What is HR+/HER2+
metastatic breast cancer?
What is the
PATINA Trial?
Are You Eligible? Find a Trial
Facility Near You
What Is
Palbociclib?
FAQs &
Resources
NOW ENROLLING

Patients with metastatic breast cancer that is both
hormone receptor-positive and HER2-positive (HR+/HER2+)

WE ARE NOW RECRUITING PATIENTS FOR THIS CLINICAL TRIAL

  • You may be eligible for the PATINA trial if you have been recently diagnosed with metastatic disease and are beginning, undergoing, or have recently completed the initial chemotherapy regimen for your metastatic disease.
Talk to
your doctor
about enrolling

Download the Doctor Discussion Guide to help
you talk to your doctor about the trial.

Get the doctor Discussion guide

Find a trial facility near you

Talk to your doctor about enrolling

Download the Doctor Discussion Guide to help you talk to your doctor about the trial.

Get the doctor Discussion guide Find a trial
facility near you

What is HR+/HER2+ metastatic breast cancer?

Metastatic breast cancer has spread beyond the breast to other organs in the body. It is also called Stage 4 breast cancer. Metastatic breast cancer cannot currently be cured, but treatment may help keep it under control.

 

What is HR+/HER2+ metastatic breast cancer? (cont'd)

Cancer cells use various receptors and proteins to send signals that cause the cancer to grow. For example:

  • Hormone receptor-positive (HR+) means that hormone receptors are stimulating the cancer to grow. It is standard to take endocrine therapy to inhibit this cause of cancer growth
  • HER2-positive (HER2+) means that another type of receptor (HER2) is stimulating the cancer’s growth. It is standard to give anti-HER2 therapy to block this cause of cancer growth
  • Some breast cancers also rely on proteins called CDK4/6 to transmit growth signals. Palbociclib inhibits the activity of CDK4/6

In HR+/HER2+ breast cancer, all of these signaling mechanisms may play a role in the cancer’s growth and spread.

What is the PATINA trial? (NCT02947685)

The PATINA trial will explore the effect of adding an investigational medicine called palbociclib to standard treatments for patients with HR+/HER2+ metastatic breast cancer.

One half of patients will receive standard treatment plus an investigational medicine called palbociclib. The other half of patients will get standard treatment only.

This is a phase 3 trial. This means it is a large study that will gather rigorous evidence about the study treatments.

Induction therapy

All patients must first receive induction therapy for their metastatic cancer. Induction therapy is taken before the study treatments are started.

Induction therapy will include the following treatments:

  • Standard chemotherapy, with drugs such as a taxane (paclitaxel, docetaxel), or vinorelbine
  • Anti-HER2 therapy (antibodies that have been shown to help stop tumors from growing or to shrink them). Most patients will receive both trastuzumab and pertuzumab. Some may receive only trastuzumab

If you've already begun induction therapy, you may still be eligible to join this study.

The induction therapy will be given through a vein once every 3 or 4 weeks. Patients are expected to complete 6 cycles of induction therapy, but they may receive a minimum of 4 or a maximum of 8 cycles.

Study treatments

If the cancer has not progressed after successful completion of induction therapy, the study treatments will be started, which consist of:

  • Endocrine therapy―either an aromatase inhibitor (an oral medicine that you take every day) or fulvestrant (a medicine that is given once a month by intramuscular injection in the doctor's office). Your doctor will advise you which therapy to take
  • Continuation of anti-HER2 therapy―the same drugs used during induction therapy

Half of the patients will also take an investigational medicine called palbociclib in addition to standard treatment. This drug is taken by mouth, once a day in cycles of 3 weeks on, 1 week off.

You will continue to receive your study treatment throughout the trial, as long as your cancer does not progress (grow or spread to other parts of your body) or until you experience a drug toxicity that cannot be managed, or you decide you no longer wish to participate.

Trial design

Key participant criteria*

  • HR+/HER2+ metastatic (Stage 4) breast cancer
  • No treatment for metastatic disease beyond induction therapy
  • In good physical shape with adequate organ function

*Note: Additional criteria apply and can be found at https://clinicaltrials.gov/ct2/show/NCT02947685.

All patients will first receive 6 cycles of induction therapy


Minimum of 4 cycles, maximum of 8.

Upon successful completion of induction therapy (the cancer has not progressed),
participants will be assigned randomly to Group A or B..


Endocrine therapy +
anti-HER2 therapy +
palbociclib

Endocrine therapy +
anti-HER2 therapy

Primary goal of the study

Determine if the addition of palbociclib delays the disease from progressing (growing or spreading to other parts of your body).

Can I participate in the PATINA trial?

A person interested in the PATINA trial must meet eligibility criteria to participate. Only your doctor and the research team can determine whether you are eligible.

You may download the Doctor Discussion Guide (http://www.patina-trial.com/packaged/assets/packaged/assets/pdfs/PATINA_discussion_guide.pdf) for some tips on discussing the trial with your doctor.

You can also start the conversation by sharing the Clinicaltrials.gov trial identifier number (NCT02947685) with your doctor, or by clicking this link: https://clinicaltrials.gov/ct2/show/NCT02947685.

Only your doctor can determine if you are eligible

Download the Doctor Discussion Guide (http://www.patina-trial.com/packaged/assets/packaged/assets/pdfs/PATINA_discussion_guide.pdf) to help you talk to your doctor about the trial.

Only your doctor can determine if you are eligible

Download the Doctor Discussion Guide to help you talk to your doctor about the trial.

Get the doctor Discussion guide

Why take part in a clinical trial?

By taking part in this clinical trial, you will help doctors and scientists understand the potential safety and efficacy of a new investigational treatment regimen.

The knowledge gained through your participation in this clinical trial may benefit future patients by helping to identify safe and effective medicines for HR+/HER2+ metastatic breast cancer.

Only your doctor can determine if you are eligible

Download the Doctor Discussion Guide to help you talk to your doctor about the trial.

Get the doctor Discussion guide

Find a PATINA trial facility near you

If you don't see a location near you now, please bookmark this page and visit again. We are adding new locations on a regular basis.

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    What is palbociclib?

    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 (hormonal) medication and is not a chemotherapy. Palbociclib is a pill taken once a day in cycles of 3 weeks on, 1 week off.

     

    What is palbociclib? (cont'd)

    Palbociclib is on the market in certain countries for a different type of metastatic breast cancer. This new trial will investigate it for HR+/HER2+ metastatic (Stage 4) breast cancer.

    For more details about the
    PATINA trial, contact uscontact us at PATINA@alliancefoundationtrials.org.

    Frequently asked questions

    How do I talk to my doctor about the PATINA trial?

    The first step is to download the Doctor Discussion Guide (http://www.patina-trial.com/packaged/assets/packaged/assets/pdfs/PATINA_discussion_guide.pdf) to help you talk to your doctor about the trial.

    You can also start the conversation by sharing the trial identifier number (NCT02947685) with your doctor. Your doctor will find all the relevant information by entering this number in the search bar at https://clinicaltrials.gov/ct2/show/NCT02947685.

    If you (or your doctor) have additional questions, contact us. contact us at PATINA@alliancefoundationtrials.org.

    Why take part in a clinical trial?

    By taking part in this clinical trial, you will help doctors and scientists understand the potential safety and efficacy of a new investigational treatment regimen.

    The knowledge gained through your participation in this clinical trial may benefit future patients by helping to identify safe and effective medicines for HR+/HER2+ metastatic breast cancer.

    What will happen if I take part?

    A team of study 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 must first complete induction therapy, as described above. You are expected to complete 6 cycles, with a minimum of 4 and a maximum of 8.

     

    Frequently asked questions (cont'd)

    If your cancer has not progressed after induction therapy, you will be randomly assigned to Group A or Group B.

    One trial arm (Group A) will receive investigational palbociclib plus standard therapy for this type of cancer. Standard therapy will consist of endocrine therapy and anti-HER2 therapy, as described above.

    The other trial arm (Group B) will receive standard therapy without palbociclib.

    This trial does not use a placebo (an inactive pill). Both you and your doctor will know what treatment you are receiving.

    You will continue to receive your treatment as long as your cancer does not progress (grow or spread to other parts of your body), or until you experience a drug toxicity that cannot be managed, or you decide you no longer wish to participate.

    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.

    As 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.

    You can download the Doctor Discussion Guide (http://www.patina-trial.com/packaged/assets/packaged/assets/pdfs/PATINA_discussion_guide.pdf) to help you discuss any questions with your doctor.

    Can I leave this clinical trial after it has begun?

    Yes. You can leave the PATINA trial at any time. If for any reason you want to leave the trial, you should talk to your healthcare team before stopping or changing any medications.

    If you have additional questions about the PATINA trial, contact us. (PATINA_AFT@alliancefoundationtrials.org)

    Breast cancer resources

    You are not alone in your fight against breast cancer. There are a lot of resources available within your reach.

    Alliance Foundation Trials (AFT) (http://www.allianceforclinicaltrialsinoncology.org/): AFT is a research organization in the United States 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.

    Australia & New Zealand Breast Cancer Trials Group (ANZBCTG) (https://www.anzbctg.org): ANZBCTG is the largest independent oncology clinical trials research group in Australia and New Zealand. For almost 40 years it has conducted clinical trials for the treatment, prevention, and cure of breast cancer. Through its education department, ANZBCTG also aims to increase awareness and promote breast cancer research.

    Clinicaltrials.gov (http://www.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.

    Fondazione Michelangelo (http://www.fondazionemichelangelo.org/en/): Fondazione Michelangelo is a scientific organization based in Italy aimed at promoting new research projects in oncology. In 2001, it was officially recognized as a nonprofit organization. In addition to designing and conducting clinical trials, the organization is committed to educational activities that include international conferences and seminars, dedicated meetings, and professional courses in oncology. Some of these events are accredited as CME (Continuing Medical Education).

    German Breast Group (GBG) (http://www.gbg.de/): GBG is the leading breast cancer study group in Germany, conducting clinical trials in the adjuvant, neoadjuvant, preventative, and palliative settings.

    PrECOG (http://www.precogllc.org/): PrECOG is a research company in the United States, formed in 2006 by the ECOG Research and Education Foundation, Inc., that focuses on cancer clinical trials. Through its relationship with ECOG, key opinion leaders and the entire network of ECOG investigators and institutions underpin PrECOG. In conjunction with industry partners, PrECOG develops clinical trials in all areas of oncology.

     

    Breast cancer resources (cont'd)

    SOLTI Breast Cancer Research Group (http://www.gruposolti.org/en): SOLTI is a nonprofit organization based in Spain dedicated to clinical research in breast cancer. Established in 1995, the clinical trials performed by SOLTI are designed to answer questions of major scientific interest and clinical relevance about the different tumor subtypes of breast cancer and its responses to new treatments, as well as to convey proposals for new molecules. SOLTI has a broad network of hospital centers in Spain, Portugal, France, and Italy. It also has more than 200 nationally and internationally acknowledged researchers, plus a large team of professionals for the local and global management of clinical operations.

    Glossary

    Adjuvant therapy: Additional treatment given after the primary treatment for a cancer that is not yet metastatic. This usually means after surgery. Adjuvant therapy lowers the risk that the cancer will come back or spread. It may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

    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, aromatase inhibitors (such as anastrozole, letrozole, exemestane), and fulvestrant.

    Hormone receptor-positive (HR+): The hormone receptor is a protein inside the cancer cell 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 receptor on certain cancer cells. When there is an excessive amount of HER2, the cells may grow more quickly and be more likely to spread to other parts of the body. Cancer cells with this feature are termed HER2-positive (HER2+).

    Induction therapy: In this clinical trial, induction therapy is the initial treatment given after metastatic breast cancer is diagnosed. It will consist of chemotherapy and anti-HER2 therapy. The study drugs will be started after the induction therapy.

     

    Glossay (cont'd)

    Metastatic: A metastatic cancer has spread from the primary site (place where it started) to other places in the body. Metastatic breast cancer cannot currently be cured, but treatment can help control the disease.

    Progression: When a cancer continues to grow or spreads in the body, it is progressing. Progression might be measured by an increase in the number, size, or locations of tumors. It may also be identified by an increase in cancer symptoms.

    Receptor: A protein molecule inside or on the surface of a cell that binds to a specific substance. This causes a specific effect in the cell. For example, a hormone receptor may bind with estrogen, which may signal the cancer cell to grow. Different cancers use different receptors to send growth signals.

    Standard treatment: Commonly used and widely accepted treatments that have been tested and proven to be beneficial. Standard therapy varies depending on the type of cancer.

    COLLABORATORS
    Alliance for Clinical Trials in Oncology Austrian Breast & Colorectal Cancer Study Group ABCSG BIG NSABP NSABP PrECOG