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FDA Approval Summary: Sunitinib for the Treatment of Progressive Well‐Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

The oncologist (Dayton, Ohio), 2012-08, Vol.17 (8), p.1108-1113

2012

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Event-Free Survival in Patients with Early HER2-Positive Breast Cancer with a Pathological Complete Response after HER2-Targeted Therapy: A Pooled Analysis

Cancers, 2022-10, Vol.14 (20), p.5051

2022

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Approval Summary: Pemetrexed Maintenance Therapy of Advanced/Metastatic Nonsquamous, Non‐Small Cell Lung Cancer (NSCLC)

The oncologist (Dayton, Ohio), 2010-12, Vol.15 (12), p.1352-1358

2010

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Overestimation of the Effect Size in Group Sequential Trials

Clinical cancer research, 2012-09, Vol.18 (18), p.4872-4876

2012

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Pathological Complete Response in Neoadjuvant Treatment of Breast Cancer

Annals of surgical oncology, 2015-05, Vol.22 (5), p.1441-1446

2015

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First FDA approval of neoadjuvant therapy for breast cancer: pertuzumab for the treatment of patients with HER2-positive breast cancer

Clinical cancer research, 2014-11, Vol.20 (21), p.5359-5364

2014

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FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Clinical cancer research, 2015-11, Vol.21 (21), p.4760-4766

2015

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Review of the Efficacy of Individualized Chemotherapy Selected by In Vitro Drug Sensitivity Testing for Patients With Cancer

Journal of clinical oncology, 1999-05, Vol.17 (5), p.1625-1631

1999

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American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes

Journal of clinical oncology, 2014-04, Vol.32 (12), p.1277-1280

2014

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Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group

Journal of clinical oncology, 2017-11, Vol.35 (33), p.3753-3759

2017

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FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

Clinical cancer research, 2014-09, Vol.20 (17), p.4436-4441

2014

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US Food and Drug Administration Approval Overview in Metastatic Breast Cancer

Journal of clinical oncology, 2012-05, Vol.30 (14), p.1705-1711

2012

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evERA Breast Cancer (BC): Phase III study of giredestrant + everolimus vs exemestane + everolimus in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic BC (ER+, HER2– LA/mBC)

Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.TPS1119-TPS1119

2023

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Re-Evaluation of Pathologic Complete Response as a Surrogate for Event-Free and Overall Survival in Human Epidermal Growth Factor Receptor 2-Positive, Early Breast Cancer Treated With Neoadjuvant Therapy Including Anti-Human Epidermal Growth Factor Receptor 2 Therapy

Journal of clinical oncology, 2023-06, Vol.41 (16), p.2988-2997

2023

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Risk-based decision-making in the treatment of HER2-positive early breast cancer: Recommendations based on the current state of knowledge

Cancer treatment reviews, 2021-09, Vol.99, p.102229-102229, Article 102229

2021

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Abstract OT2-04-08: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy (NAC) with atezolizumab or placebo in patients (pts) with triple negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo: NSABP B-59/GBG 96-GeparDouze

Cancer research (Chicago, Ill.), 2020-02, Vol.80 (4_Supplement), p.OT2-04-08-OT2-04-08

2020

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Which patient characteristics drive treatment decisions in elderly patients with early stage hormone receptor–positive breast cancer?

Journal of clinical oncology, 2017-05, Vol.35 (15_suppl), p.538-538

2017

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First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer

Clinical cancer research, 2013-09, Vol.19 (18), p.4911-4916

2013

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NSABP B-59/GBG 96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy (NAC) with atezolizumab or placebo in patients (pts) with triple-negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo

Journal of clinical oncology, 2019-05, Vol.37 (15_suppl), p.TPS605-TPS605

2019

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Abstract P1-18-01: Risk of recurrence and death in patients with early HER2-positive breast cancer who achieve a pathological complete response (pCR) after different types of HER2-targeted therapy: A retrospective exploratory analysis

Cancer research (Chicago, Ill.), 2020-02, Vol.80 (4_Supplement), p.P1-P1-18-01

2020

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NSABP B-59/GBG 96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy (NAC) with atezolizumab or placebo in Patients (pts) with triple negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo

Journal of clinical oncology, 2018-05, Vol.36 (15_suppl), p.TPS603-TPS603

2018

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Neoadjuvant breast cancer therapy and drug development

Clinical advances in hematology & oncology, 2015-11, Vol.13 (11), p.755-761

2015

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Abstract P5-06-02: Pathologic complete response (pCR) and prognosis following neoadjuvant chemotherapy plus anti-HER2 therapy of HER2-positive early breast cancer (EBC)

Cancer research (Chicago, Ill.), 2020-02, Vol.80 (4_Supplement), p.P5-P5-06-02

2020

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FDA Approval Summary: Sunitinib for the Treatment of Progressive Well‐Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

Event-Free Survival in Patients with Early HER2-Positive Breast Cancer with a Pathological Complete Response after HER2-Targeted Therapy: A Pooled Analysis

Approval Summary: Pemetrexed Maintenance Therapy of Advanced/Metastatic Nonsquamous, Non‐Small Cell Lung Cancer (NSCLC)

Overestimation of the Effect Size in Group Sequential Trials

Pathological Complete Response in Neoadjuvant Treatment of Breast Cancer

First FDA approval of neoadjuvant therapy for breast cancer: pertuzumab for the treatment of patients with HER2-positive breast cancer

FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Review of the Efficacy of Individualized Chemotherapy Selected by In Vitro Drug Sensitivity Testing for Patients With Cancer

American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group

FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

US Food and Drug Administration Approval Overview in Metastatic Breast Cancer

Pathologic Complete Response and Individual Patient Prognosis After Neoadjuvant Chemotherapy Plus Anti-Human Epidermal Growth Factor Receptor 2 Therapy of Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer

evERA Breast Cancer (BC): Phase III study of giredestrant + everolimus vs exemestane + everolimus in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic BC (ER+, HER2– LA/mBC)

Re-Evaluation of Pathologic Complete Response as a Surrogate for Event-Free and Overall Survival in Human Epidermal Growth Factor Receptor 2-Positive, Early Breast Cancer Treated With Neoadjuvant Therapy Including Anti-Human Epidermal Growth Factor Receptor 2 Therapy

Risk-based decision-making in the treatment of HER2-positive early breast cancer: Recommendations based on the current state of knowledge

Abstract OT2-04-08: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy (NAC) with atezolizumab or placebo in patients (pts) with triple negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo: NSABP B-59/GBG 96-GeparDouze

Which patient characteristics drive treatment decisions in elderly patients with early stage hormone receptor–positive breast cancer?

First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer

Efficacy, Safety, and Biomarker Analysis of Combined PD-L1 (Atezolizumab) and VEGF (Bevacizumab) Blockade in Advanced Malignant Peritoneal Mesothelioma

NSABP B-59/GBG 96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy (NAC) with atezolizumab or placebo in patients (pts) with triple-negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo

Abstract P1-18-01: Risk of recurrence and death in patients with early HER2-positive breast cancer who achieve a pathological complete response (pCR) after different types of HER2-targeted therapy: A retrospective exploratory analysis

NSABP B-59/GBG 96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy (NAC) with atezolizumab or placebo in Patients (pts) with triple negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo

Neoadjuvant breast cancer therapy and drug development

Abstract P5-06-02: Pathologic complete response (pCR) and prognosis following neoadjuvant chemotherapy plus anti-HER2 therapy of HER2-positive early breast cancer (EBC)

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