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Study of RO7247669 and Nab-Paclitaxel vs. Pembrolizumab and Nab-Paclitaxel for Patients with Untreated, PD-L1 Positive, Advanced Triple-Negative Breast Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as Triple-Negative Breast Cancer (TNBC). This form of cancer does not have three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. The study is investigating the effectiveness of two different treatment combinations for patients with TNBC that is either locally advanced and cannot be surgically removed or has spread to other parts of the body (metastatic). The treatments being compared are RO7247669 combined with nab-paclitaxel and pembrolizumab combined with nab-paclitaxel.

RO7247669 is a new medication being tested, while nab-paclitaxel is a form of chemotherapy that uses a protein called albumin to help deliver the drug paclitaxel to cancer cells. Pembrolizumab, also known as Keytruda, is an immunotherapy drug that helps the immune system recognize and attack cancer cells. The purpose of the study is to evaluate how well these treatment combinations work in terms of delaying the progression of the disease.

Participants in the study will receive one of the two treatment combinations through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted over a period of time, with regular monitoring to assess the response to the treatment. The goal is to determine which combination is more effective in managing the cancer and improving the quality of life for patients with TNBC.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide your consent to participate in the study. This involves signing a document that confirms you understand the trial and agree to take part.

  2. Step 2

    Screening tests

    You will undergo a series of screening tests to ensure you meet the study's eligibility criteria. These tests may include blood tests, imaging scans, and assessments of your overall health and organ function.

  3. Step 3

    Randomization

    If you qualify for the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment being studied.

  4. Step 4

    Treatment administration

    You will receive your assigned treatment through an intravenous infusion, which means the medication will be given directly into your vein. The treatments being studied are RO7247669 combined with nab-paclitaxel or pembrolizumab combined with nab-paclitaxel.

    The specific dosage and frequency of the medication will be determined by the study protocol and your healthcare team. The duration of the treatment period will also be specified by the study.

  5. Step 5

    Regular follow-up visits

    Throughout the study, you will have regular follow-up visits with the study team. These visits are important to monitor your health, assess the effectiveness of the treatment, and manage any side effects you may experience.

    During these visits, you may undergo additional tests and assessments as required by the study protocol.

  6. Step 6

    End of treatment

    Once the treatment period is complete, you will have a final visit to assess your overall health and the outcomes of the treatment. This visit may include tests and evaluations similar to those conducted during the study.

  7. Step 7

    Long-term follow-up

    After the end of the treatment, you may be asked to participate in long-term follow-up visits. These visits help the study team gather information about the long-term effects and benefits of the treatment.

Who can join the trial?

11 criteria

  • Must have Triple-Negative Breast Cancer (TNBC), which means the cancer does not have certain receptors known as HER2, estrogen, and progesterone.
  • The cancer must be metastatic (spread to other parts of the body) or locally advanced unresectable (cannot be removed by surgery).
  • Must have a measurable disease according to specific medical criteria, and if the disease is metastatic, it should be measurable outside of the bone.
  • Must not have received any previous systemic therapy (treatment affecting the entire body) for metastatic or locally advanced unresectable TNBC.
  • The tumor must show PD-L1 expression, which is a specific protein found on the tumor, confirmed by a central test.
  • Must have an ECOG Performance Status of 0 or 1, which means the person is fully active or has some symptoms but does not require bed rest.
  • Must have adequate blood and organ function, as shown by specific lab tests done within 14 days before starting the study treatment.
  • Must have adequate heart function.
  • Must test negative for HIV (Human Immunodeficiency Virus), negative for hepatitis B surface antigen, positive for hepatitis B surface antibody, and negative for hepatitis C virus antibody or have a negative hepatitis C RNA test if the antibody test is positive.
  • For male participants: Must agree to remain abstinent or use a condom during the treatment and for 4 months after the last dose of RO7247669 or pembrolizumab, and 6 months after the last dose of nab-paclitaxel. Must also refrain from donating sperm during this period.
  • For female participants of childbearing potential: Must agree to remain abstinent or use contraception during the treatment and for 4 months after the last dose of RO7247669 or pembrolizumab, and 6 months after the last dose of nab-paclitaxel. Must also refrain from donating eggs during this period.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides Triple-Negative Breast Cancer (TNBC) cannot participate.
  • Patients who have previously received treatment with the study drugs RO7247669 or pembrolizumab are not eligible.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are unable to comply with the study procedures or follow-up visits are not eligible.
  • Patients with known allergies to the study drugs or their components cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients with active infections that require treatment are not eligible.
  • Patients with a history of severe allergic reactions to similar drugs are excluded.
  • Patients with certain heart conditions that could be worsened by the study drugs cannot participate.
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Investigated drugs

  • RO7247669

    is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat a specific type of breast cancer known as triple-negative breast cancer, which is difficult to treat. This medication is being combined with another drug to see if it can improve the outcomes for patients with this type of cancer.

  • Nab-paclitaxel

    is a type of chemotherapy drug used in this trial. It works by stopping cancer cells from growing and dividing, which can help slow down or stop the spread of cancer. In this study, it is used in combination with other medications to see if it can be more effective in treating triple-negative breast cancer.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It works by blocking a specific protein that prevents the immune system from attacking cancer cells. By blocking this protein, pembrolizumab can help the immune system recognize and destroy cancer cells more effectively. In this trial, it is combined with nab-paclitaxel to see if this combination can improve treatment outcomes for patients with triple-negative breast cancer.

What is already known about the treatment

  • RO7247669

    This medication is administered in combination with nab-paclitaxel, typically through intravenous infusion, which means it is given directly into the bloodstream. It is currently being studied in clinical trials for its effectiveness in treating triple-negative breast cancer (TNBC), particularly in cases that are locally advanced, unresectable, or metastatic. The main therapeutic goal is to improve progression-free survival, which means extending the time patients live without the cancer worsening. RO7247669 works at the molecular level by targeting specific proteins involved in cancer cell growth, helping to slow down or stop the spread of cancer cells. It is classified as an investigational drug, meaning it is still under study and not yet approved for general medical use.

  • Pembrolizumab

    This medication is also administered in combination with nab-paclitaxel through intravenous infusion. It is an established treatment in the medical field, particularly for various types of cancer, including triple-negative breast cancer (TNBC) that is PD-L1 positive, locally advanced, or metastatic. Pembrolizumab is used to help the immune system recognize and attack cancer cells, thereby slowing down the progression of the disease. It works by blocking a specific protein that prevents the immune system from attacking cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Triple-Negative Breast Cancer (TNBC) – Triple-Negative Breast Cancer is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. This absence makes it distinct from other breast cancer types and influences its behavior and treatment approach. TNBC tends to grow and spread more quickly than other types of breast cancer. It is more likely to be diagnosed in younger women and is more common in women with a BRCA1 gene mutation. The progression of TNBC can vary, but it often involves rapid growth and a higher likelihood of spreading to other parts of the body. Understanding its unique characteristics is crucial for managing its progression effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502457-34-00Protocol codeCO44194Estimated enrolment160 patientsSponsorF. Hoffmann-La Roche AG

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