scholarly journals A virosomal formulated Her-2/neu multi-peptide vaccine induces Her-2/neu-specific immune responses in patients with metastatic breast cancer: a phase I study

2009 ◽  
Vol 119 (3) ◽  
pp. 673-683 ◽  
Author(s):  
Ursula Wiedermann ◽  
C. Wiltschke ◽  
J. Jasinska ◽  
M. Kundi ◽  
R. Zurbriggen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Immune Responses ◽  
Phase I ◽  
Phase I Study ◽  
Peptide Vaccine ◽  
Metastatic Breast ◽  
Her 2

Treatment With Autologous Antigen-Presenting Cells Activated With the HER-2 –Based Antigen Lapuleucel-T: Results of a Phase I Study in Immunologic and Clinical Activity in HER-2–Overexpressing Breast Cancer

2007 ◽  
Vol 25 (24) ◽  
pp. 3680-3687 ◽  
Author(s):  
John W. Park ◽  
Michelle E. Melisko ◽  
Laura J. Esserman ◽  
Lori A. Jones ◽  
Jami Breen Wollan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Immune Responses ◽  
Phase I ◽  
Phase I Study ◽  
Metastatic Breast ◽  
Cellular Immunotherapy ◽  
Her 2 ◽  
Immunologic Activity ◽  
Antigen Presenting

Purpose Lapuleucel-T (APC8024), an autologous active cellular immunotherapy, was prepared from peripheral-blood mononuclear cells, including antigen-presenting cells, that were activated in vitro with recombinant fusion protein BA7072. This antigen construct consisted of sequences from intracellular and extracellular domains of human epidermal growth factor receptor 2 (HER-2) linked to granulocyte-macrophage colony-stimulating factor. We conducted a phase I study to evaluate the safety and immunologic activity of lapuleucel-T in patients with HER-2–overexpressing metastatic breast cancer. Patients and Methods Metastatic breast cancer patients whose tumors overexpressed or amplified HER-2 were eligible. Patients underwent leukapheresis and subsequent lapuleucel-T infusion 2 days later at weeks 0, 2, and 4. Patients who achieved a partial response (PR) or had stable disease (SD) lasting through week 48 were eligible for re-treatment using the same protocol and dose as their initial treatment. End points included safety, immunologic activity, and antitumor activity. Results Nineteen patients were enrolled; 18 patients received treatment. Therapy was well tolerated, with no grade 3 or 4 adverse events associated with the treatment. Significant cellular immune responses specific for the immunizing antigen and HER-2 sequences were induced after treatment, as measured by lymphocyte proliferation and interferon gamma enzyme-linked immunospot assay. One patient experienced a PR lasting 6 months. Three additional patients had SD lasting more than 1 year. Conclusion Autologous active cellular immunotherapy with lapuleucel-T was feasible, safe, and well tolerated. The treatment stimulated significant immune responses, which were enhanced after boost infusions. Lapuleucel-T therapy was associated with tumor response or extended disease stabilization in some patients and warrants further investigation.

A phase I study of a PD-L1 antibody (Durvalumab) in combination with trastuzumab in HER-2 positive metastatic breast cancer (MBC) progressing on prior anti HER-2 therapies (CCTG IND.229)[NCT02649686].

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 1029-1029 ◽  
Author(s):  
Stephen K. L. Chia ◽  
Philippe L. Bedard ◽  
John Hilton ◽  
Eitan Amir ◽  
Karen A. Gelmon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Metastatic Breast ◽  
Her 2

Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer

2021 ◽  
Author(s):  
Filipa Lynce ◽  
James T. Williams ◽  
Meredith M. Regan ◽  
Craig A. Bunnell ◽  
Rachel A. Freedman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Metastatic Breast ◽  
Weekly Paclitaxel

scholarly journals A Phase I Study of Pemetrexed (ALIMTA) and Cyclophosphamide in Patients with Locally Advanced or Metastatic Breast Cancer

2006 ◽  
Vol 12 (23) ◽  
pp. 7071-7078 ◽  
Author(s):  
Christian Dittrich ◽  
Lubos Petruzelka ◽  
Pavel Vodvarka ◽  
Margit Gneist ◽  
Filip Janku ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Metastatic Breast

scholarly journals Phase I Study of Panobinostat (LBH589) and Letrozole in Postmenopausal Metastatic Breast Cancer Patients

2016 ◽  
Vol 16 (2) ◽  
pp. 82-86 ◽  
Author(s):  
Winston W. Tan ◽  
Jacob B. Allred ◽  
Alvaro Moreno-Aspitia ◽  
Donald W. Northfelt ◽  
James N. Ingle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Study ◽  
Metastatic Breast ◽  
Breast Cancer Patients

Prospective open uncontrolled phase I study to define a well-tolerated dose of oral artesunate as add-on therapy in patients with metastatic breast cancer (ARTIC M33/2)

2017 ◽  
Vol 164 (2) ◽  
pp. 359-369 ◽  
Author(s):  
Cornelia von Hagens ◽  
Ingeborg Walter-Sack ◽  
Maren Goeckenjan ◽  
Julia Osburg ◽  
Brigitte Storch-Hagenlocher ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Metastatic Breast

370 Taxol® (paclitaxel) and farmorubicin® (epirubicin) in metastatic breast cancer (MBC): Preliminary results of a phase I study

1995 ◽  
Vol 31 ◽  
pp. S80-S81
Author(s):  
M. Spielmann ◽  
G. Catimel ◽  
L. Kayitalire ◽  
P. Pouillart ◽  
A. Dumortier ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Metastatic Breast ◽  
Preliminary Results

A Phase I Study of Capecitabine Combined with CPT-11 in Metastatic Breast Cancer Pretreated with Anthracyclines and Taxanes

Oncology ◽  
2014 ◽  
Vol 86 (4) ◽  
pp. 206-211 ◽  
Author(s):  
Masahiro Kashiwaba ◽  
Toru Inaba ◽  
Hideaki Komatsu ◽  
Kazushige Ishida ◽  
Ryoko Kawagishi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Metastatic Breast
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