Disclosures: The authors have disclosed that they have no financial interests, arrangements, or affiliations with the manufacturers of any products discussed in this article or their competitors.
Correspondence: Saroj Niraula, MD, MSc, University of Manitoba and CancerCare Manitoba, 675 McDermot Avenue, Winnipeg, MB, R3E 0V9, Canada. Email: sniraula@cancercare.mb.ca
JardimDL, SchwaederleM, HongDS, . An appraisal of drug development timelines in the era of precision oncology. Oncotarget 2016;7:53037–53046.2741963210.18632/oncotarget.10588)| false
PrasadV, MailankodyS. Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Intern Med2017;177:1569–1575.
PrasadV, MailankodyS. Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Intern Med 2017;177:1569–1575.10.1001/jamainternmed.2017.3601)| false
RugoHS, OlopadeOI, DeMicheleA, . Adaptive randomization of veliparib-carboplatin treatment in breast cancer. N Engl J Med 2016;375:23–34.10.1056/NEJMoa151374927406347)| false
ChienAJ, TripathyD, AlbainKS, . MK-2206 and standard neoadjuvant chemotherapy improves response in patients with human epidermal growth factor receptor 2-positive and/or hormone receptor-negative breast cancers in the I-SPY 2 trial. J Clin Oncol2020;38:1059–1069.
ChienAJ, TripathyD, AlbainKS, . MK-2206 and standard neoadjuvant chemotherapy improves response in patients with human epidermal growth factor receptor 2-positive and/or hormone receptor-negative breast cancers in the I-SPY 2 trial. J Clin Oncol 2020;38:1059–1069.3203188910.1200/JCO.19.01027)| false
DeMicheleAM, MoulderS, BuxtonM, . Efficacy of T-DM1+pertuzumab over standard therapy for HER2+ breast cancer: results from the neoadjuvant I-SPY 2 trial. Presented at the AACR 107th Annual Meeting 2016; April 16-20, 2016; New Orleans, Louisiana.
DeMicheleAM, MoulderS, BuxtonM, . Efficacy of T-DM1+pertuzumab over standard therapy for HER2+ breast cancer: results from the neoadjuvant I-SPY 2 trial. Presented at the AACR 107th Annual Meeting 2016; April 16-20, 2016; New Orleans, Louisiana.10.1158/1538-7445.AM2016-CT042)| false
NandaR, LiuMC, YauC, . Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: an analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol2020;6:676.
NandaR, LiuMC, YauC, . Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: an analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol 2020;6:676.3205313710.1001/jamaoncol.2019.6650)| false
PusztaiL, HanHS, YauC, . Evaluation of durvalumab in combination with olaparib and paclitaxel in high-risk HER2 negative stage II/III breast cancer: results from the I-SPY 2 trial. Presented at the AACR Annual Meeting; April 27, 2020; virtual.
12.
LoiblS, O’ShaughnessyJ, UntchM, . Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol2018;19:497–509.
LoiblS, O’ShaughnessyJ, UntchM, . Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol 2018;19:497–509.2950136310.1016/S1470-2045(18)30111-6)| false
CortazarP, GeyerCEJr. Pathological complete response in neoadjuvant treatment of breast cancer. Ann Surg Oncol 2015;22:1441–1446.10.1245/s10434-015-4404-825727556)| false
CortazarP, ZhangL, UntchM, . Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet2014;384:164–172.
CortazarP, ZhangL, UntchM, . Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 2014;384:164–172.2452956010.1016/S0140-6736(13)62422-8)| false
GyawaliB, HeySP, KesselheimAS. Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs [published online April 22, 2020]. EClinicalMedicine, doi: https://doi.org/10.1016/j.eclinm.2020.100332journal
GyawaliB, HeySP, KesselheimAS. Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs [published online April 22, 2020]. EClinicalMedicine, doi: https://doi.org/10.1016/j.eclinm.2020.100332journal)| false
GianniL, PienkowskiT, ImYH, . 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 Oncol2012;13:25–32.
GianniL, PienkowskiT, ImYH, . 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 2012;13:25–32.2215389010.1016/S1470-2045(11)70336-9)| false
BaselgaJ, BradburyI, EidtmannH, . Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet2012;379:633–640.
BaselgaJ, BradburyI, EidtmannH, . Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet 2012;379:633–640.10.1016/S0140-6736(11)61847-322257673)| false
von MinckwitzG, ProcterM, de AzambujaE, . Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med 2017;377:122–131.10.1056/NEJMoa1703643)| false
Piccart-GebhartM, HolmesE, BaselgaJ, . Adjuvant lapatinib and trastuzumab for early human epidermal growth factor receptor 2-positive breast cancer: results from the randomized phase III adjuvant lapatinib and/or trastuzumab treatment optimization trial. J Clin Oncol2016;34:1034–1042.
Piccart-GebhartM, HolmesE, BaselgaJ, . Adjuvant lapatinib and trastuzumab for early human epidermal growth factor receptor 2-positive breast cancer: results from the randomized phase III adjuvant lapatinib and/or trastuzumab treatment optimization trial. J Clin Oncol 2016;34:1034–1042.2659874410.1200/JCO.2015.62.1797)| false
NiraulaS, AmirE, Vera-BadilloF, . Risk of incremental toxicities and associated costs of new anticancer drugs: a meta-analysis. J Clin Oncol2014;32:3634–3642.
NiraulaS, AmirE, Vera-BadilloF, . Risk of incremental toxicities and associated costs of new anticancer drugs: a meta-analysis. J Clin Oncol 2014;32:3634–3642.2526775710.1200/JCO.2014.55.8437)| false
DelalogeS, CellaD, YeY, . Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial. Ann Oncol2019;30:567–574.
DelalogeS, CellaD, YeY, . Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial. Ann Oncol 2019;30:567–574.3068970310.1093/annonc/mdz016)| false