Breast cancer therapies are entering a new era as game-changers emerge for each of the major breast cancer patient populations. New market entrants must possess drug profiles and a savvy clinical development program to overcome such barriers to entry as a stringent regulatory environment and the incursion of cost containment within oncology. This TriMark Publications report provides comprehensive information on major and minor shapers of the breast cancer drug treatment landscape. The study includes detailed discussions on the impact of critical factors, such as genericization, patent cliffs, drug shortages, reimbursement, predictive testing and personalized medicine, to help current and contemplative drug sponsors navigate the breast cancer pharmacotherapeutic market. Moreover, this report contains a detailed analysis of each of the seven main modalities of breast cancer therapies, i.e., hormone therapy, surgery, radiation, molecular targeted therapy, chemotherapy, hormone treatment and targeted drug therapy. Additionally, this study examines prescribing trends and the arrival of the first biosimilar agents and electronic records in post-marketing surveillance.

Table of Contents

1. Overview 9
1.1 About This Report 9
1.2 Scope of This Report 9
1.3 Objectives 9
1.4 Methodology 10
1.5 Drugs Covered in This Report 11
1.6 Summary of Major Findings 13
2. About Breast Cancer 16
2.1 Tumorigenesis 16
2.2 Classification of Breast Cancer 17
2.3 Risk Factors of Breast Cancer 17
2.3.1 Gender, Age and Reproductive Status 18
2.3.2 Genetic Mutation and Family History 19
2.3.3 Environmental Factors 19
2.3.4 Breast Density 20
2.4 The Various Options for Treating Breast Cancer 20
2.4.1 Prevention of Breast Cancer 20
2.4.2 Chemoprevention 20
2.4.3 Prophylactic Surgery 21
2.4.4 Radiation Therapy 21
2.4.5 Systemic Therapy 21
2.4.6 Targeted Therapy 21
2.4.7 Chemotherapy 22
2.4.8 Hormone Therapy 22
3. Global and Regional Data on Breast Cancer 23
3.1 Global Breast Cancer Statistics, 2012 23
3.2 Breast Cancer in the U.S. 28
3.2.1 U.S. Breast Cancer Statistics at a Glance 28
3.2.2 Breast Cancer Occurrence in the U.S. 29
3.2.3 Geographic Differences in Breast Cancer Rates in the U.S. 29
3.2.4 Breast Cancer Mortality Rate in the U.S. 31
3.2.5 Breast Cancer in the U.S. by Age 32
3.2.6 Changing Trends in In Situ Breast Cancer 32
3.2.7 Changing Trends in Invasive Breast Cancer in the U.S. 33
3.2.8 Breast Cancer in the U.S. by Tumor Size 34
3.2.9 Breast Cancer by Age and Ethnicity in the U.S. 36
3.2.10 U.S.: Early Detection of Breast Cancer 37
3.2.10.1 Breast Cancer Screening in the U.S. 37
3.3 Breast Cancer in Canada 38
3.4 Breast Cancer Screening, Survival and Mortality in OECD Countries 39
3.5 Breast Cancer in U.K. 43
3.5.1 Female Breast Cancer by Age in U.K. 43
3.6 Breast Cancer in Australia 44
3.7 Breast Cancer in China 45
3.7.1 Treatment Patterns in China for Breast Cancer 46
3.8 Burden of Breast Cancer in India 49
3.9 Overview of Breast Cancer Incidence in Seven Major Markets 50
4. Pharmaceutical Drugs Used in Breast Cancer Treatment 51
4.1 Selected Classes of Chemotherapies 51
4.1.1 Chemotherapies Available as Generics 52
4.1.2 Branded Chemotherapies 54
4.2 Hormone Treatments 56
4.3 Targeted Drug Therapy 58
5. Game Changers for Her2+ Breast Cancer for the Current Decade 64
5.1 Targeted Her2 Therapies in their Prime 64
5.2 About Her2+ Carcinoma 64
5.3 Molecular Targeted Agents 65
5.3.1 Herceptin 66
5.3.1.1 Mechanism of Action of Herceptin 66
5.3.1.2 Drug Profile of Herceptin 68
5.3.1.3 Herceptin Resistance 72
5.3.1.4 Herceptin Product Positioning 73
5.3.1.5 Herceptin in the Adjuvant Setting 74
5.3.1.6 Herceptin Biosimilars in Development 74
5.3.1.7 Herceptin SC Reformulation 75
5.4 Predictive Testing for Her2+ Breast Cancer 75
5.5 New and Emerging Her2 Targeted Options 77
5.5.1 Pertuzumab 78
5.5.2 T-DM: Chemotherapy with Fewer Side Effects to Win the Patients 82
5.6 Roche's Her2 Portfolio and Oncology Pipeline 86
5.7 Data Prediction of Tykerb Utility after Failure of Herceptin Monotherapy 88
5.7.1 ALTTO and NEO-ALTTO: Drive Her2+ Tumors into Adjuvant Setting 94
5.7.2 TEACH Trial 97
5.7.3 Tykerb Product Positioning 98
5.7.4 GSK's Oncology Pipeline 98
5.8 Emerging Diagnostics to Aid Her2 Targeted Drug Selection 99
5.9 The More Distant Future of Her2 Targeted Therapy 99
5.9.1 Afinitor 99
5.9.2 Afatinib 99
5.9.3 Neratinib 100
6. Game Changers for Estrogen Receptor Positive Breast Cancer for Current Decade 101
6.1 About ER+ Breast Cancer 101
6.1.1 Standard of Care for the Treatment of ER+ Breast Cancer 102
6.2 Adjuvant Chemotherapy in ER+ Breast Cancer 103
6.3 Adjuvant Hormone Therapy in ER+ Breast Cancer 104
6.4 Afinitor Expected to be a Game Changer in ER+ Breast Cancer 105
6.4.1 mTOR/PI3k Resistance 110
6.5 Novartis' Oncology Pipeline 110
6.6 Biphosphonates Shown to Reduce Bone Metastases 112
7. Triple Negative Breast Cancer (TNBC) 115
7.1 Avastin 115
7.2 Angiogenesis Drugs in Development 119
7.3 PARP Inhibitors 120
8. Advances in Chemotherapy 124
8.1 Standard of Care for Chemotherapy 124
8.1.1 Physician Preference 127
8.2 New and Emerging Chemotherapies 127
8.3 Using Existing Chemotherapies in Novel Ways 129
8.4 Chemotherapies Reformulations 130
8.5 Chemotherapies and Drug Shortage Crisis 130
8.6 Future Trends: Tailoring Care 131
8.7 Elderly Patients 131
8.8 Adjuvant Chemotherapy in ER+ Breast Cancer 131
8.9 Adjuvant Chemotherapy in Her2+ Breast Cancer 132
9. Biomarkers, Molecular Diagnostics and Personalized Medicine in Breast Cancer Treatment 133
9.1 Overview of Markers and Diagnostics as Game Changers in Breast Cancer Treatment 133
9.2 Personalized Medicine: Applied Biomarkers and Companion Diagnostics 133
9.3 Multigene Diagnostic Tests 137
9.4 Biomarkers: Drug Tolerability and Toxicity 139
9.5 Personalized Medicine and Companion Diagnostic Tests in Breast Cancer 141
9.6 Her2 and Herceptin 143
9.7 Bayer's Advia Centaur Her2 Assay 145
9.8 Epidermal Growth Factor Receptor Companions 145
9.9 Companies Marketing Her2 Assays 146
9.9.1 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673 146
9.10 Biomarkers as Endpoints in Drug Discovery 147
9.11 Risks and Uncertainties of Companion Diagnostics 149
9.12 Biomarkers, Companion Diagnostics and Regulatory Environment 151
10. Drug Development for the Treatment of Breast Cancer 153
10.1 Targeted Drugs of the PI3k/mTOR Pathway 154
10.2 Her2 Targeted Agents 156
10.2.1 Neratinib 156
10.2.2 Afatinib 157
10.3 VEGF Modulators 158
10.4 Biologics 159
10.5 Vaccines 159
10.6 Overview of Safety Profiles of Pipeline Agents 161
11. Regulatory Trends: How Authorities May Change the Game 164
11.1 Introduction to Regulatory Trends 164
11.2 Case Study Avastin: Regulators Look to Overall Survivor Data 165
11.3 Case Study: T-DMI and Unmet Need 167
11.4 Case Study: Halaven and Trial Design 168
11.5 Postmarketing Surveillance 168
11.6 Regulators Look Towards Longer Term Outcomes 169
11.7 Regulatory Trends for Combination Therapies 169
11.8 Austerity Measures 170
11.9 Reimbursement 171
11.10 U.S. Healthcare Reform and its Potential Impact on Regulation 171
11.11 New PDUFA V Recommendations 173
11.12 Generics and Drug Shortages 173
11.13 Biomarker, Companion Diagnostics and the Regulatory Pathway 175
11.13.1 Regulatory Perspectives on Pharmacogenomics and Biomarker Validation 175
11.13.2 Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics 175
11.13.3 Role of Insurance Industry in Driving Adoption of Pharmacogenomics 176
11.13.4 Role of Pharma Industry in Driving Adoption of Pharmacogenomics 176
11.13.5 FDA Guidance Document on Co-Development 176
11.13.6 Role of Diagnostic Industry in Driving the Adoption of Pharmacogenomics 176
11.14 2012 Regulatory Guidance for Biosimilars 177
11.15 Off-Label Use and Good Publication Practices 178
11.16 The Future Regulatory Environment for Oncology 178
12. Breast Cancer Therapies: Market Analysis 180
12.1 Growth in Breast Cancer Drug Market and the New Entrants 180
12.1.1 Market for Her2+ Drugs 181
12.1.2 Global Market for Breast Cancer Hormonal Therapies 182
12.1.3 Declining Revenue for Aromatase Inhibitors 183
12.1.4 Market for Targeted Therapy in Breast Cancer 184
12.1.5 Shortage of Chemotherapy Drugs 185
12.2 Breast Cancer Market in the U.S. 186
12.2.1 Growth in Inpatient Breast Cancer Services in the U.S. 186
12.2.2 Outpatient Breast Cancer Services in the U.S. 187
12.2.3 Chemotherapy Market in the U.S. 188
12.2.4 Number of Chemotherapy Patients with Breast Cancer in the U.S. 189
12.2.5 Number of Breast Cancer Surgeries in the U.S. 190
12.2.6 U.S. Market for Conventional Breast Cancer Treatments 190
12.2.7 U.S. Market for Standard Imaging Procedures in Breast Cancer 191
12.2.8 U.S. Market for Advanced Breast Imaging Procedures 193
Appendix 1: Breast Cancer Drug Therapies: Marketed and Development 195
Appendix 2: A Woman's Guide to Breast Cancer 200
Appendix 2.1: Breast Biopsy 200
Appendix 2.2: Staging of Breast Cancer 201
Appendix 2.3: Treatment Options 203
Appendix 3: Cancer Treatment and Survivorship 208
Appendix 3.1: Female Breast Cancer 210
Appendix 3.1.1: Treatment and Survival After Breast Cancer 211
Appendix 3.1.2: Special Concerns of Breast Cancer Survivors 212
Appendix 3.2: Childhood Cancer 213
Appendix 3.2.1: Treatment and Survival for Childhood Cancer 213
Appendix 3.3: Colon and Rectum Cancer 214
Appendix 3.3.1: Treatment and Survival for Colon and Rectum Cancer Patients 215
Appendix 3.4: Leukemia and Lymphomas 217
Appendix 3.4.1: Treatment and Survival for Leukemia and Lymphoma Patients 218
Appendix 3.5: Lung and Bronchus Cancer 220
Appendix 3.5.1: Treatment and Survival for Lung and Bronchus Cancer Patients 221
Appendix 3.6: Melanoma 222
Appendix 3.6.1: Treatment and Survival for Melanoma Patients 223
Appendix 3.7: Prostate Cancer 224
Appendix 3.7.1: Treatment and Survival Rate for Prostate Cancer Patients 225
Appendix 3.8: Testicular Cancer 227
Appendix 3.8.1: Treatment and Survival for Testicular Cancer Patients 227
Appendix 3.9: Thyroid Cancer 230
Appendix 3.9.1: Treatment and Survival Rate for Thyroid Cancer Patients 230
Appendix 3.10: Urinary Bladder Cancer 231
Appendix 3.10.1: Treatment and Survival Rate for Urinary Bladder Cancer Patients 232
Appendix 3.11: Uterine Corpus 234
Appendix 3.11.1: Treatment and Survival of Uterine Corpus Patients 234
Appendix 4: U.S. Spending on Cancer 249
Appendix 5: Oncology Drugs and Companion Diagnostics 253
Appendix 6: References 258

List of Figures

Figure 3.1: Breast Cancer Burden by Geography, 2009 25
Figure 3.2: Breast Cancer Incidence Worldwide 26
Figure 3.3: Lifetime Risk of Breast Cancer Worldwide 27
Figure 3.4: Breast Cancer Death Rate in the U.S. by Race and Ethnicity, 1975-2007 31
Figure 3.5: Age-Specific Female Breast Cancer Incidence and Mortality Rates in the U.S. 32
Figure 3.6: Incidence Rates of In Situ Breast Cancer by Age in the U.S., 1975-2008 33
Figure 3.7: Incidence Rates of Invasive Breast Cancer by Age, 1975-2008 33
Figure 3.8: Breast Cancer Incidence Rates by Tumor Size (= 2.0 cm) and Race, 1989-2008 34
Figure 3.9: Breast Cancer Rate (Tumor Size = 2.1-5.0 cm) in the U.S., 1989-2008 35
Figure 3.10: Localized Breast Cancer Rates in the U.S. by Race, 1976-2008 35
Figure 3.11: Female Breast Cancer Incidence and Mortality Rates by Race and Ethnicity in the U.S. 37
Figure 3.12: Percent of All Estimated Cancer Cases in Canadian Women, 2012 39
Figure 3.13: Breast Cancer Screening in women Aged 50-69 in OECD Countries, 2000 and 2009 40
Figure 3.14: Breast Cancer Five-Year Relative Survival Rate in OECD Countries, 1997-2009 41
Figure 3.15: Female Breast Cancer Mortality in OECD Countries, 2000 and 2009 42
Figure 3.16: Number of New Cases per Year and AS Rate in U.K., 2009 44
Figure 3.17: Estimated Breast Cancer Incidence in Australia, 2006-2015 45
Figure 3.18: Age-Standardized Incidence and Mortality Rates of the Most Common Cancers in India 50
Figure 5.1: Schematic Representation of Mechanism of Action of Herceptin 67
Figure 5.2: Blocking of Her2 Dimerization by Herceptin 67
Figure 5.3: Design of Herceptin H0648g Pivotal Trial 68
Figure 5.4: Increased Response Rate by the Addition of Xeloda to Herceptin Therapy 69
Figure 5.5: Extended Survival by 4.8 Months in Herceptin plus Xeloda Therapy 69
Figure 5.6: Herceptin's Black Box Warning 71
Figure 5.7: Clinical Benefit of Herceptin Shown in Four Pivotal Trials 74
Figure 5.8: Example of Her2 ICH and FISH 76
Figure 5.9: Her2 Expression via the Inform Dual ISH Assay 77
Figure 5.10: Interception of EGF Pathway at Different Points by Herceptin, Tykerb and Pertuzumab 78
Figure 5.11: CLEOPATRA Trial Design 78
Figure 5.12: CLEOPATRA Study Progression Free Survival 79
Figure 5.13: CLEOPATRA Safety Study 79
Figure 5.14: T-DM1 Study Design 84
Figure 5.15: T-DM1 Results, Phase II Evaluations 84
Figure 5.16: Complimentary Mechanisms of Action of Roche's 3 Her2 Agents 86
Figure 5.17: Roche's HER Targeted Therapy Clinical Development Program 86
Figure 5.18: Roche's Oncology Pipeline, Phase II and Later 87
Figure 5.19: Tykerb/Tyverb: The Oral Her2 Blocking Agent 89
Figure 5.20: Tykerb/Tryverb Works Differently than Herceptin, but on the Same Target 90
Figure 5.21: EGF100151 Study Design 91
Figure 5.22: Efficacy of Tykerb in the EGF100151 Study 92
Figure 5.23: Tykerb Safety and Tolerability: The EGF100151 Study 92
Figure 5.24: ALTTO Study Designs 95
Figure 5.25: NEO-ALTTO Study Design 96
Figure 5.26: Strong Efficacy for the Combination of Herceptin and Tykerb in NEO-ALTTO 96
Figure 5.27: Benefit in Hormone Receptor Negative and -Positive Her2 Tumors 97
Figure 5.28: GSK's Oncology Pipeline Includes Expanded and New Indications for Tykerb 98
Figure 6.1: Response Rates to Endocrine Manipulation in ER+ Patients, Based on Receptor Type 101
Figure 6.2: Adjuvant Chemotherapy in ER+ Breast Cancer 104
Figure 6.3: Novartis' BOLERO Registrational Program for Afinitor in Breast Cancer 106
Figure 6.4: BOLERO-2 Study Design 106
Figure 6.5: BOLERO-2 Progression Free Survival, Local 107
Figure 6.6: BOLERO-2 Progression Free Survival, Central 108
Figure 6.7: BOLERO-2 Progression Free Survival, Subgroups 108
Figure 6.8: BOLERO-2 Overall Survival 109
Figure 6.9: BOLERO-2 Safety 109
Figure 6.10: Intersection of mTOR and Estrogen Receptor Growth Pathways 110
Figure 6.11: Novartis' Oncology Pipeline and pl3k Modulators in Development 111
Figure 6.12: Novartis' Planned Filings 2012 and Later 111
Figure 6.13: Novartis' Candidate PI3k Modulators 112
Figure 8.1: Halavan's EMBRACE Trial: Improved Survival in Heavily Pretreated Patients 127
Figure 8.2: Halaven's EMBRACE Trial: Improved Overall Survival 128
Figure 8.3: Halaven Effective Largely Irrespective of Prior Chemotherapy Experience 128
Figure 8.4: Halaven Safety 129
Figure 8.5: Access and Rationale for Adjuvant Chemotherapy in ER+ Breast Cancer 132
Figure 9.1: Personalized Drug Treatment 135
Figure 9.2: Approaches to Personalized Medicine 135
Figure 9.3: The Oncotype DX Assay Provides an Individualized Recurrence Score Result 137
Figure 9.4: Mammaprint Genes by Biological Function 138
Figure 9.5: Mammaprint Gene Signature Predicts Survival 139
Figure 9.6: ASCO-CAP Guidelines for Her2 Testing in Breast Cancer: Equivocal Results with IHC 144
Figure 9.7: ASCO-CAP Guidelines for Her2 Testing in Breast Cancer: Results by FISH 144
Figure 9.8: Personalized Medicine Drugs in Development 150
Figure 10.1: EGF and Her2 Receptors 157
Figure 10.2: Afatinib PFS Results in NSCCL 158
Figure 11.1: Healthcare Spending in the U.S. and Selected OECD Countries, 1970-2008 173
Figure 12.1: Growth of Breast Cancer Drug Sales in Major Markets, 2011-2018 181
Figure 12.2: Growth of Her2+ Drug Sales, 2011-2018 182
Figure 12.3: Declining Revenue for Branded Hormonal Therapies, 2011-2018 183
Figure 12.4: Declining Revenue for Aromatase Inhibitors, 2011-2018 184
Figure 12.5: The Her2-/Her2+ Drug Sales in the Major Seven Markets, 2011-2018 185
Figure 12.6: U.S. Shortages of Chemotherapy Drugs, 2005-2010 186
Figure 12.7: U.S. Market: Inpatient Breast Cancer Services, 2011-2021 187
Figure 12.8: U.S. Market: Outpatient Breast Cancer Services, 2011-2021 188
Figure 12.9: U.S. Market: Number of Chemotherapy Utilization, 2011-2021 189
Figure 12.10: Number of Chemotherapy Patients with Breast Cancer in the U.S., 2010-2020 189
Figure 12.11: Number of Breast Cancer Surgeries in the U.S., 2010-2020 190
Figure 12.12: U.S. Outpatient Breast Cancer Services Utilization Growth Rate, 2011-2021 191
Figure 12.13: Percent Growth for Standard Imaging Procedures in U.S. for Breast Cancer, 2011-2021 192
Figure 12.14: U.S. Market: Percent Growth fore Advanced Imaging in Breast Cancer, 2011-2021 193
Figure A2.1: Tumor Sizes 202
Figure A3.1: Breast Cancer in the U.S. by Race and Stage at Diagnosis 210
Figure A3.2: Female Breast Cancer Treatment Patterns by Stage 211
Figure A3.3: Five-Year Survival Rates for Breast Cancer Patients by Race and Stage at Diagnosis 212
Figure A3.4: Distribution of Colon and Rectum Cancer by Race and Stage at Diagnosis 214
Figure A3.5: Colon Cancer Treatment Patterns by Stage 215
Figure A3.6: Rectal Cancer Treatment Patterns by Stage 216
Figure A3.7: Five-Year Survival Rates for Colon and Rectal Cancer Patients by Race and Stage at
Diagnosis 216
Figure A3.8: Distribution (%) of Non-Hodgkin Lymphoma Patients by Race and Stage at Diagnosis 217
Figure A3.9: Chemotherapy Use among Leukemia Patients by Age 218
Figure A3.10: Non-Hodgkin Lymphoma Treatment Patterns 219
Figure A3.11: Distribution (%) of Lung and Bronchus Cancer by Race and Stage at Diagnosis 221
Figure A3.12: Non-Small Cell Lung Cancer Treatment Patterns by Stage 221
Figure A3.13: Five-Year Survival Rates for Lung and Bronchus Cancer Patients 222
Figure A3.14: Distribution (%) of Melanoma by Race and Stage 223
Figure A3.15: Five-Year Survival Rates for Melanoma Patients by Race and Stage 224
Figure A3.16: Distribution of Prostate Cancer by Race and Stage 225
Figure A3.17: Prostate Cancer Primary Treatment Patterns by Age 226
Figure A3.18: Five-Year Survival Rates for Prostate Patients by Race and Stage 227
Figure A3.19: Distribution of Testicular Cancer by Race and Stage 228
Figure A3.20: Treatment Patterns for Testicular Cancer Patients 228
Figure A3.21: Treatment Patterns for Non-Seminomatous Testicular Cancer 229
Figure A3.22: Five-Year Survival Rates for Testicular Cancer Patients by Race and Stage 229
Figure A3.23: Distribution of Thyroid Cancer by Race and Stage 230
Figure A3.24: Five-Year Survival Rates for Thyroid Cancer Patients by Race and Stage 231
Figure A3.25: Distribution of Urinary Bladder Cancer by Race and Stage 232
Figure A3.26: Muscle Invasive Bladder Cancer Treatment Patterns 233
Figure A3.27: Five-Year Survival Rates for Urinary Bladder Cancer Patients by Race and Stage 233
Figure A3.28: Distribution of Uterine Corpus Cancer by Race and Stage 234
Figure A3.29: Uterine Cancer Treatment Patterns by Stage 235
Figure A3.30: Five-Year Survival Rates for Uterine Corpus Cancer Patients by Race and Stage 235
Figure A3.31: Domains of Quality of Life 241
Figure A3.32: Observed-to-Expected Ratios for Subsequent Cancers by Site, Sex and Age 20 and Older 244
Figure A3.33: Observed-to-Expected Ratios for Subsequent Cancers by Primary Site 246
Figure A3.34: Unmet Caregiver Needs by Time Since Diagnosis 247
Figure A4.1: Estimates of National Expenditures for Cancer Care in 2010 by Site 249
Figure A4.2: National Expenditure for Cancer Care in 2010 by Site and Phase of Care 250
Figure A4.3: Proportion of National Expenditure for Cancer Care in 2010 by Site and Phase of Care 251
Figure A4.4: Percentage of Medicare Payments in the First Year Following Diagnosis for Cancer Care by Type of Service in 2002 252
Figure A5.1: Oncology Drugs and CDX Launches, 1995-2011 253
Figure A5.2: Major Oncology Firms' R&D Budgets, 2012 254
Figure A5.3: Oncology Pipeline-Drug Development Strategy 255
Figure A5.4: Oncology Drugs in Development and Future Launches 256
Figure A5.5: Launches, Launch Position and Drugs with CDX, 2012-2017 257
Figure A5.6: Past Oncology Launches vs. Forecast, 1997-2016 257

List of Tables

Table 2.1: Factors That Increase the Risk of Breast Cancer in Women 18
Table 2.2: Age-Specific Probabilities of Developing Invasive Breast Cancer 19
Table 3.1: Worldwide Number of New Cancer Cases and Deaths by Leading Cancer Sites, 2008 23
Table 3.2: Number of New Cancer Cases and Deaths by Geography, 2008 25
Table 3.3: Estimated New Female Breast Cancer Cases and Death by Age in the U.S., 2011 29
Table 3.4: Female Breast Cancer Incidence and Mortality Rates by Race, Ethnicity and State 30
Table 3.5: Five-Year Cause Specific Survival Rate by Race/Ethnicity 36
Table 3.6: Mammography Screening Prevalence by Age and Poverty Status in the U.S., 1987-2010 38
Table 3.7: Breast Cancer Incidence Rates per 100,000 Populations in U.K., 2009 43
Table 3.8: Number of Breast Cancer Patients in U.K., 2009-2010 44
Table 3.9: Metastatic Breast Cancer Patients Who Receive Later Lines of Chemotherapy in China 46
Table 3.10: Top-Three Chemotherapy Regimens for Breast Cancer in China 47
Table 3.11: Top-Three Stage IV Hormone Therapies in China 48
Table 3.12: Breast Cancer Drugs Available in China 48
Table 3.13: Utilization of Traditional Chinese Medicine for Breast Cancer 49
Table 3.14: Incident Breast Cancer Cases in Seven Major Markets, 2010-2019 50
Table 4.1: Selected, Partial List of Chemotherapies 51
Table 4.2: Currently Available Drugs for the Treatment of Breast Cancer 61
Table 5.1: Key Points About Herceptin 70
Table 5.2: Incidence of Congestive Heart Failure in Adjuvant Breast Cancer Studies 72
Table 5.3: Incidence of Cardiac Disfunction in Metastatic Breast Cancer Studies 72
Table 5.4: Selected Ongoing Pertuzumab Studies 81
Table 5.5: Key Points about Pertuzumab (Omnitarg) 81
Table 5.6: Key Efficacy Results from Tykerb's EGF100151 Study 91
Table 5.7: Tykerb: Recommendations for Diarrhea Management 93
Table 5.8: Tykerb (Lapatinib): Key Points 94
Table 7.1: Drugs Targeting Angiogenesis 120
Table 8.1: Selected Chemotherapies in Breast Cancer 124
Table 8.2: Currently Available Chemotherapies 125
Table 8.3: Chemotherapies Reformulations 130
Table 9.1: Timeline for Development of Companion Diagnostics 136
Table 9.2: Personalized Medicine at Nexus Point 136
Table 9.3: Percentage of Non-Responders in Various Drug Classes 140
Table 9.4: High-Profile Drug Withdrawals from the Marketplace 140
Table 9.5: Selected List of Personalized Medicine Tests 142
Table 9.6: ASCO-CAP Guidelines for Her2 Testing in Breast Cancer: Interpretation of Results 144
Table 9.7: Potential Benefits of Biomarkers as Companion Diagnostics 148
Table 9.8: Utility of Biomarker as Companion Diagnostics to Drug Development 148
Table 10.1: Selected Drugs and Classes in Development, Agents in Phase II or Later 153
Table 10.2: PI3k/mTOR Targeted Drugs in Development 155
Table 10.3: Breast Cancer Vaccines in Development 160
Table 10.4: Emerging Drugs and Selected Side Effect Profiles 161
Table A2.1: Staging of Breast Cancer 201
Table A3.1: Estimated Number of Cancer Survivors in the U.S. as of January 1, 2012 208
Table A3.2: Estimated Numbers of U.S. Cancer Survivors by Site as of January 1, 2012 209
Table A3.3: Estimated U.S. Cancer Survivors by Sex and Time since Diagnosis as of January 1, 2012 209
Table A3.4: Estimated U.S. Cancer Survivors by Sex and Age as of January 1, 2012 210
Table A5.1: Annual Revenue of Top Oncology Franchises, 2011 254