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We began analyzing https://link.springer.com/article/10.1007/s00280-009-0975-z, but it redirected us to https://link.springer.com/article/10.1007/s00280-009-0975-z. The analysis below is for the second page.

Title[redir]:
A randomized, phase II, dose-finding study of the pan-ErbB receptor tyrosine-kinase inhibitor CI-1033 in patients with pretreated metastatic breast cancer | Cancer Chemotherapy and Pharmacology
Description:
To evaluate the efficacy and safety of the pan-ErbB receptor tyrosine-kinase inhibitor CI-1033 in metastatic breast cancer (MBC). Patients with measurable, progressive, or recurrent MBC whose primary tumor expressed ≥1 ErbB receptor were randomized to the following CI-1033 regimens: 50 mg (arm A) or 150 mg (arm B) daily without rest period, or 450 mg/day × 14 days every 21 days (arm C). The primary endpoint was 1-year progression-free survival (PFS). Overall, 194 patients were treated. One-year PFS estimates were 3.8, 2.0, and 4.6%; median PFS was 61, 56, and 58 days; and investigator-assessed overall response rates were 1.5, 1.5, and 7.3%, in arms A, B, and C, respectively. Response duration was 110–419 days. In arm C, response (18.8 vs. 2.6%) and 1-year overall survival rates (86.7 vs. 47.5%) were greater in patients with HER2-positive versus HER2-negative tumors. The incidence of grade 3/4 adverse events (AEs) was dose-dependent, affecting 10.3, 48.6, and 80.4% of patients in arms A, B and C, respectively. The most common grade 3/4, treatment-related AEs were diarrhea, asthenia, and stomatitis. Arm C enrollment was prematurely discontinued due to a high frequency of grade 3/4 AEs. Single-agent CI-1033 did not show clinically meaningful activity in heavily pretreated patients with MBC expressing ≥1 ErbB receptor. Antitumor activity was observed in arm C patients with HER2-positive tumors. However, only the 50 mg dose was well tolerated, and the highest dose reached unacceptable levels of toxicity.

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Keywords {🔍}

cancer, article, google, scholar, patients, breast, pubmed, phase, cas, study, clin, metastatic, receptor, oncol, inhibitor, panerbb, research, usa, randomized, advanced, rixe, efficacy, safety, arm, access, tyrosine, treatment, clinical, privacy, cookies, content, abstract, herpositive, tumors, trastuzumab, kinase, oral, res, institute, multicenter, trial, center, publish, search, chemotherapy, tyrosinekinase, olivier, franco, stephen, days,

Topics {✒️}

androgen receptor-positive metastatic irreversible pan-erbb inhibitor month download article/chapter tyrosine kinase inhibitor metastatic breast cancer receptor tyrosine kinases her2-positive tumors small-cell lung cancer advanced breast cancer 1-year progression-free survival article cancer chemotherapy pharmacology article full article pdf advanced solid tumors national cancer institute anticancer therapies previously treated advanced privacy choices/manage cookies phase ii trial breast cancer related subjects phase ii study tumor pharmacodynamic study study center staff acknowledge editorial support article rixe heavily pretreated patients european economic area check access instant access clinical research department refractory cancer dose-finding study pharmacology aims prematurely discontinued due food effect study /food effect study critical end point lo russo pm open-label m77001 study group clinical trial team cancer research conditions privacy policy clinical oncology/college dr patrice herait california san francisco metastatic disease treatment-related aes article log

Questions {❓}

Rixe O, Fojo T (2007) Is cell death a critical end point for anticancer therapies or is cytostasis sufficient?

Schema {🗺️}

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