The development of a new therapy investigated for advanced breast cancer treatment from the Revlon/UCLA Women’s Cancer Research Program at UCLA’s Jonsson Comprehensive Cancer Center directed by Dr. Dennis Slamon received designation from U.S. FDA.
The phase two experimental drug preliminary was the result from a study with advanced cancer in patients who were HER2-negative (HER2-) and estrogen-receptor positive (ER+) and who were given the palbociclib (PD 0332991) drug was being developed by Pfizer Inc. This drug was given above of the standard anti-estrogen medication of letrozole showed significant higher progression-free survival compared to patients taking letrozole alone.
Breast cancer statistics
Except for skin cancers, breast cancer is the most common cancer among American women which is the second-leading cause of cancer related death. In 2013, the American Cancer Society estimated that approximately 232,340 new cases will be diagnosed, 64,640 fresh cases of carcinoma, and about 39,620 women will die of the disease.
The incidence of female breast cancer rates has dropped due to the decline in hormone therapy use after menopause. Today, there are more than 2.9 million breast cancer survivors in the U.S.
In the UK, 550,000 people have been diagnosed with breast cancer. Approximately, 50,000 women and 400 men are diagnosed with breast cancer every year, with 20,000 women and 80 men dying every year. The good news is, more and more people are surviving breast cancer than ever before with 80 percent of women still alive five years after diagnosis. Thanks to research advancement, breast screening, early diagnosis, breast cancer awareness, and new treatments.
Experimental drug for advanced breast cancer treatment
As part of the 2012 FDA Safety and Innovation Act, the therapy was created to review the development of advance breast cancer treatment intended alone or in combination with other drugs.
The panel of breast cancer cells growing in culture dishes tested with palbociclib during a preclinical work showed promising activity against ER + cancer cells. This observation was moved to phase one clinical study specifically designed to set out the safety and dosage combination with letrozole, ER + breast cancer generally used drug, according to the study led by Finn and Slamon at UCLA.
The phase two studies were executed in 165 breast cancer with ER + disease patients. The interim date revealed that with palbociclib-letrozole combination, the progression-survival rate was 26.1 months compared with 7.5 months for those who used letrozole alone. Tumor shrinkage for six months and clinical benefits amid patients with significant disease receiving the combination drug was 70 percent compare with 44 percent for letrozole as well.
Pfizer, in collaboration with Finn and his colleagues initiated a double-blind phase three studies to evaluate pabociclib combined with letrozole as post-menopausal patient’s first-time treatment with ER+, HER2, locally advanced or metastatic breast cancer.
By establishing the correct targets for treatment, researchers can move forward with customized oncology with the right breast cancer patient population to move forward with advanced treatment development.
Written by: Janet Grace Ortigas