Only your doctor can determine your eligibility to participate in this early breast cancer trial. Download the Doctor Discussion Guide and talk to your doctor.
PALLAS is an abbreviation for PALbociclib CoLlaborative Adjuvant Study.
The PALLAS Trial (NCT02513394) is exploring whether palbociclib, a targeted medication taken with adjuvant endocrine therapy, will decrease the chance of breast cancer coming back beyond endocrine therapy alone.
The PALLAS Trial (NCT02513394) is for people who have had a diagnosis of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and are receiving adjuvant endocrine therapy. Adjuvant endocrine therapy is treatment that is given after surgery, chemotherapy, and/or radiotherapy; examples include tamoxifen and/or aromatase inhibitors (eg, anastrozole, letrozole, exemestane).
The Doctor Discussion Guide will help you have a conversation with your doctor.
A person interested in the PALLAS study must meet eligibility criteria to participate in the trial.
Only your doctor and research team can determine your eligibility to participate in this trial. The downloadable Doctor Discussion Guide will help you have a conversation with your doctor to find out if the PALLAS Trial is right for you.
You can also share the trial identifier number for the PALLAS Trial (NCT02513394) with your doctor to start the conversation. Your doctor can get all of the relevant information about the PALLAS Trial by searching with the trial identifier number at clinicaltrials.gov.
By taking part in this clinical trial, you will help clinicians and scientists understand the potential safety and efficacy of a new investigational medicine.
The knowledge gained through your participation in this clinical trial may ultimately benefit many patients like yourself by helping to identify safe and effective medicines for patients with early breast cancer.
Print the Doctor Discussion Guide and talk with your doctor today.
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Palbociclib belongs to a class of medicines called cyclin-dependent kinase (CDK) inhibitors. Palbociclib works to stop certain proteins (CDK4 and CDK6) from sending signals that cause cancer cells to grow and divide. By blocking these proteins, palbociclib may potentially slow the growth of breast cancer in some patients.
Palbociclib is a targeted medication; it is not an endocrine/hormone medication and is not a chemotherapy. Palbociclib is a pill taken once a day. Palbociclib has demonstrated safety and efficacy in people with metastatic (Stage IV) HR+/HER2- breast cancer and is approved by the FDA to be used for metastatic breast cancer. The PALLAS trial is studying palbociclib in an earlier setting.
For more details about the PALLAS Trial, contact:PALLAS_AFT@alliancefoundationtrials.org
The first step in having a conversation with your doctor about the PALLAS Trial is to download the Doctor Discussion Guide.
You can also share the PALLAS Trial identifier number (NCT02513394) with your doctor to start the conversation. Your doctor can get all of the relevant information about the PALLAS Trial by searching with the trial identifier number at clinicaltrials.gov.
If you (or your doctor) have any additional questions about the PALLAS Trial, contact us at: PALLAS_AFT@alliancefoundationtrials.org.
By taking part in this trial, you will help clinicians and scientists understand whether the addition of an investigational new therapy can help prevent or delay breast cancer from coming back longer than the current standards of treatment do.
The knowledge gained through your participation in this clinical trial may ultimately benefit many patients like yourself by helping to identify safe and effective medicines for patients with breast cancer.
A team of doctors, nurses, social workers, and other healthcare professionals will take care of you throughout the trial. They will give you specific instructions for participating in the trial, monitor your health, adjust or stop your treatment if necessary, and collect information about your experience.
If you participate, you will be randomly assigned to 1 of 2 treatment arms.
One trial arm (Group A) will treat patients with palbociclib and standard endocrine adjuvant endocrine therapy for the first 2 years of treatment, followed by endocrine therapy alone for at least another 3 years.
The other trial arm (Group B) will treat patients with standard endocrine adjuvant therapy alone for at least 5 years, which is typical of the length of treatment for HR+/HER2- early breast cancer.
Regardless of whether you are in Group A or B, the PALLAS Trial will last at least 5 years, which is typical of the length of treatment for HR+/HER2- early breast cancer. Participation in this trial will not require extra time on overall therapy.
Your participation in this clinical trial may involve some additional visits and procedures to allow doctors to monitor the safety and efficacy of your treatment.
With all medicines, there is a risk of side effects. These will be fully explained to you by your doctor, as well as how to manage them.
Discuss any questions with your doctor after downloading the Doctor Discussion Guide.
Yes. You can leave this clinical trial at any time. If for any reason you want to leave the PALLAS Trial, you should talk to your healthcare team before stopping or changing any medications.
If you have any additional questions about the PALLAS Trial, contact us.
You are not alone in your fight against breast cancer. There are a lot of resources available within your reach.
Alliance Foundation Trials (AFT): AFT is a research organization that develops and conducts cancer clinical trials, working closely with pharmaceutical partners, research collaborators, and the Alliance for Clinical Trials in Oncology scientific investigators and institutional member network.
Austrian Breast & Colorectal Cancer Study Group (ABCSG): The ABCSG is Austria’s biggest and best established academic research organization that conducts internationally respected clinical trials to investigate breast and colon cancer. More than 25,000 patients have participated in ABCSG trials since 1984.
Breast International Group (BIG): BIG is an international nonprofit organization for academic breast cancer research groups from around the world. BIG facilitates and accelerates breast cancer research at the international level by stimulating cooperation between its 56 member groups and other academic networks and collaborating with, while working independently from, the pharmaceutical industry. Linked to over 3000 hospitals, BIG is the largest international network dedicated solely to breast cancer.
Clinicaltrials.gov: This site is a service of the US National Institutes of Health. It is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
German Breast Group (GBG): GBG is the leading breast cancer study group in Germany, conducting clinical trials in the adjuvant, neoadjuvant, preventative, and palliative settings.
International Clinical Trials Registry Platform (ICTRP): The mission of the World Health Organization (WHO) ICTRP is to ensure that a complete view of research is accessible to all those involved in healthcare decision making. This will improve research transparency and ultimately strengthen the validity and value of the scientific evidence base.
National Surgical Adjuvant Breast and Bowel Project (NSABP): The NSABP Foundation is a not-for-profit academic research organization with a nearly 60-year history of conducting groundbreaking research studies in breast and colorectal cancer. Its goal is to improve outcomes for cancer patients via improved therapeutic and prevention modalities.
PrECOG: PrECOG is a research company that focuses on cancer clinical trials. In conjunction with industry partners, PrECOG develops clinical trials in all areas of oncology.
Adjuvant therapy: Adjuvant cancer therapy is treatment given after surgery, chemotherapy, and radiation therapy to increase the chance of a cure and lower the chance of cancer returning.
Endocrine therapy: This treatment either (1) lowers the amount of estrogen in the body or (2) blocks estrogen from supporting the growth and function of breast cancer cells. It is also called hormonal therapy and is used for patients with hormone receptor-positive (HR+) breast cancer; examples include tamoxifen and/or aromatase inhibitors (eg, anastrozole, letrozole, exemestane).
Hormone receptor-positive (HR+): The hormone receptor is a cell protein that binds to a specific hormone, such as estrogen. HR+ means that the cancer cells receive signals from estrogen that cause the cancer to grow.
Human epidermal growth factor receptor 2 (HER2): HER2 is a growth factor receptor that plays a role in the development of breast cancer. Information about whether HER2 is overexpressed or not is typically stated in the pathology report.