A Phase 3 Study Assessing Palbociclib and Letrozole With Inavolisib or a Placebo to Treat Advanced Breast Cancer

Full Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus A CDK4/6 Inhibitor and Letrozole in Patients with Endocrine-SensitivePIK3CA- Mutated Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer (WIRB)

Purpose

Researchers are comparing two combination treatments for breast cancer that has metastasized (spread) or is inoperable (cannot be removed surgically). The people in this study have breast cancer that has hormone receptors (HR) but is negative for the HER2 protein.

If you take part in this study, you will be randomly assigned to get one of these treatments:

• Inavolisib, palbociclib, and letrozole
• Placebo (inactive drug), palbociclib, and letrozole

All of these medications are already used to treat breast cancer. They are taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

• Have HR-positive, HER2-negative inoperable or metastatic breast cancer that keeps growing after treatment.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Komal Jhaveri’s office at 646-888-5145.