Estrogen Receptor-Positive Breast Cancer Pipeline Analysis, 2016

Estrogen receptor-positive breast cancer is the most common female cancer globally. Cancer that is positive for estrogen-receptor are called estrogen receptor (ER) -positive cancer. It receives signals from estrogen hormone that could promote cell growth. Breast is made up of fatty, connective and lymphatic tissues, and various tiny glands called lobules. In breast cancer, cells grow in uncontrollable manner and they form tumor which can be felt as a lump or can be visible under x-ray. In breast cancer, no symptoms appear when tumor is small, and physical sign such as painless lump appear only when tumor size grow. There are recommended set of guidelines for women to follow for detecting breast cancer at early stage.

The estrogen receptor positive breast cancer pipeline has more than 40 drugs. In pipeline analysis, drugs are analyzed based on route of administration and molecule type. The pipeline is also analyzed on the basis of monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and Preclinical stage.

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Phase III & Filed

Phase III clinical trial known for the comparison of new treatments with the standard treatment in which safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. After the completion of Phase III stage, the company files New Drug Application (NDA) to the regulatory authorities. Novartis AG is developing Alpelisib (also known as BYL-719). The drug candidate is in Phase III stage of development for the treatment of Estrogen receptor positive (ER+) breast cancer. There are 9 drugs for ER+ breast cancer in Phase III clinical stage.

Phase II

Enzalutamide, an under-development drug of Astellas Pharma Inc., is in Phase II stage of development for the treatment of estrogen receptor positive (ER+) breast cancer. The drug candidate acts by inhibiting androgen receptor. Enzalutamide is already marketed under brand name Xtandi for the treatment of patients with metastatic castration-resistant prostate cancer. There are total 16 drugs present in phase II trial of estrogen receptor-positive breast cancer. Phase II clinical trial is the second phase that answer safety, efficacy and dosing of the new intervention. Phase II clinical trial take around 2 years to complete and between 100 – 120 patients participate in the Phase II trial.

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Phase I

CC-223 is under development by Celgene Corporation for the treatment of hormone receptor-positive breast cancer. It is an orally administered, selective inhibitor of mammalian target of rapamycin (mTOR) inhibitor. There are 17 drugs present in Phase I clinical stage. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.

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Preclinical

Preclinical study is also known as animal study. It is done before testing a drug in people to find out the toxicity profile of the drug. Preclinical study is of two types, including in vitro and in vivo.

Pipeline analysis provides description about the key companies which are developing estrogen receptor-positive breast cancer drugs. Some of the key players actively involved in the research and development are Novartis AG, Tesaro, Inc., Bayer AG, F. Hoffmann-La Roche AG, Astellas Pharma, Inc., Celgene Corporation, Takeda Pharmaceutical Company Ltd. and Merck & Co., Inc.

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