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Pfizer Inc. (PFE-NYSE) reported on Monday that their mid-stage trial for their breast cancer treatment Palbociclib, met the study's primary goal. The trial, referred to as Paloma-1, consisted of post-menopausal patients with locally advanced or newly diagnosed breast cancer that had spread to other parts of the body. Patients taking both palbociclib and letrozole went an average of 26.1 months before tumors worsened. That compared with 7.5 months for those taking letrozole without palbociclib. The 18.6-month difference was considered statistically significant. Detailed data from the trial results is expected to be presented at a scientific meeting in San Diego in April.

Based on initial data from the trial in April 2013, Palbociclib was designated a "breakthrough" drug by the FDA. Drugs that may offer substantial improvement over existing treatments for serious or life-threatening diseases are granted "breakthrough" status from the FDA, which can improve the speed of the drugs approval process.

A secondary goal of the study is to determine whether palbociclib can prolong overall survival. Spokeswoman for Pfizer, Sally Beatty said, because it takes longer periods to follow patients and gauge survival trends, that data is not yet available.

Palbociclib blocks enzymes known as cyclin-dependent kinase (CDKs) 4 and 6, was taken in combination with a standard treatment called letrozole among women who were estrogen receptor positive, meaning tumors grow in response to estrogen and HER2-negative, meaning that the HER2 protein is not causing the cancer. Such patients make up about 60% of advanced breast cancer cases. Letrozole is the chemical name of Femora, a Novartis AG drug that belongs to a class of treatments called aromatase inhibitors that block production of estrogen.

Pfizer said, "We are delighted with the final data." Further discussions of the successful data on progression-free survival are planned, with the U.S. Food and Drug Administration "to determine next steps" for palbociclib.

Side effects from palbociclib show that patients taking the drug combination experienced anemia, fatigue and neutropenia - a decline in white blood cells called neutrophils that can put patients at higher risk of infection.

Two late-stage trials of the drug have already begun in patients with advanced breast cancer - Paloma-2 and Paloma-3. 

As an initial treatment for breast cancer, Paloma-2 will test the same drug combination, palbociclib and letrozole.
 

In women whose breast cancer has progressed after hormonal therapy, Paloma-3 will evaluate palbociclib in combination with another hormone therapy, fulvestrant. Fulvestrant, is sold under the brand name Faslodex by AstraZeneca Plc and is a drug treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy.

Pfizer remains in the forefront of a race for a new standard of care for breast cancer.

Breast cancer killed more than 577,190 women worldwide in 2012, according to the Cancer Treatment Centers of America.

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