Explore a Clinical Trial for Metastatic Breast Cancer

If you or a loved one has HR+/HER2- locally advanced or metastatic breast cancer whose tumor has a mutation in the PIK3CA gene, consider the ReDiscover-2 Study.

About the ReDiscover-2 Study

The ReDiscover-2 Study is a Phase 3 clinical trial evaluating an investigational study drug in participants living with HR+/HER2- locally advanced or metastatic breast cancer whose tumor has a mutation in the PIK3CA gene.

HR+ (or hormone receptor–positive) means the cancer cells have receptors for estrogen or progesterone, which can promote cancer growth. HER2- (or human epidermal growth factor receptor 2–negative) means the cancer cells do not have high levels of the HER2 protein, which can drive cancer growth.

The goal of this trial is to learn more about the safety and effectiveness of the study drug in comparison to a standard approved treatment. This trial does not include a placebo.

Find a participating site

Who Can Participate?

We are enrolling approximately 540 individuals globally.

To participate in this clinical trial, you must:

  • Be 18 years of age or older (any gender)
  • Have a diagnosis of locally advanced or metastatic HR+/HER2- breast cancer with recurrence or progression
    • This means the cancer must have spread to other areas of the body. Typically, this is stage III or IV
  • Have a tumor with at least one PIK3CA gene mutation
  • Have received certain prior treatment for metastatic breast cancer, including a CDK4/6 inhibitor and endocrine therapy
  • NOT have received certain prior treatment for metastatic breast cancer, including:
    • CDK2 or selective CDK4 inhibitors or any investigational therapies targeting cyclin dependent kinases
    • PI3K, AKT, or mTOR inhibitors, or any agent whose mechanism of action is to inhibit the PI3K/AKT/mTOR pathway
    • Immunotherapy
    • Antibody drug conjugates
    • The study doctor will go over past treatment options with you
  • NOT have metaplastic or inflammatory breast cancer

Additional requirements will apply. The study team will discuss these with you.

About the Investigational Study Drug

There are three study drugs involved in this clinical trial:

RLY-2608 is the new investigational study drug being tested in this trial. It is an oral capsule designed to block the effects of malfunctioning PI3Kα proteins associated with the mutated PIK3CA gene, which can cause cancer growth.

  • RLY-2608 is being evaluated in an ongoing clinical trial in combination with fulvestrant, and has shown encouraging initial results delaying progression in people with metastatic breast cancer.

Fulvestrant is an approved treatment that may be given alongside other treatments (like TRUQAP™ [capivasertib]) for HR+/HER2- metastatic breast cancer. It is an injection that blocks the effects of the hormone estrogen, which can contribute to cancer growth.

Learn more here

TRUQAP™ (capivasertib) is a metastatic breast cancer treatment approved in certain countries that may be given alongside fulvestrant. It is an oral tablet that blocks the effects of malfunctioning AKT proteins, which cause cancer growth.

Learn more here

The ReDiscover-2 Study is a randomized, open-label trial. “Randomized” means that if you are eligible to participate in the trial and choose to do so, you will be assigned to a treatment group and have an equal chance to receive either:

  • RLY-2608 in combination with fulvestrant
  • TRUQAP™ (capivasertib) in combination with fulvestrant

“Open-label” means that you and your study doctor will know which study treatment you are assigned to.

Study Design

Participation in the ReDiscover-2 Study consists of three periods:

Screening

A study oncologist and oncology nurse will evaluate you to see if the trial is a good match. You will first need to give your consent, or permission, to join the trial by reading and signing the informed consent form.

Treatment

If the trial is a good match for you and you agree to take part, you will begin undergoing study drug dosing cycles and attend regular trial site visits. You will be shown how to use a dosing diary at home to keep track of study drug dosing.

Follow-up

The trial team will monitor your health after you have stopped taking your assigned study drugs.

Study Timeline

The length of trial participation will be different for each participant, but it may last from several months to one year or longer.

The treatment period of this trial will be divided into cycles of 28 days each. The number of cycles you are on will depend on the effects of the study drugs and your overall health.

Understanding the PIK3CA Gene in HR+/HER2- Breast Cancer

HR+/HER2- locally advanced or metastatic breast cancer is a common type of breast cancer. In about 40% of cases, the cancer has a mutation – or change – in a gene called PIK3CA. A gene mutation is a change in your body’s instructions that can cause cells to behave differently than they should. In this case, the PIK3CA mutation causes a protein called PI3Kα to become overactive, helping cancer cells grow and survive. This can make the cancer grow faster and may make hormone (endocrine) therapy less effective over time.

Testing for this mutation can be done through a blood test or a sample of tumor tissue (biopsy). While it’s helpful to test early, testing can happen at any point after diagnosis. The ReDiscover-2 Study is evaluating an investigational treatment that is designed to more precisely target the PIK3CA mutation. This approach may help better control cancer growth and reduce side effects compared to less targeted treatments.

Find a Participating Research Site

If you're interested in participating in this trial, enter your zip/postal code to find a nearby research site. To learn more or ask questions, please email the Relay Therapeutics team at ClinicalTrials@relaytx.com – they can help guide you and connect you with the appropriate study site.

Active site locations

Future site locations

What You Should Know About Clinical Research Studies

Clinical trials, also called clinical research studies, help researchers answer specific questions about how medicines work in the people who take them. These studies are a critical step in the process of getting new drugs approved for public use. If you’re considering joining a clinical trial, you should feel fully informed about what to expect from your participation.

Researchers use clinical research studies to:

  • Learn about the safety and effects of investigational medicines, which have not yet been approved and are being tested
  • Help find new ways of using certain medications
  • Work on new therapeutic options
  • Answer specific health questions

Participation in any clinical trial is voluntary (your choice). The study team will inform you of the potential risks and benefits of participation, as well as possible side effects. To make an informed decision, talk to your healthcare providers about any questions you may have.

Throughout the trial, the study doctor will perform certain tests and procedures at each of the trial visits. These may include reviewing your medications and how you’ve been feeling, measuring vital signs (such as blood pressure, temperature, and heart rate), performing physical exams, collecting blood and urine samples for lab tests, conducting heart tests such as electrocardiograms (ECGs) or echocardiograms, reviewing your study drug diary, and performing other assessments as needed.

You’ll be asked to keep a dosing diary at home to help track when and how you take the study drug. It’s important to complete the diary each day during your dosing cycles, following the instructions provided by the trial staff. This helps the research team monitor your progress and ensure the study drug is taken as planned.

Participation in the ReDiscover-2 Study will be different for each participant, but may last from several months to one year or longer. This includes a screening period, a treatment period, and a follow-up period.

Find a participating site