US-based drugmaker Pfizer, Alliance Foundation Trials (AFT) and Austrian Breast & Colorectal Cancer Study Group (ABCSG) have launched Phase III trial of Ibrance (palbociclib) for patients with hormone receptor-positive early breast cancer.

The Palbociclib Collaborative Adjuvant Study (PALLAS) will assess whether the addition of Ibrance, developed by Pfizer, to standard therapy will improve disease-free survival and prevent the disease from recurring.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

The study for patients with early-stage breast cancer is being carried out in conjunction with Breast International Group (BIG), German Breast Group (GBG), National Surgical Adjuvant Breast and Bowel Project (NSABP), and PrECOG.

"The Palbociclib Collaborative Adjuvant Study (PALLAS) will assess whether the addition of Ibrance, developed by Pfizer, to standard therapy will improve disease-free survival."

Patients enrolled in the study will have cancers that are hormone receptor-positive (HR+), whose growth is enhanced by the hormone estrogen, but are negative for human epidermal growth factor receptor 2 (HER2-), a different tumour-associated protein.

The PALLAS study is a prospective, two-arm, international, multicenter and randomised trial, which will enrol premenopausal and postmenopausal women, or men with stage two or stage three HR+ / HER2- early breast cancer.

In the trial, patients will be randomised to one of two treatment arms, of which one study arm will treat patients with Ibrance (at a dose of 125mg orally once daily for 21 days followed by seven days off treatment in a 28-day cycle) for two years and standard endocrine adjuvant therapy for at least five years.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The second study arm will treat patients with standard endocrine adjuvant therapy alone for at least five years. Around 4,600 subjects are expected to be enrolled in the trial worldwide.

In February this year, Ibrance received approval from the US Food and Drug Administration (FDA) to treat postmenopausal women with estrogen receptor-positive (ER+) / HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.