|
1
|
Slamon DJ, Clark GM, Wong SG, Levin WJ,
Ullrich A and McGuire WL: Human breast cancer: Correlation of
relapse and survival with amplification of the HER-2/neu oncogene.
Science. 235:177–182. 1987. View Article : Google Scholar : PubMed/NCBI
|
|
2
|
Slamon DJ, Godolphin W, Jones LA, Holt JA,
Wong SG, Keith DE, Levin WJ, Stuart SG, Udove J, Ullrich A, et al:
Studies of the HER-2/neu proto-oncogene in human breast and ovarian
cancer. Science. 244:707–712. 1989. View Article : Google Scholar : PubMed/NCBI
|
|
3
|
Gusterson BA, Gelber RD, Goldhirsch A,
Price KN, Säve-Söderborgh J, Anbazhagan R, Styles J, Rudenstam CM,
Golouh R, Reed R, et al: International (Ludwig) Breast Cancer Study
Group: Prognostic importance of c-erbB-2 expression in breast
cancer. J Clin Oncol. 10:1049–1056. 1992.PubMed/NCBI
|
|
4
|
Seshadri R, Firgaira FA, Horsfall DJ,
McCaul K, Setlur V and Kitchen P: The South Australian Breast
Cancer Study Group: Clinical significance of HER-2/neu oncogene
amplification in primary breast cancer. J Clin Oncol. 11:1936–1942.
1993.PubMed/NCBI
|
|
5
|
Ravdin PM and Chamness GC: The c-erbB-2
proto-oncogene as a prognostic and predictive marker in breast
cancer: A paradigm for the development of other macromolecular
markers - a review. Gene. 159:19–27. 1995. View Article : Google Scholar : PubMed/NCBI
|
|
6
|
Press MF, Bernstein L, Thomas PA, Meisner
LF, Zhou JY, Ma Y, Hung G, Robinson RA, Harris C, El-Naggar A, et
al: HER-2/neu gene amplification characterized by fluorescence in
situ hybridization: Poor prognosis in node-negative breast
carcinomas. J Clin Oncol. 15:2894–2904. 1997.PubMed/NCBI
|
|
7
|
Slamon DJ, Leyland-Jones B, Shak S, Fuchs
H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M,
et al: Use of chemotherapy plus a monoclonal antibody against HER2
for metastatic breast cancer that overexpresses HER2. N Engl J Med.
344:783–792. 2001. View Article : Google Scholar : PubMed/NCBI
|
|
8
|
Piccart-Gebhart MJ, Procter M,
Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga
J, Bell R, Jackisch C, et al: Herceptin Adjuvant (HERA) Trial Study
Team: Trastuzumab after adjuvant chemotherapy in HER2-positive
breast cancer. N Engl J Med. 353:1659–1672. 2005. View Article : Google Scholar : PubMed/NCBI
|
|
9
|
Gianni L, Dafni U, Gelber RD, Azambuja E,
Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch
C, et al: Herceptin Adjuvant (HERA) Trial Study Team: Treatment
with trastuzumab for 1 year after adjuvant chemotherapy in patients
with HER2-positive early breast cancer: A 4-year follow-up of a
randomised controlled trial. Lancet Oncol. 12:236–244. 2011.
View Article : Google Scholar : PubMed/NCBI
|
|
10
|
Goldhirsch A, Gelber RD, Piccart-Gebhart
MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D,
Weber HA, Heinzmann D, et al: Herceptin Adjuvant (HERA) Trial Study
Team: 2 years versus 1 year of adjuvant trastuzumab for
HER2-positive breast cancer (HERA): An open-label, randomised
controlled trial. Lancet. 382:1021–1028. 2013. View Article : Google Scholar : PubMed/NCBI
|
|
11
|
Agus DB, Akita RW, Fox WD, Lewis GD,
Higgins B, Pisacane PI, Lofgren JA, Tindell C, Evans DP, Maiese K,
et al: Targeting ligand-activated ErbB2 signaling inhibits breast
and prostate tumor growth. Cancer Cell. 2:127–137. 2002. View Article : Google Scholar : PubMed/NCBI
|
|
12
|
Hughes JB, Berger C, Rødland MS, Hasmann
M, Stang E and Madshus IH: Pertuzumab increases epidermal growth
factor receptor down-regulation by counteracting epidermal growth
factor receptor-ErbB2 heterodimerization. Mol Cancer Ther.
8:1885–1892. 2009. View Article : Google Scholar : PubMed/NCBI
|
|
13
|
Baselga J, Cortés J, Kim SB, Im SA, Hegg
R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, et al:
CLEOPATRA Study Group: Pertuzumab plus trastuzumab plus docetaxel
for metastatic breast cancer. N Engl J Med. 366:109–119. 2012.
View Article : Google Scholar : PubMed/NCBI
|
|
14
|
Citri A, Skaria KB and Yarden Y: The deaf
and the dumb: The biology of ErbB-2 and ErbB-3. Exp Cell Res.
284:54–65. 2003. View Article : Google Scholar : PubMed/NCBI
|
|
15
|
Franklin MC, Carey KD, Vajdos FF, Leahy
DJ, de Vos AM and Sliwkowski MX: Insights into ErbB signaling from
the structure of the ErbB2-pertuzumab complex. Cancer Cell.
5:317–328. 2004. View Article : Google Scholar : PubMed/NCBI
|
|
16
|
Scheuer W, Friess T, Burtscher H,
Bossenmaier B, Endl J and Hasmann M: Strongly enhanced antitumor
activity of trastuzumab and pertuzumab combination treatment on
HER2-positive human xenograft tumor models. Cancer Res.
69:9330–9336. 2009. View Article : Google Scholar : PubMed/NCBI
|
|
17
|
Fendly BM, Winget M, Hudziak RM, Lipari
MT, Napier MA and Ullrich A: Characterization of murine monoclonal
antibodies reactive to either the human epidermal growth factor
receptor or HER2/neu gene product. Cancer Res. 50:1550–1558.
1990.PubMed/NCBI
|
|
18
|
Agus DB, Gordon MS, Taylor C, Natale RB,
Karlan B, Mendelson DS, Press MF, Allison DE, Sliwkowski MX,
Lieberman G, et al: Phase I clinical study of pertuzumab, a novel
HER dimerization inhibitor, in patients with advanced cancer. J
Clin Oncol. 23:2534–2543. 2005. View Article : Google Scholar : PubMed/NCBI
|
|
19
|
Yamamoto N, Yamada Y, Fujiwara Y, Yamada
K, Fujisaka Y, Shimizu T and Tamura T: Phase I and pharmacokinetic
study of HER2-targeted rhuMAb 2C4 (pertuzumab, RO4368451) in
Japanese patients with solid tumors. Jpn J Clin Oncol. 39:260–266.
2009. View Article : Google Scholar : PubMed/NCBI
|
|
20
|
Baselga J, Gelmon KA, Verma S, Wardley A,
Conte P, Miles D, Bianchi G, Cortes J, McNally VA, Ross GA, et al:
Phase II trial of pertuzumab and trastuzumab in patients with human
epidermal growth factor receptor 2-positive metastatic breast
cancer that progressed during prior trastuzumab therapy. J Clin
Oncol. 28:1138–1144. 2010. View Article : Google Scholar : PubMed/NCBI
|
|
21
|
Swain SM, Kim SB, Cortés J, Ro J,
Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A,
Knott A, et al: Pertuzumab, trastuzumab, and docetaxel for
HER2-positive metastatic breast cancer (CLEOPATRA study): Overall
survival results from a randomised, double-blind,
placebo-controlled, phase 3 study. Lancet Oncol. 14:461–471. 2013.
View Article : Google Scholar : PubMed/NCBI
|
|
22
|
Baselga J, Cortés J, Im SA, Clark E, Ross
G, Kiermaier A and Swain SM: Biomarker analyses in CLEOPATRA: A
phase III, placebo-controlled study of pertuzumab in human
epidermal growth factor receptor 2-positive, first-line metastatic
breast cancer. J Clin Oncol. 32:3753–3761. 2014. View Article : Google Scholar : PubMed/NCBI
|
|
23
|
Swain SM, Im YH, Im SA, Chan V, Miles D,
Knott A, Clark E, Ross G and Baselga J: Safety profile of
pertuzumab with trastuzumab and docetaxel in patients from Asia
with human epidermal growth factor receptor 2-positive metastatic
breast cancer: Results from the phase III trial CLEOPATRA.
Oncologist. 19:693–701. 2014. View Article : Google Scholar : PubMed/NCBI
|
|
24
|
Pharmaceuticals and Medical Devices
Agency: Report on the deliberation results of Parjeta.
2013.https://www.pmda.go.jp/files/000153631.pdfAccessed.
April 2–2015
|
|
25
|
Gianni L, Pienkowski T, Im YH, Roman L,
Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J,
Im SA, et al: Efficacy and safety of neoadjuvant pertuzumab and
trastuzumab in women with locally advanced, inflammatory, or early
HER2-positive breast cancer (NeoSphere): A randomised multicentre,
open-label, phase 2 trial. Lancet Oncol. 13:25–32. 2012. View Article : Google Scholar : PubMed/NCBI
|
|
26
|
Schneeweiss A, Chia S, Hickish T, Harvey
V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, et al:
Pertuzumab plus trastuzumab in combination with standard
neoadjuvant anthracycline-containing and anthracycline-free
chemotherapy regimens in patients with HER2-positive early breast
cancer: A randomized phase II cardiac safety study (TRYPHAENA). Ann
Oncol. 24:2278–2284. 2013. View Article : Google Scholar : PubMed/NCBI
|
|
27
|
simpleClinicalTrials.govA study of trastuzumab
emtansine (T-DM1) plus pertuzumab/pertuzumab placebo versus
trastuzumab [Herceptin] plus a taxane in patients with metastatic
breast cancer (MARIANNE). https://clinicaltrials.gov/ct2/show/NCT01120184Accessed.
April 2–2015
|
|
28
|
F. Hoffmann-La, Roche Ltd. Update on phase
III MARIANNE study in people with previously untreated advanced
HER2-positive breast cancer (media release, Basel, 19 December
2014). http://www.roche.com/media/store/releases/med-cor-2014-12-19.htmAccessed.
April 2–2015
|
|
29
|
simpleClinicalTrials.govA study of pertuzumab in
combination with Herceptin (trastuzumab) and a taxane in first-line
treatment in patients with HER2-positive advanced breast cancer
(PERUSE). https://clinicaltrials.gov/ct2/show/NCT01572038Accessed.
April 2–2015
|
|
30
|
simpleClinicalTrials.govA study of pertuzumab in
combination with Herceptin (trastuzumab) and vinorelbine in first
line in patients with metastatic or locally advanced HER2-positive
breast cancer. https://clinicaltrials.gov/ct2/show/NCT01565083Accessed.
April 2–2015
|
|
31
|
simpleClinicalTrials.govA study of a combination of
trastuzumab and capecitabine with or without pertuzumab in patients
with HER2-positive metastatic breast cancer (PHEREXA). https://clinicaltrials.gov/ct2/show/NCT01026142Accessed.
April 2–2015
|
|
32
|
simpleClinicalTrials.govA study of pertuzumab in
combination with trastuzumab plus an aromatase inhibitor in
patients with hormone receptor-positive, metastatic HER2-positive
breast cancer. https://www.clinicaltrials.gov/ct2/show/NCT01491737Accessed.
April 2–2015
|
|
33
|
Japan Breast Cancer Research Group: A
study of eribulin in combination with trastuzumab and pertuzumab
for advanced or recurrent human epidermal growth factor receptor 2
(HER2)-positive breast cancer (JBCRG-M03). http://www.jbcrg.jp/en/clinicaltrials/detail.php?id=32Accessed.
April 2–2015
|
|
34
|
Japan Pharmaceutical Information Center: A
post-marketing clinical study to evaluate the efficacy and safety
of pertuzumab combined with trastuzumab and docetaxel as first line
treatment in HER2- positive inoperable or recurrent breast cancer.
http://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-132321Accessed.
April 2–2015
|
|
35
|
simpleClinicalTrials.govA study of pertuzumab in
addition to chemotherapy and Herceptin (trastuzumab) as adjuvant
therapy in patients with HER2-positive primary breast cancer.
https://www.clinicaltrials.gov/ct2/show/study/NCT01358877Accessed.
April 2–2015
|
|
36
|
simpleClinicalTrials.govA Study of Kadcyla
(trastuzumab emtansine) plus Perjeta (pertuzumab) following
anthracyclines in comparison with Herceptin (trastuzumab) plus
Perjeta and a taxane following anthracyclines as adjuvant therapy
in patients with operable HER2-positive primary breast cancer.
https://clinicaltrials.gov/ct2/show/study/NCT01966471Accessed.
April 2–2015
|
|
37
|
Verma S, Miles D, Gianni L, Krop IE,
Welslau M, Baselga J, Pegram M, Oh DY, Diéras V, Guardino E, et al:
EMILIA Study Group: Trastuzumab emtansine for HER2-positive
advanced breast cancer. N Engl J Med. 367:1783–1791. 2012.
View Article : Google Scholar : PubMed/NCBI
|
