Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer

Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up

(2021) Martine Piccart et al.   JOURNAL OF CLINICAL ONCOLOGY

Pathological response and survival with neoadjuvant therapy in melanoma: a pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC)

(2021) Alexander M. Menzies et al.   NATURE MEDICINE

Palbociclib for Residual High-Risk Invasive HR-Positive and HER2-Negative Early Breast Cancer—The Penelope-B Trial

(2021) Sibylle Loibl et al.   JOURNAL OF CLINICAL ONCOLOGY

Durvalumab improves long-term outcome in TNBC: results from the phase II randomized GeparNUEVO study investigating neodjuvant durvalumab in addition to an anthracycline/taxane based neoadjuvant chemotherapy in early triple-negative breast cancer (TNBC).

(2021) Sibylle Loibl et al.   JOURNAL OF CLINICAL ONCOLOGY

Should regulatory authorities approve drugs based on surrogate endpoints?

(2021) Jeanne Lenzer et al.   BMJ-British Medical Journal

Raising the bar for using surrogate endpoints in drug regulation and health technology assessment

(2021) Dalia Dawoud et al.   BMJ-British Medical Journal

Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer

(2021) W. Fraser Symmans et al.   JAMA Oncology

Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021

(2021) H.J. Burstein et al.   ANNALS OF ONCOLOGY

Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer: a multicentre pooled analysis of 5161 patients

(2021) Christina Yau et al.   LANCET ONCOLOGY

Evaluation of pathological complete response as surrogate endpoint in neoadjuvant randomised clinical trials of early stage breast cancer: systematic review and meta-analysis

(2021) Fabio Conforti et al.   BMJ-British Medical Journal

Combining tumour response and progression free survival as surrogate endpoints for overall survival in advanced colorectal cancer

(2020) E.G. Elia et al.   Cancer Epidemiology

Pembrolizumab for Early Triple-Negative Breast Cancer

(2020) Peter Schmid et al.   NEW ENGLAND JOURNAL OF MEDICINE

Systemic Therapy for Estrogen Receptor–Positive, HER2-Negative Breast Cancer

(2020) Harold J. Burstein   NEW ENGLAND JOURNAL OF MEDICINE

Association of Circulating Tumor DNA With Disease-Free Survival in Breast Cancer

(2020) Carolyn Cullinane et al.   JAMA Network Open

Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival

(2020) M.J.M. Magbanua et al.   ANNALS OF ONCOLOGY

Residual Disease after Neoadjuvant Therapy — Developing Drugs for High-Risk Early Breast Cancer

(2019) Tatiana M. Prowell et al.   NEW ENGLAND JOURNAL OF MEDICINE

NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69–GeparSepto

(2019) Michael Untch et al.   JOURNAL OF CLINICAL ONCOLOGY

Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study

(2019) Sara A. Hurvitz et al.   JOURNAL OF CLINICAL ONCOLOGY

Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer

(2019) Jeanne Tie et al.   JAMA Oncology

Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer

(2018) Gunter von Minckwitz et al.   NEW ENGLAND JOURNAL OF MEDICINE

20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years

(2017) Hongchao Pan et al.   NEW ENGLAND JOURNAL OF MEDICINE

Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy

(2017) Norikazu Masuda et al.   NEW ENGLAND JOURNAL OF MEDICINE

Perils of the Pathologic Complete Response

(2016) Brent S. Rose et al.   JOURNAL OF CLINICAL ONCOLOGY

Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process

(2015) Sylwia Bujkiewicz et al.   STATISTICS IN MEDICINE

Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44–GeparQuinto)†

(2014) G. von Minckwitz et al.   ANNALS OF ONCOLOGY

Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis

(2014) Patricia Cortazar et al.   LANCET

Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint

(2014) Matthew D Hellmann et al.   LANCET ONCOLOGY

Response-Guided Neoadjuvant Chemotherapy for Breast Cancer

(2013) Gunter von Minckwitz et al.   JOURNAL OF CLINICAL ONCOLOGY

Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

(2012) Tatiana M. Prowell et al.   NEW ENGLAND JOURNAL OF MEDICINE

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

(2011) Luca Gianni et al.   LANCET ONCOLOGY