Group of diseases that tend to mutate the cells in the body resulting into uncontrolled division of cells forming a mass or lump called as tumor. Cancer is generally named after the body part from where the tumor originates. The breast cancer originates in the milk production glands that are present in breast tissues called to be as lobules and also originate in the ducts that are connected to lobules. Cancer that originates in the lobules are known to be lobular carcinoma while which begins in the ducts is ductal carcinoma. According to the report published by ASCO (American Society of Clinical Oncology) in 2014, ductal carcinomas contribute to about 75% of all breast cancers. The breast cancer that spreads beyond the ducts or lobules is known to be infiltrating ductal or invasive carcinoma. For invasive cancer, a hospital laboratory test is carried out, wherein HER2 levels are measured particularly, in a sample of breast tissue obtained from a biopsy or surgery. HER2 is also known to be as ERBB2 which is Erb-B2 receptor tyrosine kinase 2. HER2 or ERBB2, is human epidermal growth factor receptor 2 which plays an important role in view of breast cancer. HER2 or ERBB2 gene is responsible for coding HER2 or ERBB2 proteins which are the receptors on the breast. Three common test employed to test for HER2 levels are chromogenic in situ hybridization (CISH), immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer. In HER2 or ERBB2 receptors in a normal breast maintains growth, division and repairing while in HER2 or ERBB2 positive breast cancer over-expression of HER2 or ERBB2 is seen. In case of HER2 negative breast cancer the levels of HER2 protein is in normal. About 80% of all breast cancers in the U.S are diagnosed as HER2 negative breast cancer, as reported by ASCO (American Society of Clinical Oncology) in a clinical practice guidelines update published for HER2 negative breast cancer in 2014. HER2-negative breast cancer is most common among patients with metastatic breast cancer.
The treatment for HER2 negative breast cancer includes chemotherapy, radiation, surgery and hormonal or endocrine therapy. Hormonal or endocrine therapy is generally an adjunct therapy given to patients after surgery, chemotherapy or radiation therapy. For treatment of breast cancer receptor testing plays an important role for deciding the treatment for the patient. HER2 negative breast cancer can be ER (Estrogen Receptor) positive if it is tested positive for estrogen receptors; PR (Progesterone Receptor) positive if it is tested positive for progesterone receptor; while breast cancer can be TNBC (Triple Negative Breast Cancer) if there is absence of all three receptors i.e. HER2 or ERBB2, estrogen and progesterone. Generally hormonal therapy is employed for HER2 negative breast cancer. Hormonal therapy works on two basic wherein hormonal drugs or medications that brings down the estrogen level in body or the growth and function of breast cells supported estrogen is blocked. Thus, hormonal therapy is helpful only if the breast cancer cells have hormone receptors that can be targeted in the therapy. But in cases such as TNBC (Triple Negative Breast Cancer) wherein the breast cancer cells are negative for estrogen, progesterone as well as for HER2 (human epidermal growth factor receptor 2), the hormonal therapy is of no use for treatment.
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The driver for HER2 negative breast cancer treatment market is the high incidence and growing prevalence of breast cancer in women worldwide. Also there are many drugs in pipeline for the treatment of HER2 negative breast cancer and for treatment of breast cancer in general. While the restraints in HER2 negative breast cancer treatment market is the side effects of treatment such as chemotherapy; there is a threat of reoccurrence of the tumors in majority of treatments; and treatment of cancer requires few or more treatments together which is stressful and expensive for the patient.
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