Adjuvant Breast Cancer
Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:
Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin
*High-risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
Metastatic Breast Cancer
Herceptin is indicated:
Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin
Metastatic Gastric Cancer
Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin
Cardiomyopathy
Infusion Reactions; Pulmonary Toxicity
Embryo-Fetal Toxicity
Cardiomyopathy
Cardiac Monitoring
Infusion Reactions
Embryo-Fetal Toxicity
Pulmonary Toxicity
Exacerbation of Chemotherapy-Induced Neutropenia
Most Common Adverse Reactions
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS.
Adjuvant Breast Cancer
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is indicated for adjuvant treatment of adults with HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab
*High-risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
Metastatic Breast Cancer
HERCEPTIN HYLECTA is indicated in adults:
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab
Cardiomyopathy
Pulmonary Toxicity
Embryo-Fetal Toxicity
Cardiomyopathy
Cardiac Monitoring
Embryo-Fetal Toxicity
Pulmonary Toxicity
Exacerbation of Chemotherapy-Induced Neutropenia
Hypersensitivity and Administration-Related Reactions
Most Common Adverse Reactions
Adjuvant Breast Cancer
Metastatic Breast Cancer (based on intravenous trastuzumab)
You may report side effects to the FDA at 800–FDA–1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1–888–835–2555.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including BOXED WARNINGS.
Herceptin Prescribing Information. Genentech, Inc. February 2021.
Herceptin Prescribing Information. Genentech, Inc. February 2021.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.
FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.
Herceptin HYLECTA Prescribing Information. Genentech, Inc. February 2019.
Herceptin HYLECTA Prescribing Information. Genentech, Inc. February 2019.
Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052122. Accessed June 24, 2019.
Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052122. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin and cyclophosphamide plus paclitaxel with or without trastuzumab in treating women with node-positive breast cancer that overexpresses HER2. NCT00004067 updated January 15, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00004067. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin and cyclophosphamide plus paclitaxel with or without trastuzumab in treating women with node-positive breast cancer that overexpresses HER2. NCT00004067 updated January 15, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00004067. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in treating women with HER2-positive node-positive or high-risk node-negative breast cancer. NCT00005970 updated June 4, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00005970. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in treating women with HER2-positive node-positive or high-risk node-negative breast cancer. NCT00005970 updated June 4, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00005970. Accessed June 24, 2019.
Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; for the Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052306. Accessed June 24, 2019.
Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; for the Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052306. Accessed June 24, 2019.
Slamon D, Eiermann W, Robert N, et al; for the Breast Cancer International Research Group (BCIRG). Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283. At: https://www.nejm.org/doi/full/10.1056/NEJMoa0910383. Accessed June 24, 2019.
Slamon D, Eiermann W, Robert N, et al; for the Breast Cancer International Research Group (BCIRG). Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283. At: https://www.nejm.org/doi/full/10.1056/NEJMoa0910383. Accessed June 24, 2019.
ClinicalTrials.gov. Combination chemotherapy with or without trastuzumab in treating women with breast cancer. NCT00021255 updated November 15, 2016. At: https://clinicaltrials.gov/ct2/show/record/NCT00021255. Accessed June 24, 2019.
ClinicalTrials.gov. Combination chemotherapy with or without trastuzumab in treating women with breast cancer. NCT00021255 updated November 15, 2016. At: https://clinicaltrials.gov/ct2/show/record/NCT00021255. Accessed June 24, 2019.
Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.
Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. At: https://www.nejm.org/doi/full/10.1056/NEJM200103153441101. Accessed June 24, 2019.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. At: https://www.nejm.org/doi/full/10.1056/NEJM200103153441101. Accessed June 24, 2019.
Marty M, Cognetti F, Maraninchi D, et al; for the M77001 Study Group. Randomized Phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: the M77001 Study Group. J Clin Oncol. 2005;23(19):4265-4274. At: https://ascopubs.org/doi/pdf/10.1200/JCO.2005.04.173. Accessed June 24, 2019.
Marty M, Cognetti F, Maraninchi D, et al; for the M77001 Study Group. Randomized Phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: the M77001 Study Group. J Clin Oncol. 2005;23(19):4265-4274. At: https://ascopubs.org/doi/pdf/10.1200/JCO.2005.04.173. Accessed June 24, 2019.
Bang Y-J, Van Cutsem E, Feyereislova A, et al; for the ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687-697. At: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61121-X/fulltext. Accessed June 24, 2019.
Bang Y-J, Van Cutsem E, Feyereislova A, et al; for the ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687-697. At: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61121-X/fulltext. Accessed June 24, 2019.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
Witton CJ, Reeves JR, Going JJ, Cooke TG, Bartlett JMS. Expression of the HER1-4 family of receptor tyrosine kinases in breast cancer. J Pathol. 2003;200(3):290-297. At: https://onlinelibrary.wiley.com/doi/abs/10.1002/path.1370. Accessed June 24, 2019.
Witton CJ, Reeves JR, Going JJ, Cooke TG, Bartlett JMS. Expression of the HER1-4 family of receptor tyrosine kinases in breast cancer. J Pathol. 2003;200(3):290-297. At: https://onlinelibrary.wiley.com/doi/abs/10.1002/path.1370. Accessed June 24, 2019.
Valabrega G, Montemurro F, Aglietta M. Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer. Ann Oncol. 2007;18(6):977-984. At: https://academic.oup.com/annonc/article/18/6/977/241334. Accessed June 24, 2019.
Valabrega G, Montemurro F, Aglietta M. Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer. Ann Oncol. 2007;18(6):977-984. At: https://academic.oup.com/annonc/article/18/6/977/241334. Accessed June 24, 2019.
Molina MA, Codony-Servat J, Albanell J, Rojo F, Arribas J, Baselga J. Trastuzumab (Herceptin), a humanized anti-HER2 receptor monoclonal antibody, inhibits basal and activated HER2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001;61(12):4744-4749. At: http://cancerres.aacrjournals.org/content/61/12/4744.full-text.pdf. Accessed June 24, 2019.
Molina MA, Codony-Servat J, Albanell J, Rojo F, Arribas J, Baselga J. Trastuzumab (Herceptin), a humanized anti-HER2 receptor monoclonal antibody, inhibits basal and activated HER2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001;61(12):4744-4749. At: http://cancerres.aacrjournals.org/content/61/12/4744.full-text.pdf. Accessed June 24, 2019.
MMIT Analysis.
MMIT Analysis.
IQVIA Plantrak Corticosteroid Data.
IQVIA Plantrak Corticosteroid Data.
HLI lives database.
HLI lives database.
The BrandX™ Co-pay Card Program may help lower the out-of-pocket costs for your patients.
The Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. Patients using Medicare, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD), TRICARE or any other federal or state government program (collectively, “Government Programs”) to pay for their Genentech medicine are not eligible. The Program is not valid for Genentech medicines that are eligible to be reimbursed in their entirety by private insurance plans or other programs.
Under the Program, the patient may pay a co-pay. The final amount owed by a patient may be as little as $0 for the Genentech medicine (see Program specific details). The total patient out-of-pocket cost is dependent on the patient’s health insurance plan. The Program assists with the cost of the Genentech medicine only. It does not assist with the cost of other medicines, procedures or office visit fees. After reaching the maximum annual Program benefit amount, the patient will be responsible for all remaining out-of-pocket expenses. The Program benefit amount cannot exceed the patient’s out-of-pocket expenses for the cost associated with the Genentech medicine. The maximum Program benefit will reset every January 1st. The Program is not health insurance or a benefit plan. The patient’s non-governmental insurance is the primary payer. The Program does not obligate the use of any specific medicine or provider. Patients receiving assistance from charitable free medicine programs (such as the Genentech Patient Foundation) or any other charitable organizations for the same expenses covered by the Program are not eligible. The Program benefit cannot be combined with any other rebate, free trial or a similar offer for the Genentech medicine. No party may seek reimbursement for all or any part of the benefit received through the Program.
The Program may be accepted by participating pharmacies, physicians’ offices or hospitals. Once a patient is enrolled, the Program will honor claims with a date of service that precedes the Program enrollment date up to 180 days. Claims must be submitted within 365 days from the date of service unless otherwise indicated. Use of the Program must be consistent with all relevant health insurance requirements. Participating patients, pharmacies, physicians’ offices and hospitals are responsible for reporting the receipt of all Program benefits as required by any insurer or by law. Program benefits may not be sold, purchased, traded or offered for sale.
The patient or their guardian must be 18 years of age or older to receive Program assistance. The Program is only valid in the United States and U.S. Territories, is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. Eligible patients will be automatically re-enrolled in the Program on an annual basis. Eligible patients will be removed from the Program after 3 years of inactivity (e.g., no claims submitted in a 3-year timeframe). Program eligibility and automatic re- enrollment are contingent upon the patient’s ability to meet all requirements set forth by the Program. Healthcare providers may not advertise or otherwise use the Program as a means of promoting their services or Genentech medicines to patients. The Program is intended for the patient. Only the patient using the Program may receive the funds made available through the Program. The Program is not intended for third parties who reduce the amount available to the patient or take a portion for their own purposes. Patients with health plans that redirect Genentech Program assistance intended for patient out-of-pocket costs may be subject to alternate Program benefit structures. Genentech reserves the right to rescind, revoke or amend the Program without notice at any time.
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