PMID- 26975189
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20210102
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
VI  - 156
IP  - 2
DP  - 2016 Apr
TI  - A phase I/II trial of the safety and clinical activity of a HER2-protein based 
      immunotherapeutic for treating women with HER2-positive metastatic breast cancer.
PG  - 301-10
LID - 10.1007/s10549-016-3750-y [doi]
AB  - The objectives of this phase I/II study (NCT00140738) were to evaluate the safety 
      and clinical activity of a cancer immunotherapeutic agent (recombinant HER2 
      protein (dHER2) and the immunostimulant AS15) in patients with 
      HER2-overexpressing metastatic breast cancer (MBC). Forty HER2-positive MBC 
      patients received up to 18 doses (12q2w, 6q3w) of dHER2 immunotherapeutic, as 
      first- or second-line therapy following response to trastuzumab-based treatment 
      as maintenance. Toxicity was graded by the Common Terminology Criteria for 
      Adverse Events (CTCAE) and clinical activity was evaluated by target lesion 
      assessment according to the Response Evaluation Criteria in Solid Tumors 
      (RECIST). Immunogenicity was assessed. The dHER2 immunotherapeutic was well 
      tolerated: grade 1/2 adverse events (AEs) were most common. No cardiac events 
      were observed and one patient experienced an asymptomatic decrease of left 
      ventricular ejection fraction below the normal range (47 %). Both humoral and 
      cellular immunogenicity to the dHER2 antigen was observed. No patient 
      discontinued the immunizations because of AEs but 35/40 withdrew prematurely, 34 
      because of disease progression (24/34 before or at the tumor assessment after 
      dose 6). One patient achieved a complete response lasting 11 months and one 
      patient had a partial response lasting 3.5 months. Ten patients experienced 
      stable disease >/=26 weeks with 4/10 still in stable disease at the last tumor 
      assessment after 47 weeks. Immunization of MBC patients with the dHER2 
      immunotherapeutic was associated with minimal toxicity and no cardiac events. 
      Clinical activity was observed with two objective responses and prolonged stable 
      disease for 10/40 patients.
FAU - Curigliano, Giuseppe
AU  - Curigliano G
AD  - Early Drug Development for Innovative Therapies Division, Istituto Europeo di 
      Oncologica di Milano, Via Ripamonti, 435, 20141, Milan, Italy. 
      giuseppe.curigliano@ieo.it.
FAU - Romieu, Gilles
AU  - Romieu G
AD  - Institut regional du Cancer de Montpellier, Montpellier, France.
FAU - Campone, Mario
AU  - Campone M
AD  - Institut de Cancerologie de l'Ouest, Nantes, France.
FAU - Dorval, Thierry
AU  - Dorval T
AD  - Department of Medical Oncology, Institut Curie, Paris, France.
FAU - Duck, Lionel
AU  - Duck L
AD  - Department of Medical Oncology, Clinique Saint-Pierre, Ottignies, Belgium.
FAU - Canon, Jean-Luc
AU  - Canon JL
AD  - Oncology-Hematology Department, Grand Hopital de Charleroi, Charleroi, Belgium.
FAU - Roemer-Becuwe, Celia
AU  - Roemer-Becuwe C
AD  - Centre d'Oncologie de Gentilly, Nancy, France.
FAU - Roselli, Mario
AU  - Roselli M
AD  - Medical Oncology Unit, 'Tor Vergata' University Hospital, Rome, Italy.
FAU - Neciosup, Silvia
AU  - Neciosup S
AD  - Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.
FAU - Burny, Wivine
AU  - Burny W
AD  - GSK Vaccines, Rixensart, Belgium.
FAU - Callegaro, Andrea
AU  - Callegaro A
AD  - GSK Vaccines, Rixensart, Belgium.
FAU - de Sousa Alves, Pedro Miguel
AU  - de Sousa Alves PM
AD  - GSK Vaccines, Rixensart, Belgium.
FAU - Louahed, Jamila
AU  - Louahed J
AD  - GSK Vaccines, Rixensart, Belgium.
FAU - Brichard, Vincent
AU  - Brichard V
AD  - GSK Vaccines, Rixensart, Belgium.
FAU - Lehmann, Frederic F
AU  - Lehmann FF
AD  - GSK Vaccines, Rixensart, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT00140738
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160314
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Recombinant Proteins)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage/adverse effects
MH  - Antineoplastic Agents/*administration & dosage/therapeutic use
MH  - Breast Neoplasms/metabolism/*therapy
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Immunotherapy
MH  - Middle Aged
MH  - Receptor, ErbB-2/genetics/*metabolism
MH  - Recombinant Proteins/*administration & dosage/adverse effects
MH  - Trastuzumab/*administration & dosage/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Breast cancer
OT  - Cancer immunotherapeutic
OT  - HER2 antigen
OT  - Vaccine
EDAT- 2016/03/16 06:00
MHDA- 2016/12/15 06:00
CRDT- 2016/03/16 06:00
PHST- 2016/03/03 00:00 [received]
PHST- 2016/03/07 00:00 [accepted]
PHST- 2016/03/16 06:00 [entrez]
PHST- 2016/03/16 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - 10.1007/s10549-016-3750-y [pii]
AID - 10.1007/s10549-016-3750-y [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2016 Apr;156(2):301-10. doi: 10.1007/s10549-016-3750-y. 
      Epub 2016 Mar 14.