PMID- 30106636
OWN - NLM
STAT- MEDLINE
DCOM- 20190913
LR  - 20190913
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 36
IP  - 28
DP  - 2018 Oct 1
TI  - First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, 
      in Human Epidermal Growth Factor Receptor 2-Positive and Hormone 
      Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A 
      Randomized, Open-Label Phase II Trial.
PG  - 2826-2835
LID - 10.1200/JCO.2017.76.7863 [doi]
AB  - PURPOSE: To assess pertuzumab plus trastuzumab and an aromatase inhibitor (AI) in 
      patients with human epidermal growth factor receptor 2 (HER2)-positive and 
      hormone receptor-positive metastatic/locally advanced breast cancer (MBC/LABC). 
      PATIENTS AND METHODS: The PERTAIN trial (NCT01491737) is an ongoing randomized, 
      open-label, multicenter-80 sites and eight countries-phase II trial. Patients 
      have HER2-positive, hormone receptor-positive MBC/LABC and no prior systemic 
      therapy with the exception of endocrine. Random assignment was 1:1 to intravenous 
      pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks) plus 
      trastuzumab (8 mg/kg followed by 6 mg/kg every 3 weeks), and oral anastrozole (1 
      mg every day) or letrozole (2.5 mg every day), or trastuzumab and an AI. 
      Induction intravenous docetaxel every 3 weeks or paclitaxel every week could be 
      administered for 18 to 24 weeks at the investigator's discretion (decided before 
      but given after random assignment). Primary end point was progression-free 
      survival (PFS). Patients were stratified by whether they received induction 
      chemotherapy and their time since adjuvant hormone therapy. RESULTS: One hundred 
      twenty-nine patients were randomly assigned per arm (February 2012 to October 
      2014; intent-to-treat populations); 75 in one arm and 71 in the other were chosen 
      to receive induction chemotherapy. Stratified median PFS was 18.89 months (95% 
      CI, 14.09 to 27.66 months) in the pertuzumab plus trastuzumab arm and 15.80 
      months (95% CI, 11.04 to 18.56 months) in the trastuzumab arm (stratified hazard 
      ratio, 0.65; 95% CI, 0.48 to 0.89; P = .0070). Serious adverse events (AEs) were 
      reported for 42 (33.1%) of 127 and 24 (19.4%) of 124 patients in the safety 
      populations of the pertuzumab plus trastuzumab and trastuzumab arms, 
      respectively. Rates of grade >/= 3 AEs were 64 (50.4%) of 127 and 48 (38.7%) of 
      124, respectively. There were no deaths as a result of AEs. CONCLUSION: PERTAIN 
      met its primary PFS end point. Pertuzumab plus trastuzumab and an AI is effective 
      for the treatment of HER2-positive MBC/LABC. The safety profile was consistent 
      with previous trials of pertuzumab plus trastuzumab.
FAU - Rimawi, Mothaffar
AU  - Rimawi M
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Ferrero, Jean-Marc
AU  - Ferrero JM
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - de la Haba-Rodriguez, Juan
AU  - de la Haba-Rodriguez J
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Poole, Christopher
AU  - Poole C
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - De Placido, Sabino
AU  - De Placido S
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Osborne, C Kent
AU  - Osborne CK
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Hegg, Roberto
AU  - Hegg R
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Easton, Valerie
AU  - Easton V
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Wohlfarth, Christine
AU  - Wohlfarth C
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Arpino, Grazia
AU  - Arpino G
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
CN  - PERTAIN Study Group
AD  - Mothaffar Rimawi and C. Kent Osborne, Baylor College of Medicine, Houston, TX; 
      Jean-Marc Ferrero, Centre Antoine Lacassagne, Nice, France; Juan de la 
      Haba-Rodriguez, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain; 
      Christopher Poole, University Hospitals Coventry; Christopher Poole, Warwickshire 
      National Health Service Trust, Coventry, United Kingdom; Sabino De Placido and 
      Grazia Arpino, University Federico II, Naples, Italy; Roberto Hegg, Hospital 
      Perola Byington; Roberto Hegg, Faculdade de Medicina da Universidade de Sao 
      Paulo, Sao Paulo, Brazil; and Valerie Easton and Christine Wohlfarth, F. 
      Hoffmann-La Roche Ltd., Basel, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT01491737
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180814
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Aromatase Inhibitors)
RN  - 0 (Receptors, Estrogen)
RN  - 0 (Receptors, Progesterone)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - K16AIQ8CTM (pertuzumab)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Aromatase Inhibitors/*administration & dosage/adverse effects
MH  - Breast Neoplasms/*drug therapy/mortality
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Progression-Free Survival
MH  - Receptor, ErbB-2/biosynthesis
MH  - Receptors, Estrogen/biosynthesis
MH  - Receptors, Progesterone/biosynthesis
MH  - Trastuzumab/*administration & dosage/adverse effects
EDAT- 2018/08/15 06:00
MHDA- 2019/09/14 06:00
CRDT- 2018/08/15 06:00
PHST- 2018/08/15 06:00 [pubmed]
PHST- 2019/09/14 06:00 [medline]
PHST- 2018/08/15 06:00 [entrez]
AID - 10.1200/JCO.2017.76.7863 [doi]
PST - ppublish
SO  - J Clin Oncol. 2018 Oct 1;36(28):2826-2835. doi: 10.1200/JCO.2017.76.7863. Epub 
      2018 Aug 14.