Status:
COMPLETED
Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Hoffmann-La Roche
Conditions:
Metastatic HER2-Positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if a combination of drugs can help to treat breast cancer. This is a Phase II study which will test whether this combination of drugs is effective and will provide ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02252887
Start Date
January 12 2015
End Date
July 24 2025
Last Update
July 25 2025
Active Locations (5)
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1
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States, 06102
2
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604