Management of Metastatic HER2-Positive Breast Cancer: Where Are We and Where Do We Go From Here?
Invasive breast cancer is the most frequently diagnosed non- dermatologic cancer in women, with an estimated 234,190 new cases diagnosed in 2015.
HER2 status is the most powerful predictive biomarker with which to determine the effectiveness of anti-HER2 therapy.[9] The primary means of patient assessment is through immunohistochemistry to detect HER2 protein expression on cancer cell membranes.
Regimens optimizing survival still require chemotherapy (such as THP); however, for patients who are unable to tolerate chemotherapy or simply wish to avoid it, purely targeted regimens can be considered. Certain patients may harbor breast cancers expressing both hormone receptors and HER2 receptors, allowing the opportunity for treatment with targeted therapies directed toward both signaling pathways. Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information including most serious side effects. 1 (855) PERJETA (737-5382) ?Nurses are available immediately or on-call to answer your questions. The information you receive from the PERJETA Patient Support Line is not meant to replace the advice of your healthcare team. Cancer treatments called HER2-targeted therapies have been developed to target the HER2 receptor. HER2 GlossaryHER2 receptorA type of protein that is found on the surface of cells in everyone. HER2 GlossaryTumorAn abnormal mass or growth of tissue that occurs when cells divide too rapidly, in an uncontrolled way; tumors that are malignant are known as cancer. HER2 GlossaryTargeted therapyA type of medicine that is designed to attack specific cancer cells and can also affect healthy cells. HER2 GlossaryDimerizationThe pairing, or connecting, of receptors on the surface of the cell. HER2 GlossaryChemotherapyA type of medicine that kills cells that grow and divide rapidly; these can include cancer cells or normal cells. HER2 GlossaryHER2 dimerization inhibitor (HDI)An anticancer medicine that works by blocking certain receptors from pairing.
HER2 GlossaryHER2-positiveWhen breast cancer cells have too many HER2 receptors, the disease is called HER2-positive or “HER2+” breast cancer. HER2 GlossaryHormonal therapyHelps fight tumors that thrive on hormones like estrogen or progesterone by acting on hormone receptors on tumor cells or by decreasing the amount of estrogen available to bind these receptors.
HER2 GlossaryPathologistA physician who uses laboratory tests to study body fluids and tissues. HER2 GlossaryLymph nodesSmall, bean-shaped organs that store white blood cells and help remove cell waste, germs, and other harmful substances from the body.


HER2 GlossaryPathological complete responsePathological complete response is achieved when no cancer cells are detected (when a tumor and nearby lymph nodes are tested) from a patient who had medicine before surgery. HER2 GlossaryIntravenousA method of administering a drug by inserting a needle into your vein.
HER2 GlossaryAdjuvant treatmentAdditional treatment for early breast cancer that is given after the main treatment (usually surgery) that may include radiation therapy, chemotherapy, hormonal therapy, or targeted therapy. Not all people have serious side effects; however, side effects with PERJETA therapy are common. PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Infusion-related reactions: PERJETA is a medicine that is delivered into a vein through a needle.
Severe allergic reactions: Some people receiving PERJETA may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. The link you selected will take you away from this site to one that is not owned or controlled by Genentech. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Signaling downstream of HER family activation is dependent on heterodimerization of the HER family member triggered by ligand binding to the extracellular ligand-binding domain (with the exception of HER2, which has no identified ligand and is always in an open conformation that allows dimerization).
A better understanding of HER2 biology has led to the development of powerful targeted therapies, and four drugs are already approved by the US Food and Drug Administration for treatment in the metastatic setting (trastuzumab, pertuzumab, lapatinib, and trastuzumab emtansine). While a score of 0 or 1 is negative and a score of 3 is positive, a score of 2 is considered equivocal and indicates the need for further testing. Multiple agents have been studied in combination with trastuzumab in second-line and subsequent-line settings. The HER2–T-DM1 complex undergoes endocytosis and degradation of the linker, ensuring maximal cytotoxic delivery to the tumor cells while limiting systemic toxicity.
As previously discussed, the MARIANNE study provides the rationale for considering T-DM1 in the first-line setting in patients who cannot be treated with standard chemotherapy.
The results of these tests help your primary care doctor make a diagnosis about your health, identify any medical problems you may have, and monitor your health when you have a chronic illness, such as cancer. Also known as an IV infusion, which means that medicine is slowly given directly into the bloodstream through a vein or port.
You must have a HER2 test to know if your breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as PERJETA.
Phosphorylation of the HER kinase domains (with the exception of HER3, which does not have a kinase domain) initiates a downstream cascade resulting in VEGF transcription and other physiological responses required for carcinogenesis.


Optimizing how these drugs are delivered and in what sequence is an important part of modern management of HER2-positive breast cancer. Fluorescent in situ hybridization (FISH) to assess HER2 gene amplification is the preferred testing method. Although continuation of trastuzumab has not been demonstrated to improve OS prospectively, several studies have demonstrated PFS improvements with its use.
In addition, other approaches have been investigated with only targeted therapy, such as the combination of lapatinib with trastuzumab. Too much HER2 is called “HER2 overexpression” and may result in the cells growing and dividing more quickly. The most common infusion-related reactions when receiving PERJETA, Herceptin, and docetaxel were feeling tired, abnormal or altered taste, allergic reactions, muscle pain, and vomiting.
However, while the prognosis has improved, metastatic disease is still not curable; newer, better drugs are needed. Important questions that need to be addressed include the optimal sequence of anti-HER2 agents, how to incorporate anti-HER2 therapies in later-line settings, the appropriateness of combining anti-HER2 agents with endocrine therapy, and how to achieve lower-grade toxicity over a long-term treatment period.
As a result, and since it does not add significant additional toxicity, it is commonly employed in regimens for patients with HER2-positive disease.[14,15] Regarding pertuzumab, there are no data suggesting that continuation of pertuzumab beyond disease progression provides any benefit. Notably, these studies also demonstrate the very poor PFS that can be expected in patients with ER- and HER-positive metastatic breast cancer treated with endocrine therapy alone. Your use of third-party websites is at your own risk and is subject to the third-party website’s privacy policy and terms and conditions for use of such sites. Furthermore, despite advances in the management of metastatic HER2-positive breast cancer, the response rate in the first-line setting ranges from 50% to 80%, and from only 20% to 40% in the second-line setting, with most patients eventually succumbing to their disease.[4-8] To improve upon the existing novel therapeutics and to develop new ones requires a better understanding of the intrinsic biology of HER2-positive disease and its interaction with extrinsic biological systems, including the immune system.
While the rate of serious toxicity is low, it should be noted that lower-grade toxicities, including fatigue, nausea, diarrhea, and neuropathy, may occur and can potentially affect quality of life. However, T-DM1 was associated with improved health-related quality-of-life measures and fewer high-grade adverse events.
Nevertheless, in patients previously treated with trastuzumab, PFS decreased to 5.3 months. Nevertheless, the combination of anti-HER2 and endocrine therapy may be considered for select patients who are unable or unwilling to receive chemotherapy. A HER2 copy number of 6 or greater is considered positive, and a copy number less than 4 is considered negative.




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