Perjeta

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Food and Drug Administration (FDA) approved Perjeta® (pertuzumab)* in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy for people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer.1

The combination of Perjeta, trastuzumab and docetaxel chemotherapy was the only regimen that has been shown to significantly improve the time people with previously untreated HER2-positive metastatic breast cancer lived without their disease getting worse (median progression-free survival, or PFS, 18.5 vs. 12.4 months; 6.1 months improvement) compared to trastuzumab and docetaxel chemotherapy

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Perjeta

  1. 1. PERJETA® is a first-line treatment for HER2positive metastatic breast cancer. • PERJETA is an FDA-approved treatment for HER2-positive metastatic breast cancer. It is a targeted therapy used as part of a first-line HER2positive metastatic breast cancer treatment plan, in combination with Herceptin (trastuzumab) and docetaxel (chemotherapy).
  2. 2. PERJETA is referred to as a HER2 dimerization inhibitor (HDI).
  3. 3. PERJETA is referred to as a HER2 dimerization inhibitor (HDI). • Learn more about HDIs.
  4. 4. HER family receptors are activated by ligand-induced dimerization, or receptor pairing.3 Dimerization is a critical step in HER family-mediated signaling, and HER receptors are able to homodimerize or heterodimerize with
  5. 5. What is HER2-positive breast cancer? All cells have HER2 receptors, including healthy cells and cancer cells. In HER2-positive breast cancer, tumor cells have more HER2 receptors than normal. Too much HER2 makes these cancer cells grow and divide too rapidly. NONCANCEROUS CELL
  6. 6. What is HER2-positive breast cancer? All cells have HER2 receptors, including healthy cells and cancer cells. In HER2-positive breast cancer, tumor cells have more HER2 receptors than normal. Too much HER2 makes these cancer cells grow and divide too rapidly. HER2-POSITIVE CANCER CELL Cancer treatments called HER2-targeted therapies have been developed to target the HER2 receptor. PERJETA is one of those HER2-targeted therapies.
  7. 7. PERJETA is a targeted therapy for treating HER2-positive metastatic breast cancer. PERJETA was designed to search for and attack cancer cells with too much HER2 HER2 tells cancer cells to grow by sending signals HER2 works by sending signals that tell cells to grow and divide One way that HER2 can send signals is by pairing with other HER receptors. This process is called dimerization
  8. 8. PERJETA is a targeted therapy for treating HER2-positive metastatic breast cancer. PERJETA works with Herceptin to target HER2 PERJETA and Herceptin both target HER2 but work in different ways PERJETA is thought to block one method of signaling so that certain receptors are unable to pair (dimerization) with HER2 Together, PERJETA and Herceptin are thought to create a stronger blockade against HER2 signals, helping to slow down cancer cell growth HER2 signaling could inhibit the growth of tumors.
  9. 9. PERJETA is proven to help control cancer growth Adding PERJETA to Herceptin and docetaxel (chemotherapy) increased the time people lived without their cancer growing or spreading by an average of 50%, compared with people who took Herceptin and docetaxel (chemotherapy) alone
  10. 10. ERJETA helped people live longer On average, people who were given PERJETA, Herceptin, and docetaxel (chemotherapy) lived significantly longer than people given only Herceptin and docetaxel (chemotherapy) PERJETA is proven to shrink tumors 80% of people taking the PERJETA combination had their tumors shrink, compared to 69% of people taking Herceptin and docetaxel (chemotherapy) alonePeople who had their tumors shrink maintained this response, on average, for 62% longer on the PERJETA combination compared with people taking only Herceptin and docetaxel (chemotherapy) (20.2 months vs 12.5 months) PERJETA is taken together with Herceptin, another HER2 therapy PERJETA is a targeted therapy used as part of a first-line HER2-positive metastatic breast cancer treatment plan. This treatment plan includes Herceptin and docetaxel, a type of chemotherapy. PERJETA and Herceptin both target HER2 but are believed to work in complementary ways. The combination may increase death of cancer cells.
  11. 11. THE BREAST
  12. 12. I. Introduction/General Information A. Embryologically: belong to integument B. Functionally: part of reproductive system 1. Respond to sexual stimulation 2. Feed babies
  13. 13. Breast, continued … C. Modified apocrine sweat glands - apex of cell becomes part of secretion and breaks off D. Present in males and females
  14. 14. II. Anatomy A. Position and Attachment 1. Lateral aspect of pectoral region 2. 3. 4. 5. Located between ribs 3 and 6/7 Extend form sternum to axilla Surrounded by superficial fascia Rest on deep fascia
  15. 15. Breast Anatomy
  16. 16. Position & attachment, continued …. 6. Fixed to skin & underlying fascia by fibrous C.T. bands a. Cooper’s (Suspensory) Ligaments b. Ligaments may retract when breast tumors are present
  17. 17. Cooper’s Suspensory Ligaments
  18. 18. Position & attachment, continued … 6. Left breast is usually slightly larger 7. Base is circular, either flattened or concave 8. Separated from pectoralis major muscle by fascia, retromammary space
  19. 19. Retromammary Space Retromammary Space
  20. 20. Anatomy, continued … B. Structure 1. Outer surface convex, skin covered 2. Nipple: a. At fourth intercostal space b. Small conical/cylindrical prominence below center
  21. 21. Nipple location 4th intercostal space
  22. 22. Structure, continued … c. Surrounded by areola: pigmented ring of skin d. Thin skinned region lacking hair, sweat glands e. Contains areolar glands
  23. 23. Structure, continued … 3. Areola: contains dark pigment that intensifies with pregnancy a. Circular and radial smooth muscle fibers b. Cause nipple erection
  24. 24. Areola
  25. 25. Structure, continued … 4. Each breast consists of ~ 20 lobes of secretory tissue a. Each lobe has one lactiferous duct b. Lobes (and ducts) arranged radially c. Embedded in connective tissue & adipose of superficial fascia d. Lobes composed of lobules e. Lobules comprise alveoli
  26. 26. Lobes and Lobules
  27. 27. Structure, continued … 5. Excretory (lactiferous) ducts converge toward areola a. Form ampullae (collection sites of lactiferous sinuses) b. Ducts become contracted at base of nipple
  28. 28. Excretory (lactiferous) ducts
  29. 29. Structure, continued … 6. Secretory epithelium a. Changes with hormonal signals b. Onset of menstruation c. Pregnancy (glands begin to enlarge at 2nd month) d. After birth, 1st secretion is colostrom (contain antibodies)
  30. 30. Structure, continued … 7. “Tail of Spence” = axillary tail a. prolongation of upper, outer quadrant in axillary direction b. Passes under axillary fascia c. May be mistaken for axillary lymph nodes
  31. 31. “Tail of Spence” Axillary Tail
  32. 32. Structure, continued … 8. Fatty Tissue: surrounds surface, fills spaces between lobes a. Determines form & size of breast b. No fatty deposit under nipple & areola
  33. 33. Breast: Fatty Tissue
  34. 34. Structure, continued … C. Vessels & nerves 1. Arteries: derived from thoracic branches of three pairs of arteries a. Axillary arteries 1) continuous with subclavian a. 2) gives rise to external mammary ( = lateral thoracic) artery
  35. 35. Vessels & Nerves, continued … b. Internal mammary (thoracic) arteries 1) first descending branch of subclavian artery 2) supply intercostal spaces & breast 3) used for coronary bypass surgery c. Intercostal arteries: 1) numerous branches from internal & external mammary arteries 2) supply intercostal spaces & breast
  36. 36. Arterial Supply to the Breast Subclavian a. Axillary a. External mammary (thoracic) a. Internal mammary (thoracic) a.
  37. 37. Vessels & Nerves, continued … 2. Veins: a. form a ring around the base of the venosus”) nipple (“circulus b. Large veins pass from circulus venosus to circumference of mammary gland, then to c. External mammary v to axillary v or d. Internal mammary v to subclavian v
  38. 38. Veins draining the Breast Subclavian vein External mammary vein
  39. 39. Breast Anatomy, con’t… 3. Innervation: derived from: a. anterior & lateral cutaneous nerves of thorax b. spinal segments T3 – T6
  40. 40. Structure, continued … 4. Lymphatics: clinically significant! a. Glandular lymphatics drain into anterior axillary (pectoral) nodes  central axillary nodes  apical nodes  deep cervical nodes  subclavicular (subclavian) nodes b. Medial quadrants drain into parasternal nodes
  41. 41. Lymph Nodes of the Breast Subclavian nodes Axillary nodes Lateral pectoral nodes Parasternal nodes
  42. 42. Lymphatics, continued … c. Superficial regions of skin, areola, nipples: -form large channels & drain into pectoral nodes d. NOTE: axillary nodes also drain lymph from arm
  43. 43. Lymph Nodes and Lymph Drainage Axillary Nodes
  44. 44. Routes of Metastasis • From medial lymphatics to parasternal nodes – Then to mediastinal nodes • Across the sternum in lymphatics to opposite side via cross-mammary pathways – Then to contralateral breast • From subdiaphragmatic lymphatics to nodes in abdomen – Then to liver, ovaries, peritoneum
  45. 45. Major Routes of Metastasis Channels to Contralateral Breast Axillary Lymph Channels Subdiaphragmatic Lymph Channels
  46. 46. Structure, continued … D. Anomalies 1. Inverted nipple: congenital or due to cancer 2. Ectopic nipple: a. “polythelia” or “hyperthelia” b. additional nipples along milk line 3. Amastia 4. Micromastia
  47. 47. Anomalies, continued … 5. Macromastia 6. Gynecomastia a. breast development of male in areolar region b. noted in males who smoke marijuana at puberty
  48. 48. III. Diseases of the Breast A. Most are readily detectable B. Etiology unknown, influencing factors 1. Sex 2. Heredity
  49. 49. Diseases of the breast, continued … 3. Endocrine influence a. Menstruation – tenderness from fluid engorgement b. Post-menopause 1) decrease of fibro-cystic disease 2) increase in cancer c. Pregnancy
  50. 50. Diseases of the Breast, continued … C. General symptoms & signs 1. Nipple discharge a. always significant if not pregnant. b. May be due to benign pituitary tumor. 2. Local pain, tenderness 3. Duration of lesion 4. Size, rate of growth
  51. 51. Symptoms & Signs, continued … 5. Retraction sign: “dimpling” involving skin, nipple or areola 6. Mobility of mass a. Benign = movable 1) not attached 2) not invasive b. Malignant = attached 1)May grow into bone
  52. 52. Symptoms & Signs, continued … 7. Consistency of mass a. Cysts = fluctuant; compressible b. Fibroadenoma = rubbery c. Carcinoma = firm, hard (like gravel) 8. Axillary area lymph node enlargement
  53. 53. D. Benign breast conditions 1. Infection = usually during or after lactation a. Recurrent, subareolar abscess b. TB of the breast 2. Trauma = contusion 3. Hypertrophy = seen in either sex at adolescence a. Gynecomastia = in males
  54. 54. Hypertrophy, continued … b. Other causes 1) testicular or pituitary tumor 2) cirrhosis 3) hypogonadism = not enough testosterone 4) estrogen administration for prostate cancer
  55. 55. Breast Cancer
  56. 56. Breast cancer originates in breast tissue and arises from the ductal tissue of the breast and, less commonly, the lobulartissue. There are several forms of breast cancer based, in part, on cellular and genetic characteristics,
  57. 57. Types of Breast Cancer
  58. 58. HER2-Positive Overabundance of the HER2 protein classifies the breast cancer as HER2positive and causes breast cancer cells to multiply, spread more rapidly, and survive longer than other breast cancers
  59. 59. Ductal Carcinoma in situ (DCIS) Ductal cancer cells Carcinoma refers to any cancer that begins in the skin or other tissues that cover internal organs 63 Illustration © Mary K. Bryson Normal ductal cell
  60. 60. Hormone Receptor-Positive Breast cancer cells that express hormone receptors for estrogen (ER) and/or progesterone (PR) are dependent on the signaling of those receptors
  61. 61. Invasive Ductal Carcinoma (IDC – 80% of breast cancer) Ductal cancer cells breaking through the wall • The cancer has spread to the surrounding tissues 65 Illustration © Mary K. Bryson
  62. 62. 67 Illustration © Mary K. Bryson Range of Ductal Carcinoma in situ
  63. 63. Invasive Lobular Carcinoma (ILC) Lobular cancer cells breaking through the wall 68 Illustration © Mary K. Bryson
  64. 64. Cancer Can also Invade Lymph or Blood Vessels Cancer cells invade lymph duct Cancer cells invade blood vessel 69 Illustration © Mary K. Bryson
  65. 65. Mammography • Use a low-dose x-ray system to examine breasts • Digital mammography replaces x-ray film by solid-state detectors that convert x-rays into electrical signals. These signals are used to produce images that can be displayed on a computer screen (similar to digital cameras) • Mammography can show changes in the breast up to two years before a physician can feel them 72
  66. 66. Computer-Aided Diagnosis • Mammography allows for efficient diagnosis of breast cancers at an earlier stage • Radiologists misdiagnose 10-30% of the malignant cases • Of the cases sent for surgical biopsy, only 10-20% are actually malignant CAD systems can assist radiologists to Reduce these problems National Cancer Institute 73
  67. 67. What Mammograms Show Two of the most important mammographic indicators of breat cancers – Masses – Microcalcifications: Tiny flecks of calcium – like grains of salt – in the soft tissue of the breast that can sometimes indicate an early cancer. 74
  68. 68. Detection of Malignant Masses Malignant masses have a more spiculated appearance benign malignant 75
  69. 69. Mammogram – Difficult Case • Heterogeneously dense breast • Cancer can be difficult to detect with this type of breast tissue • The fibroglandular tissue (white areas) may hide the tumor • The breasts of younger women contain more glands and ligaments resulting in dense breast tissue 76
  70. 70. Mammogram – Easier Case • With age, breast tissue becomes fattier and has fewer glands • Cancer is relatively easy to detect in this type of breast tissue 77
  71. 71. Different Views Side-to-Side MRI - Cancer can have a unique appearance – many small irregular white areas that turned out to be cancer (used for diagnosis) Top-to-Bottom 78
  72. 72. Benign Conditions, continued 4. Tumors & cysts a. Fibroadenoma = most common benign breast tumor
  73. 73. Tumors and Cysts, con’t… b. Breast Cyst 1. Benign 2. May be aspirated if large
  74. 74. Benign conditions, continued … c. Fibrocystic breast changes 1) 20%+ of remenopausal women 2) discomfort, cysts 3) treatment rarely required 4) More likely to not detect a developing cancer
  75. 75. Tumors & cysts, continued …. d. Intraductal papilloma - may produce “chocolate” or bloody discharge from nipple e. Lipoma: common - fatty tumors
  76. 76. Carcinoma of the breast 1. Most common malignant tumor among women 2. 1/8 of women will develop breast cancer a. 1/6 in Orange County b. 1/5 in San Francisco 3. Generally no discomfort
  77. 77. Progression to Breast Cancer
  78. 78. Carcinoma of breast, continued … 4. Physical signs: a. b. c. d. e. Slowly growing, painless mass May demonstrate retracted nipple May be bleeding from nipple May be distorted areola, or breast contour Skin dimpling in more advanced stages with retraction of Cooper’s ligaments
  79. 79. Physical signs, continued … f. Attachment of mass g. Edema of skin 1)with “orange skin” appearance (peau d’orange) 2) due to blocked lymphatics h. Enlarged axillary or deep cervical lymph nodes
  80. 80. Breast Cancer, con’t… 5. Common sites for metastasis a. Lungs & pleura b. Skeleton system (skull, vertebral column, pelvis) c. Liver 6. Atypical carcinomas a. Inflammatory carcinoma (hormonal, chemotherapy) b. Paget’s disease of the breast pagget's disease
  81. 81. Scalar Field • A scalar field is a n-dimensional space with a scalar value attached to each point in the space (e.g., a gray-scale image) 89
  82. 82. Scalar Field and Gradient • A scalar field is a n-dimensional space with a scalar value attached to each point in the space (e.g., a gray-scale image) • The derivative of a scalar field results in a vector field called the gradient – i.e., the gradient is a vector field • which points in the direction of the greatest rate of increase of the scalar field, and • whose magnitude is the greatest rate of change 90 Black representing Higher values
  83. 83. Gradient The derivative of a scalar field results in a vector field called the gradient – i.e., the gradient is a vector field • which points in the direction of the greatest rate of increase of the scalar field, and • whose magnitude is the greatest rate of change 91 Black representing Higher values
  84. 84. Cartesian Gradient  g (P ) For an image function I(P) where P is a pixel, the Cartesian gradient at P is: I ( P) 92 I ( P) y I ( P) x tan Magnitude: Orientation: arctan P x I ( P) y g ( P) ( P) (P) I ( P) y I ( P) x m( P) I ( P) x 2 I ( P) y 2 I ( P) y I ( P) x
  85. 85. Radial Gradient • The radial gradient vector has the same magnitude as the Cartesian gradient vector, but • the orientation is given as: r ( P) 93 ( P) ( P) Radial gradient r(P)  g (P ) (P) P (P)
  86. 86. Feature: Spiculation [Huo et al.] • Extract the mass using a region-growing technique • The maximum gradient and its angle relative to the radial direction are computed • Calculate the full-width at half-maximum (FWHM) from the cumulative gradient orientation histogram 94
  87. 87. Feature: Spiculation [Chan et al.] • Determine the outline of the segmented mass • Obtain the rubber-bandstraightening-transformed image – The spicules become approximately aligned in a similar direction • The rectangular region can then be subjected to texture analysis 95
  88. 88. Breast Calcifications • Calcifications show up as white spots on a mammogram • Round well-defined, larger calcifications (left column) are more likely benign • Tight cluster of tiny, irregularly shaped calcifications (right column) may indicate cancer 96
  89. 89. Calcification Features • The morphology of individual calcification, e.g., shape, area, and brightness • The heterogeneity of individual features characterized by the mean, the standard deviation, and the maximum value for each feature. • Cluster features such as total area, compactness 97
  90. 90. Database Approach to Computer-Aided Diagnosis Content-based image retrieval techniques can provide radiologists “visual aids” to increase confidence in their diagnosis • The database consists of a large number of images with verified pathology results • Diagnosis is done by submitting the suspected mass region as a query to retrieve similar cases from the database 98
  91. 91. A Mammography CAD System [Giger et al.] Probability of malignancy Similar images of known diagnosis Indicates the unknown lesion relative to all lesions in the database 99
  92. 92. DESCRIPTION PERJETA® (Pertuzumab)is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic, gentamicin. Gentamicin is not detectable in the final product. Pertuzumab has an approximate molecular weight of 148 kDa. PERJETA is a sterile, clear to slightly opalescent, colorless to pale brown liquid for intravenous infusion. Each single use vial contains 420 mg of pertuzumab at a concentration of 30 mg/mL in 20 mM L-histidine acetate (pH 6.0), 120 mM sucrose and 0.02% polysorbate 20. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  93. 93. Mechanism of Action PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  94. 94. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  95. 95. Pharmacokinetics PERJETA® Pertuzumab demonstrated linear pharmacokinetics at a dose range of 2 – 25 mg/kg. Based on a population PK analysis that included 481 patients, the median clearance (CL) of pertuzumab was 0.24 L/day and the median half-life was 18 days. With an initial dose of 840 mg followed by a maintenance dose of 420 mg every three weeks thereafter, the steady-state concentration of pertuzumab was reached after the first maintenance dose. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  96. 96. INDICATIONS AND USAGE 1.1 Metastatic Breast Cancer (MBC) PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior antiHER2 therapy or chemotherapy for metastatic disease. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  97. 97. INDICATIONS AND USAGE 1.2 Neoadjuvant Treatment of Breast Cancer PERJETA is indicated for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall surviva PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  98. 98. DOSAGE AND ADMINISTRATION The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes. When administered with PERJETA, the recommended initial dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  99. 99. DOSAGE AND ADMINISTRATION Metastatic Breast Cancer (MBC) When administered with PERJETA, the recommended initial dose of docetaxel is 75 mg/m2 administered as an intravenous infusion. The dose may be escalated to 100 mg/m2 administered every 3 weeks if the initial dose is well tolerated. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  100. 100. DOSAGE AND ADMINISTRATION Neoadjuvant Treatment of Breast Cancer PERJETA should be administered every 3 weeks for 3 to 6 cycles as part of one of the following treatment regimens for early breast cancer [see Clinical Studies (14.2)]:  Four preoperative cycles of PERJETA in combination with trastuzumab and docetaxel followed by 3 postoperative cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) as given in Study 2  Three preoperative cycles of FEC alone followed by 3 preoperative cycles of PERJETA in combination with docetaxel and trastuzumab as given in Study 3  preoperative cycles of PERJETA in combination with docetaxel, carboplatin, and Six trastuzumab (TCH) (escalation of docetaxel above 75 mg/m2 is not recommended) as given in Study 3 Following surgery, patients should continue to receive trastuzumab to complete 1 year of treatment. There is insufficient evidence to recommend continued use of PERJETA for greater than 6 cycles for early breast cancer. There is insufficient evidence to recommend concomitant administration of an anthracycline with PERJETA, and there are no safety data to support sequential use of doxorubicin with PERJETA. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  101. 101. DOSAGE AND ADMINISTRATION Dose Modification For delayed or missed doses, if the time between two sequential infusions is less than 6 weeks, the 420 mg dose of PERJETA should be administered. Do not wait until the next planned dose. If the time between two sequential infusions is 6 weeks or more, the initial dose of 840 mg PERJETA should be re-administered as a 60-minute intravenous infusion followed every 3 weeks thereafter by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes. PERJETA should be discontinued if trastuzumab treatment is discontinued. Dose reductions are not recommended for PERJETA. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  102. 102. Preparation for Administration Administer as an intravenous infusion only. Do not administer as an intravenous push or bolus. Do not mix PERJETA with other drugs. Preparation Prepare the solution for infusion, using aseptic technique, as follows: 1. Parenteral drug products should be inspected visually for particulates and discoloration prior to administration. 2. Withdraw the appropriate volume of PERJETA solution from the vial(s). 3. Dilute into a 250 mL 0.9% sodium chloride PVC or non-PVC polyolefin infusion bag. 4. Mix diluted solution by gentle inversion. Do not shake. 5. Administer immediately once prepared. 6. If the diluted infusion solution is not used immediately, it can be stored at 2oC to 8oC for up to 24 hours. 7. Dilute with 0.9% Sodium Chloride injection only. Do not use dextrose (5%) solution. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  103. 103. DOSAGE FORMS AND STRENGTHS PERJETA (pertuzumab) 420 mg/14 mL (30 mg/mL) in a single-use vial CONTRAINDICATIONS PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients. PERJETA® is a first-line treatment for HER2-positive metastatic breast cancer.
  104. 104. HER2 Testing Detection of HER2 protein overexpression is necessary for selection of patients appropriate for PERJETA therapy because these are the only patients studied and for whom benefit has been shown [see Indications and Usage (1) and Clinical Studies (14)]. Patients with breast cancer were required to have evidence of HER2 overexpression defined as 3+ IHC or FISH amplification ratio  2.0 in the clinical studies. Only limited data were available for patients,whose breast cancer was positive by FISH, but did not demonstrate protein overexpression by IHC.
  105. 105. HER2 Testing Assessment of HER2 status should be performed by laboratories using FDAapproved tests with demonstrated proficiency in the specific technology being utilized. Improper assay performance, including use of sub-optimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
  106. 106. ADVERSE REACTIONS Metastatic Breast Cancer 1. The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. Neoadjuvant Treatment of Breast Cancer 1. The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia. 2. The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia. 3. The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.

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