell (WBC) count of ≥ 3000/ul, absolute neutrophil count (ANC) ≥ 1000/ul, platelets ≥ 100,000/ul, hemoglobin ≥10.0 g/dl
- Non-hematologic parameters: bilirubin ≤ 1.5 mg/dl, AST/ALT≤ 2.5 x upper limit of normal (ULN), alkaline phosphatase ≤ 5 x ULN.
- Creatinine ≤ 1.5 mg/dl
- Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled.
Exclusion Criteria:
- History of prior unstable angina, myocardial infarction, CHF, uncontrolled ventricular arrhythmias within 12 months
- History of prior ≥ G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
- History of hepatitis B or C
- Pregnant patients
Sites / Locations
- Hartford Healthcare Cancer Institute @ Hartford Hospital
- Memorial Sloan Kettering at Basking Ridge
- Memorial Sloan Kettering Monmouth
- Memorial Sloan Kettering Westchester
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Gemcitabine, Trastuzumab, and Pertuzuma
The regimen will consist of gemcitabine at 1000mg/m^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it < 6 weeks prior to Cycle 1 Day 1.