Open label, randomized, phase II study of pertuzumab (P) in patients (pts) with metastatic breast cancer (MBC) with low expression of HER2

Cortés, J.; Baselga, J.; Kellokumpu-Lehtinen, P.; Bianchi, Giulia; Cameron, D; Miles, David; Salvagni, Stefania; Wardley, Andrew M; Goeminne, J-C; Giannì, L.

doi:10.1200/jco.2005.23.16_suppl.3068

Cited by 26 publications

(15 citation statements)

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“…The pharmacokinetics of pertuzumab are similar to those observed in previous phase I studies of pertuzumab alone (20), and with phase II data using the same 1,050 mg dose (37,38). This can be explained because both drugs have different clearance mechanisms.…”

Section: Discussionsupporting

confidence: 71%

A Phase I Study of the Safety and Pharmacokinetics of the Combination of Pertuzumab (rhuMab 2C4) and Capecitabine in Patients with Advanced Solid Tumors

Albanell

Montagut

Jones³

et al. 2008

Clinical Cancer Research

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Purpose: To study the safety, pharmacokinetics, and recommended dose of the combination of pertuzumab, a humanized monoclonal antibody HER2-dimerization inhibitor, and capecitabine in patients with advanced malignancies. Experimental Design: Patients that had progressed to standard treatment were treated with pertuzumab at a fixed dose of 1,050 mg given i.v. on day 1 plus capecitabine at doses of 825-1,000-1,250 mg/m 2 , twice daily orally on days 1 to 14 of each 21-day treatment cycle, in three sequential cohorts. The pharmacokinetics of capecitabine and pertuzumab were studied. Patients received a single dose of capecitabine in a pretreatment phase (day -7) followed by serum sampling for capecitabine and its metabolites. Results: Nineteen patients were accrued and 18 were assessable. The combination of capecitabine and pertuzumab was well tolerated at all dose levels and no dose-limiting toxicities were observed. The most frequent adverse event was asthenia, which was grade 3 in two patients. One asymptomatic pulmonary embolism occurred. No other grade 3 or 4 adverse events or cardiac or left ventricular ejection fraction events were reported. There was no apparent change in the pharmacokinetics of capecitabine and its metabolites when combined with pertuzumab. The pharmacokinetics of pertuzumab was apparently not modified when administered with capecitabine. Disease stabilization was observed in 11patients. Conclusions: Pertuzumab and capecitabine were well tolerated at all dose levels. Escalation beyond the highest dose level tested was not planned, as this included the recommended doses of monotherapy for both drugs. In conclusion, this combination is ready for phase II testing.

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Section: Discussionsupporting

confidence: 71%

A Phase I Study of the Safety and Pharmacokinetics of the Combination of Pertuzumab (rhuMab 2C4) and Capecitabine in Patients with Advanced Solid Tumors

Albanell

Montagut

Jones³

et al. 2008

Clinical Cancer Research

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show abstract

“…To date several phase II trials evaluating pertuzumab have been completed. Initial results evaluating pertuzumab as monotherapy in metastatic breast cancer and hormone-refractory prostate cancer were not promising as there was limited evidence of activity in breast cancer patients and no prostate-specific antigen responses in the prostate cancer (Cortes et al, 2005;de Bono et al, 2005). However, more promising results in refractory or recurrent ovarian cancer have been seen in which clinical activity was seen in 15% of patients .…”

Section: Targeting the Raf-mek-erk Mapk Cascade Pj Roberts And Cj Dermentioning

confidence: 98%

Targeting the Raf-MEK-ERK mitogen-activated protein kinase cascade for the treatment of cancer

2007

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“…mAb 2C4 has been modified for human clinical use by recombinant engineering to generate the humanized version pertuzumab (Adams et al, 2006). Pertuzumab is currently undergoing clinical trials and preliminary evidence suggests that it can enhance the efficacy of trastuzumab, but its single agent activity in HER2 overexpressing breast cancer is not yet known (Baselga et al, 2007), Pertuzumab has little activity in breast cancers without HER2 overexpression and in unselected ovarian cancers (Cortes et al, 2005;Fleming et al, 2005).…”

Section: Mechanism Of Action Of Trastuzumab -Immunological Targetingmentioning

confidence: 99%

Targeting the function of the HER2 oncogene in human cancer therapeutics

2007

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Open label, randomized, phase II study of pertuzumab (P) in patients (pts) with metastatic breast cancer (MBC) with low expression of HER2

Cited by 26 publications

References 0 publications

A Phase I Study of the Safety and Pharmacokinetics of the Combination of Pertuzumab (rhuMab 2C4) and Capecitabine in Patients with Advanced Solid Tumors

A Phase I Study of the Safety and Pharmacokinetics of the Combination of Pertuzumab (rhuMab 2C4) and Capecitabine in Patients with Advanced Solid Tumors

Targeting the Raf-MEK-ERK mitogen-activated protein kinase cascade for the treatment of cancer

Targeting the function of the HER2 oncogene in human cancer therapeutics

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