Trastuzumab (Herzuma) - Breast Cancer and Gastric Cancer Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1

A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Johnston SR, et al. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29. Lancet Oncol. 2013. PMID: 23902874 Clinical Trial. Show more similar articles References Cancer Genome Atlas Network Comprehensive molecular portraits of human breast tumours. Nature. 2012;490:61–70. - - Stemke-Hale K, Gonzalez-Angulo AM, Lluch A. An integrative genomic and proteomic analysis of PIK3CA, PTEN (...) Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial Fulvestrant Plus Capivasertib Versus Placebo After Relapse or Progression on an Aromatase Inhibitor in Metastatic, Oestrogen Receptor-Positive Breast Cancer (FAKTION): A Multicentre, Randomised, Controlled, Phase 2 Trial - PubMed This site needs JavaScript to work properly

[online only] 1 for more details of the literature search). Articles from the search were included if they reported data on outcomes of local therapy (therapeutic or prophylactic mastectomy, nipple-sparing mastectomy, RT) among women with newly diagnosed nonmetastatic or advanced breast cancer and a high- or moderate-penetrance germline mutation. Disease outcomes considered in the studies included in the literature were ipsilateral events, including true recurrences and new primary tumors, survival (...) short to evaluate lifetime risk. CLINICAL QUESTION 2 What is the appropriate surgical management of the index malignancy for women with newly diagnosed nonmetastatic breast cancer who have a selected moderate-penetrance mutation? Recommendation 2.1 For women with newly diagnosed breast cancer who have a mutation in a moderate-penetrance breast cancer gene, mutation status alone should not determine local therapy decisions for the index tumor or CRRM (Type: formal consensus; Evidence quality: low

receptor–positive breast cancer who are candidates for adjuvant endocrine therapy should be offered tamoxifen for an initial duration of five years; those with a contraindication to tamoxifen may be offered a gonadotropin-releasing hormone agonist/antagonist plus aromatase inhibitor. Men who have completed five years of tamoxifen, have tolerated therapy, and still have a high risk of recurrence may be offered an additional five years of therapy. Men with early-stage disease should not be treated (...) with bone-modifying agents to prevent recurrence, but could still receive these agents to prevent or treat osteoporosis. Men with advanced or metastatic disease should be offered endocrine therapy as first-line therapy, except in cases of visceral crisis or rapidly progressive disease. Targeted systemic therapy may be used to treat advanced or metastatic cancer using the same indications and combinations offered to women. Ipsilateral annual mammogram should be offered to men with a history of breast

dose. Adjust boost as follows: No boost in original treatment plan: Add boost 2.5 Gy x 4 Boost in original treatment plan: consider additional 2.5 Gy fraction to boost PTV total 12.5 Gy ** BC, breast cancer; BCT, breast conserving therapy; ER, estrogen receptor; Gy; gray; HER2, human epidermal growth factor receptor 2; HF, hypofractionated; IMN, internal mammary node;LVI, lymphovascular invasion; NAC, neoadjuvant chemotherapy; PTV, planning tumor volume; PMRT, postmastectomy radiation therapy; PNI (...) the increased risk of adverse events. Dose reductions can minimize treatment-related toxicities. CDK4/6 inhibitors as first/second-line treatment offer clinical advantage, but may be delayed if the likelihood of tumor control is high with endocrine therapy alone (first line, no prior endocrine treatment, no visceral disease). 35 Dose reduction of palbociclib does not diminish efficacy. 36,37 High Risk Lesions and Pre-Invasive BC High-risk lesions such as atypical hyperplasia and lobular carcinoma in-situ

), proliferation rate (Ki-67 index), and spread in the lymph nodes, the tumour’s hormone receptor status, and completeness of resection in case of surgery (R0 resection) [13, 14, 17]. Surgical treatment of mammary carcinoma In 2014, suspected breast cancer resulted in 74 224 surgical procedures being performed at 817 German hospitals [9]. The surgical treatment of mammary carcinoma can be generally classified as breast-conserving surgery versus mastectomy. The choice of therapeutic procedure depends (...) - invasive mammary carcinoma and is chosen by about 60–70% of female patients [13]. It takes the form of either tumourectomy, segmentectomy, or quadrantectomy. The goal is complete tumour removal. Breast-conserving therapy with subsequent radiotherapy is equivalent to Extract of rapid report V18-05 Version 1.0 Relationship between volume and quality in breast cancer surgery 13 January 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - 3 - mastectomy in terms of survival figures [19-21

conser- vative surgery is feasible and accurate for staging the axilla. Lobular neoplasia [formerly called lobular carcinoma in situ (LCIS)], unlike DCIS, is considered a non-obligate precursor to invasive cancer. It is regarded as a risk factor for future development of invasive cancer in both breasts [relative risk (RR): 5.4–12] and does not require active treatment. The pleomorphic variant of lobular neoplasia may behave similarly to DCIS and should be treated accordingly, after multidisciplin (...) the individual’s recurrence risk and potentially predict the bene?t of ChT in general [I, A] [19, 126], albeit not for specif- ic cytotoxic agents. Genomic tests are not recommended for patients with: • clinicopathological low-risk tumours (pT1a, pT1b, G1, ER high, pN0); and/or • patients with comorbid health conditions who are not candi- dates for adjuvant ChT; and/or • special types of luminal-like breast cancer such as low-grade encapsulated papillary carcinoma and solid papillary carcin- oma (which should

Risk of breast cancer before and after rheumatoid arthritis, and the impact of hormonal factors Risk of Breast Cancer Before and After Rheumatoid Arthritis, and the Impact of Hormonal Factors - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Welcome to the new PubMed. For legacy PubMed go to . Clipboard, Search History, and several other advanced features are temporarily unavailable. National Institutes of Health U.S (...) Permalink Copy Page navigation Ann Rheum Dis Actions . 2020 Mar 11;annrheumdis-2019-216756. doi: 10.1136/annrheumdis-2019-216756. Online ahead of print. Risk of Breast Cancer Before and After Rheumatoid Arthritis, and the Impact of Hormonal Factors , , , Affiliations Expand Affiliations 1 Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden hjalmar.wadstrom@ki.se. 2 Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet

, as requested by a specialist or consultant physician, for the characterisation of MALM2 gene rearrangement. Maximum one test per lifetime Fee: $340 XXXXX-17 Analysis of tumour tissue from a patient with clinical or laboratory evidence, including morphological features, of mammary analogue secretory carcinoma of the salivary gland, as requested by a specialist or consultant physician, for the characterisation of ETV6-NTRK3 gene rearrangement. Maximum one test per lifetime Fee: $340 XXXXX-18 Analysis (...) or mammary analogue secretory carcinoma (MASC) of salivary glands. Fee: $454 each OR In the assessment of malignant salivary gland tumours, identification of: • MALM2 gene status for the diagnosis of mucoepidermoid carcinoma AND/OR • ETV6-NTRK3 gene status for the diagnosis of analogue secretory carcinoma AND/OR • EWSR1 gene status for the diagnosis of hyalinising clear cell carcinoma. Fee: $454 (for each) OR Identification of TFE3 or TFEB gene rearrangement in the assessment of renal cell carcinoma. Fee

-expression-profiling-tests-for-early-stage-invasive-breast-cancer March 2020 Ontario Health Technology Assessment Series; Vol. 20: No. 10, pp. 1–234, March 2020 3 ABSTRACT Background Breast cancer is a disease in which cells in the breast grow out of control. They often form a tumour that may be seen on an x-ray or felt as a lump. Gene expression profiling (GEP) tests are intended to help predict the risk of metastasis (spread of the cancer to other parts of the body) and to identify people who will most (...) and the experiences, preferences, and values of people with early-stage invasive breast cancer. BACKGROUND Health Condition Breast cancer is a disease in which cells in the breast grow out of control, eventually forming a tumour. Environmental, lifestyle, and genetic factors influence a person’s risk of developing breast cancer. These risk factors may include obesity, physical inactivity, alcohol consumption, age, hormone replacement therapy, dense breasts, genetic mutation, and a personal and/or family history

Similar Breast Cancer Risk in Women Older Than 65 Years Initiating Glargine, Detemir, and NPH Insulins Similar Breast Cancer Risk in Women Older Than 65 Years Initiating Glargine, Detemir, and NPH Insulins - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Welcome to the new PubMed. For legacy PubMed go to . Clipboard, Search History, and several other advanced features are temporarily unavailable. National Institutes (...) to an error Add Cancel Add to My Bibliography My Bibliography Unable to load your delegates due to an error Add Cancel Actions Cite Share Permalink Copy Page navigation Diabetes Care Actions 2020 Feb 19 [Online ahead of print] Similar Breast Cancer Risk in Women Older Than 65 Years Initiating Glargine, Detemir, and NPH Insulins , , , , , , , , , , Affiliations Expand Affiliations 1 Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver

Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221) Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221) - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Welcome to the new PubMed. For legacy PubMed go to . Clipboard (...) collection: Name must be less than 100 characters Choose a collection: Unable to load your collection due to an error Add Cancel Add to My Bibliography My Bibliography Unable to load your delegates due to an error Add Cancel Actions Cite Share Permalink Copy Page navigation J Clin Oncol Actions , 38 (8), 804-814 2020 Mar 10 Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221

Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer: The PAKT Trial The phosphatidylinositol 3-kinase (PI3K)/AKT signaling pathway is frequently activated in triple-negative breast cancer (TNBC). The AKT inhibitor capivasertib has shown preclinical activity in TNBC models, and drug sensitivity has been associated with activation of PI3K or AKT and/or deletions of PTEN. The PAKT trial was designed to evaluate the safety (...) and efficacy of adding capivasertib to paclitaxel as first-line therapy for TNBC.This double-blind, placebo-controlled, randomized phase II trial recruited women with untreated metastatic TNBC. A total of 140 patients were randomly assigned (1:1) to paclitaxel 90 mg/m2 (days 1, 8, 15) with either capivasertib (400 mg twice daily) or placebo (days 2-5, 9-12, 16-19) every 28 days until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Secondary end

CYP2D6 Genotype-Guided Tamoxifen Dosing in Hormone Receptor-Positive Metastatic Breast Cancer (TARGET-1): A Randomized, Open-Label, Phase II Study In patients taking tamoxifen, the CYP2D6 genotype causes different exposure of active metabolite endoxifen. The objective of this randomized, open-label, multicenter, phase II study was to prospectively evaluate whether CYP2D6 genotype-guided tamoxifen dosing in patients with hormone receptor-positive metastatic breast cancer could have an impact (...) in the RD arm (median, 89.2 nM v 51.1 nM; P < .0001) and were also higher compared with wt/wt patients (72.0 nM; P = .045). No significant difference in Z-endoxifen concentrations was observed between patients with disease progression and those who were progression free at 6 months (P = .43).In patients with CYP2D6-variant alleles, increasing tamoxifen dosing did not achieve a higher PFS rate at 6 months. The CYP2D6 genotype solely cannot explain individual variability in the efficacy of tamoxifen.

Risks and Benefits of HRT before and after a Breast Cancer Diagnosis Risks and Benefits of HRT before and after a Breast Cancer Diagnosis | British Menopause Society Search for: Summary consensus statement Risks and Benefits of HRT before and after a Breast Cancer Diagnosis Risks and Benefits of HRT before and after a Breast Cancer Diagnosis 2018-11-28T11:58:36+01:00 Summary In women with a low underlying risk of breast cancer (i.e. most of the population): The benefits of HRT in the short-term (...) (up to 5 years’ use) for symptom relief will exceed potential harm The risk of breast cancer diagnosis associated with HRT is equivalent to, or less that of other lifestyle risk factors for breast cancer Communicating risk in terms of absolute excess risk with framing, minimizes bias and misinterpretation The potential risk of breast cancer diagnosis associated with unopposed or combined HRT should not be discussed in isolation of its other short and long-term benefits and risks In women at high

, MD, USA. PMID: 31859246 DOI: Item in Clipboard CDK4/6 Inhibitor Treatment for Patients With Hormone Receptor-Positive, HER2-negative, Advanced or Metastatic Breast Cancer: A US Food and Drug Administration Pooled Analysis Jennifer J Gao et al. Lancet Oncol . Feb 2020 Show details Lancet Oncol Actions , 21 (2), 250-260 Authors , , , , , , , , , , , , , , , Affiliations 1 Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, US Food and Drug Administration (...) for hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer. We aimed to investigate the benefit of adding CDKIs to endocrine therapy in patients whose tumours might have differing degrees of endocrine sensitivity. Methods: We pooled individual patient data from all phase 3 randomised breast cancer trials of CDKIs plus endocrine therapy submitted to the US Food and Drug Administration before Jan 1, 2019, in support of marketing applications. Our pooled analysis included all randomly

Trastuzumab (Trazimera) - Breast Cancer or Gastric Cancer Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1

Neratinib maleate (Nerlynx) - adjuvant treatment of women with early-stage hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related

Talazoparib (Talzenna) - the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curat Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact

Fam-trastuzumab deruxtecan-nxki (Enhertu) - metastatic breast cancer Drug Approval Package: ENHERTU ENHERTU " /> U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: ENHERTU Company: Daiichi Sankyo, Inc. Application Number: 761139 Approval Date: 12/20/2019 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF) (PDF