Adjuvant Palbociclib in Elderly Patients With Breast Cancer

This study is specifically looking for men and women aged 70 or older who have been diagnosed with early-stage breast cancer (Stage II or III). Your cancer must be hormone-sensitive (ER-positive) but not affected by the HER2 protein (HER2-negative). It’s important that your cancer has been recently removed by surgery and that your doctors believe you would normally need chemotherapy to help prevent the cancer from coming back.

You also need to be generally well and able to carry out your daily activities without too much difficulty. The doctors will also check that your cancer hasn't spread to other parts of your body. Additionally, your doctors must feel that a specific strong chemotherapy combination (one that includes both anthracyclines and taxanes) isn't the best option for you, or is too risky.

So, in short, if you're over 70, have this specific type of early breast cancer that's been recently operated on, and your doctors are considering chemotherapy but feel a very strong chemotherapy might not be ideal, this study might be for you.

If you join this study, you'll be randomly assigned to one of two treatment groups, like flipping a coin, but with two chances out of three for the palbociclib group. One group will receive chemotherapy for several cycles, followed by at least five years of standard hormone therapy. The other group will receive palbociclib for up to two years, alongside at least five years of standard hormone therapy. Both treatments begin after your surgery (within about 9 weeks).

You'll have regular hospital visits for check-ups, blood tests, and to receive your medication. How often these visits are will depend on which treatment group you're in. The total duration of active treatment will vary, but hormone therapy will continue for at least five years in both groups. You'll then be followed up for several years to see how your health is and if the cancer returns.