Open Enrollment for HR+, HER2- Negative

Clinical Trial Details

• Study Name: ALISCA™-Breast1(BRE437)
• Type: Phase 2 study of alisertib (investigational drug) with endocrine therapy
• Patients: HR+, HER2-negative recurrent or metastatic breast cancer
• Sponsor: Puma Biotechnology, Inc.

About Clinical Trials

Clinical trials are essential for advancing modern medicine. They help researchers understand how safe and effective potential treatments are before they become available to the public. Every medicine, vaccine, and health device approved today was first tested in clinical trials involving volunteers.

Why Participate in a Clinical Trial?

• Contribute to Science: Your participation helps researchers learn more about health conditions and treatments.
• Close Monitoring: While direct benefits are not guaranteed, your health will be closely monitored by the study team.
• Personal Choice: Joining a clinical trial is voluntary. You can leave at any time, for any reason.

Your Safety Comes First

Safety is always the top priority. Before you decide to participate, you’ll receive detailed information about the trial, including potential benefits and risks. Your health will be monitored throughout the study.

What to Expect

Before the Trial

• Pre-Screening: Answer questions about your health and medical history.
• Informed Consent: Review trial details and sign a consent form (not a contract).
• Screening: Additional questions and tests to confirm eligibility.

During the Trial

• Treatment: Receive the study medicine and complete trial activities at the clinic or at home.
• Follow-Up: Short-term or long-term visits to monitor your health after treatment.

After the Trial:

Participants can view a summary of trial results about 12 months after completion by registering at pfizerclinicaltrialalumni.com.

Questions to Ask Before Joining

• What is the purpose of this trial?
• What chance do I have of receiving the study medicine?
• Has this treatment been researched before?
• What are the possible side effects?
• Can I take other medications during the trial?
• What costs will be covered?
• Can I still see my regular doctor?
• Will joining affect future treatment options?

What is a Biopsy?

A biopsy is a procedure where tissue or cell samples are taken from your body for closer examination. There are different types of biopsies. To learn more about the biopsy process for this clinical trial, talk to the study doctor.

Possible Risks or Complications

Depending on the procedure, risks may include:

• Bleeding
• Infection
• Scarring

What is a Biopsy in Clinical Research?

In clinical trials, biopsies are called research biopsies. They are performed the same way as diagnostic biopsies, and the risks are similar.

What Happens to the Biopsy Samples?

After collection, your doctor sends the samples to a laboratory. A pathologist examines them under a microscope to analyze:

• How the tumor responds to the study drug
• How the drug interacts with other chemicals in your body

How Does My Research Biopsy Make a Difference?

Research biopsies may not benefit you directly, but they are vital for clinical research. They help:

• Identify patients who benefit most from the study drug
• Detect those at risk for side effects
• Generate data for more accurate diagnoses
• Guide development of future treatments

Your contribution can help improve care for patients with similar conditions in the future.

Questions?

For more information about the study or biopsies, contact your treating physician or the study physician.

Key Tips for Discussing Clinical Trials with Loved Ones

Enrolling in a clinical trial is a big decision that affects both you and your family. Here are some practical tips:

• Have information ready to share: Prepare a simple summary or highlight key points in the documents you’ve received. You can also use the Information Summary Tool (included in the document) as a guide.
• Right time/right place: Choose a quiet, comfortable setting without distractions. Avoid late evenings when people may be tired.
• Explain the basics: Start by reviewing what the clinical trial is for and what happens during it.

Helpful Questions to Guide the Conversation

• Changes in Daily Life:
  • How might joining this trial impact our daily lives?
  • Do we need to adjust schedules or tasks?
  • What might we need help with?
• Getting Support:
  • Who can help us during the trial?
  • How can we support each other?
• Time and Effort:
  • How much time will it take?
  • Will travel or overnight stays be needed?
• Money Talk:
  • What costs are involved?
  • Are there ways to get help with extra expenses?
• Benefits and Challenges:
  • What good things might happen?
  • What challenges could arise?
• Other Choices:
  • What other options exist?
  • How does this trial compare?
• Deciding Together:
  • How will we make decisions?
  • What’s most important to us?
  • What concerns do we have?
  • What more do we need from the doctor?

Information Summary Tool

A table is provided for you to fill in notes about:

• Purpose of the trial
• Potential benefits
• Treatment details
• Required tests
• Frequency and location of visits
• Side effects
• Duration of the trial
• Other thoughts

Tips for Care Partners

If you’ve researched treatment options and think this clinical trial may be a good choice for your loved one, here are some helpful strategies:

• See if they are willing to talk about a clinical trial:
  • Let them know you’ve learned about a clinical trial that might offer a different treatment option.
    • Ask: “When would be a good time for us to talk about it?”
    • If they’re not ready, consider:
      • Asking what concerns they have
      • Offering to let them read the information on their own
      • Asking if they’d discuss it with their doctor
    • Respect their decision. Ultimately, joining a clinical trial is the patient’s choice.
  • Right time/right place: Choose a private, calm moment. Avoid times when they’re stressed or upset.
  • Show you care: Explain that you researched this because you care about them and want to explore all options.
  • Explain clearly: Keep it simple. Share what the trial is for and why you think it might be worth discussing with their doctor.
  • Listen carefully: Give them time to express feelings. Write down questions for the doctor. Avoid interrupting or correcting.
  • Respect their choice: If they’re not ready, let them know you’ll support whatever decision they make.
  • Offer to help: Offer to gather more details or accompany them to speak with their doctor.
  • Be realistic: Don’t make promises you can’t guarantee.
  • Give time to think: Don’t rush them. Let them process the information.

Remember: The goal is to share information without making them feel stressed or pressured.