Active not recruitingPHASE2INTERVENTIONAL

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

This study is for people aged 70 or older with early-stage breast cancer that's sensitive to hormones (ER+) but not to HER2 (HER2-). Normally, these patients might have chemotherapy followed by hormone therapy. This study wants to see if we can use a drug called palbociclib alongside hormone therapy instead of chemotherapy, or as a chemotherapy alternative, to reduce potential side effects. Researchers will compare patients who receive chemotherapy first, then hormone therapy, with those who get palbociclib and hormone therapy. The main goal is to see how many people in the palbociclib group are still free from their cancer coming back after three years. It's hoped this could offer a gentler, yet effective, treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

366

Start

14 Jun 2019

Estimated completion

30 Sep 2026

Breast Cancer Stage II Breast Cancer Stage III

What is this study about?

When someone is diagnosed with early-stage breast cancer, the goal of treatment after surgery is often to prevent the cancer from returning. For many older patients whose cancer is sensitive to hormones (known as ER+), chemotherapy is a standard step before starting long-term hormone-blocking medication. While chemotherapy can be very effective, it can also cause significant side effects that might be particularly challenging for older individuals.

This study, called a Phase II trial, is investigating a different approach. Researchers are looking at whether a newer drug called palbociclib, when given alongside the usual hormone therapy, can be a good alternative to chemotherapy for older patients (aged 70 and above) with a specific type of early breast cancer. This type of cancer is identified as Stage II or III, ER-positive, and HER2-negative.

The trial aims to find out if this combination of palbociclib and hormone therapy can prevent the cancer from returning as effectively as the traditional approach of chemotherapy followed by hormone therapy. If successful, this could offer a new, potentially less harsh, treatment option for elderly patients, improving their quality of life while maintaining effective cancer control.

Key takeaways

Tests a new approach for older breast cancer patients (age 70+).
Compares palbociclib + hormone therapy to chemotherapy + hormone therapy.
Aims for a potentially gentler alternative to chemotherapy.
For specific Stage II/III, ER+, HER2- early breast cancer.
Participation involves random assignment to one of two treatment groups.
The primary goal is to see if cancer returns after three years.

Who may be eligible?

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.

Quick self-check

Are you 70 years old or older?
Do you have Stage II or III, ER-positive, HER2-negative early breast cancer?
Have you recently had surgery for your breast cancer (within about the last 8 weeks)?
Do your doctors believe you would normally need chemotherapy to prevent your cancer from returning?
Are you generally well enough to manage normal daily activities?
Has your doctor indicated that a very strong chemotherapy treatment might not be suitable for you?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

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.

Potential risks and benefits

Taking part in this study means you might receive a treatment that could be more gentle than standard chemotherapy while still being effective against your cancer. This could potentially lead to fewer or less severe side effects. However, there's always a chance that the new treatment combination might not work as well as the standard one, or it could have different side effects. All possible side effects of both chemotherapy and palbociclib will be thoroughly explained to you, and you'll be carefully monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (73)

Cliniques Universitaires Saint-Luc
Brussels, Belgium
Institut Jules Bordet-Hopital Universitaire ULB
Brussels, Belgium
AZ Maria Middelares
Ghent, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium
Heilig Hartziekenhuis Lier
Lier, Belgium
C.H.U. Sart-Tilman
Liège, Belgium
AZ Nikolaas - Campus SL
Sint-Niklaas, Belgium
AZ Turnhout - Campus Sint Elisabeth
Turnhout, Belgium
Institut Bergonie
Bordeaux, France
CHU-Lyon - Hopital Femme Mere Enfant
Brou, France
Centre Francois Baclesse (CLCC)
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France

+61 more sites — see the official record for the full list.

Common questions

What is palbociclib?

Palbociclib is a type of targeted therapy drug that helps to slow down the growth of cancer cells.

What does 'adjuvant treatment' mean?

Adjuvant treatment is extra therapy given after the main treatment (like surgery) to help reduce the chance of the cancer coming back.

What kind of breast cancer is this study for?

This study is for early-stage breast cancer (Stage II or III) that is hormone-sensitive (ER+) and HER2-negative.

Will I definitely get palbociclib if I join?

You have a two out of three chance of receiving palbociclib plus hormone therapy. The other third will receive standard chemotherapy followed by hormone therapy.

Who is funding this research?

This information isn't provided in the brief summary, but details like this are usually available from the research team if you are considering participating.