Abstract
Introduction:
Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer. We present a phase I trial of a novel selective agent, nintedanib, plus standard chemotherapy in early breast cancer.
Methods:
Her-2-negative breast cancer patients with tumours larger than 2 cm were eligible for dose-escalation trial (classic 3+3 method).
Results:
The recommended phase II dose (RP2D) was 150 mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide. The dose-limiting toxicity was transaminase elevation. At the RP2D, the dose intensity was ∼100%. The pathologic complete response was 50%.
Conclusions:
The combination allows the delivery of full-dose intensity, while efficacy seems promising.
Publication types
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Clinical Trial, Phase I
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Alanine Transaminase / blood
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects*
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Aspartate Aminotransferases / blood
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Breast Neoplasms / chemistry
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Breast Neoplasms / drug therapy*
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Cyclophosphamide / administration & dosage
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Doxorubicin / administration & dosage
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Female
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Humans
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Indoles / administration & dosage
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Indoles / adverse effects
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Lymphopenia / chemically induced
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Maximum Tolerated Dose
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Middle Aged
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Neoadjuvant Therapy
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Neutropenia / chemically induced
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Paclitaxel / administration & dosage
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Prospective Studies
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Receptor, ErbB-2 / analysis
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Treatment Outcome
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gamma-Glutamyltransferase / blood
Substances
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Indoles
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Doxorubicin
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Cyclophosphamide
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gamma-Glutamyltransferase
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Aspartate Aminotransferases
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Alanine Transaminase
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ERBB2 protein, human
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Receptor, ErbB-2
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nintedanib
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Paclitaxel