Active not recruitingPHASE3INTERVENTIONAL

PALbociclib CoLlaborative Adjuvant Study

The PALLAS study is for people with early breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-). Doctors want to see if taking a drug called palbociclib for two years, in addition to the usual hormone therapy, helps prevent the cancer from coming back or improves treatment results. This is similar to a 'Phase 3' study, meaning it's a big step in researching new treatments. It's an international effort involving many hospitals and patients to get the most reliable answers. The study also aims to understand if palbociclib works better for certain groups of patients based on their cancer's genetic makeup.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alliance Foundation Trials, LLC.

Enrolment target

5,796

Start

01 Aug 2015

Estimated completion

01 Dec 2028

Breast Cancer

Results

Results from this study

Posted April 2022

Results have been published for this study.

Primary outcome

Invasive Disease Free Survival (iDFS)

Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

Full results on the registry

What is this study about?

This research study, called PALLAS, is focused on improving treatment for a specific type of early breast cancer. This is breast cancer that is 'hormone receptor positive' (meaning its growth is driven by hormones) and 'HER2 negative' (meaning it doesn't have too much of a certain protein called HER2). If you have this type of cancer, your doctors will usually recommend hormone therapy after surgery, and sometimes chemotherapy or radiation.

The main goal of the PALLAS study is to find out if adding a new drug called palbociclib to your standard hormone therapy makes a difference. Researchers want to see if combining these treatments leads to better outcomes compared to hormone therapy alone. This could mean a lower chance of the cancer coming back or other improvements in how well you do after treatment.

To figure this out, some patients in the study will receive palbociclib along with their hormone therapy, while others will receive only the hormone therapy. This allows doctors to compare the two approaches and see if palbociclib provides an extra benefit. They also plan to look closely at the cancer cells to see if different types of breast cancer respond better to palbociclib.

Key takeaways

This study evaluates palbociclib alongside standard hormone therapy for early breast cancer.
It's for specific types of early breast cancer that are hormone receptor positive and HER2 negative.
Participation involves taking medication for two years and regular check-ups.
The study aims to see if palbociclib improves long-term outcomes.
You have the right to withdraw from the study at any time.
It's a large, international study (Phase III) to gather strong evidence.

Who may be eligible?

This study is for adults aged 18 or older who have been diagnosed with early breast cancer that is Stage II or Stage III. Your breast cancer must be 'hormone receptor positive' (ER+ and/or PR+) and 'HER2 negative'. You must have already had surgery for your breast cancer.

You can join if you are just starting hormone therapy or have been on it for up to six months. You also need to be able to take oral medication. Before joining, the hospital will check that your blood counts are at a healthy level and that you’ve recovered well from any previous treatments like chemotherapy, radiation, or surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Stage II or Stage III 'hormone receptor positive', 'HER2 negative' breast cancer?
Have you had surgery for your breast cancer?
Are you able to swallow oral medicines?
Have you started hormone therapy recently (within the last 6 months), or are you about to start it?
Have you recovered well from any previous treatments like chemotherapy or radiation?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive palbociclib (if assigned to that group) for two years, alongside your regular hormone therapy. You would have regular check-ups, which include physical exams, blood tests, and discussions with the study team. These visits are to monitor your health, check for any side effects, and see how you are responding to treatment.

The medical team will explain the schedule of visits and tests, which will be more frequent at the beginning and then happen less often over time. Even after the two years of palbociclib treatment would be finished, you would continue to have follow-up appointments to track your long-term health and any return of the cancer. The total duration of follow-up after the treatment phase would be discussed with you.

Potential risks and benefits

Potential benefits of taking part could include gaining access to a new treatment (palbociclib) that might offer better outcomes for your type of breast cancer than standard therapy alone. However, there's no guarantee it will work for you, and it may not improve your condition. Potential risks include side effects from palbociclib, which your doctor will explain in detail. These can vary from person to person. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (437)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of South Alabama Mitchell Cancer Institute
Verified postcode
Mobile, United States
Southern Cancer Center PC - Providence
Verified postcode
Mobile, United States
Katmai Oncology Group
Verified postcode
Anchorage, United States
Providence Alaska Cancer Center
Verified postcode
Anchorage, United States
Mayo Clinic in Arizona
Verified postcode
Phoenix, United States
Kaiser Permanente Anaheim Medical Center
Verified postcode
Anaheim, United States
Kaiser Permanente Baldwin Park Medical Center
Verified postcode
Baldwin Park, United States
Kaiser Permanente Bellflower Medical Center
Verified postcode
Bellflower, United States
Kaiser Permanente Fontana Medical Center
Verified postcode
Fontana, United States
Marin Cancer Care
Verified postcode
Greenbrae, United States
Marin Cancer Center
Verified postcode
Greenbrae, United States
Kaiser Permanente Harbor City Medical Center
Verified postcode
Harbor City, United States

Common questions

What is palbociclib?

Palbociclib is a medicine that works by blocking certain proteins that help cancer cells grow and divide. It's not a chemotherapy but a targeted treatment.

What does 'hormone receptor positive' and 'HER2 negative' mean?

This describes specific features of your breast cancer cells. 'Hormone receptor positive' means hormones can fuel its growth. 'HER2 negative' means it doesn't have an excess of a specific protein called HER2.

Will I definitely get palbociclib if I join?

The study involves two groups, chosen randomly. One group gets palbociclib with hormone therapy, and the other gets hormone therapy alone. You won't know which group you're in.

How long would I take part in the study?

If you receive palbociclib, you'd take it for two years. However, you'll have follow-up appointments for a longer period to monitor your health.

What are the main side effects of palbociclib?

Common side effects can include tiredness and changes in blood counts, which could make you more prone to infections. Your doctor will discuss all potential side effects with you.