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Study of Trastuzumab, Pertuzumab, and Chemotherapy Combination with Response-Guided Treatment for Patients with HER2-Positive 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 study focuses on patients with HER2-positive breast cancer. The research aims to evaluate whether reducing chemotherapy guided by imaging can be effective when combined with two medications that target HER2: Herceptin (trastuzumab) and Perjeta (pertuzumab). These medications are specifically designed to treat breast cancers that have high levels of a protein called HER2 on their surface.

The treatment plan includes several medications given through intravenous infusion or injection. Patients will receive paclitaxel and carboplatin as chemotherapy drugs, along with Herceptin and Perjeta which target the cancer cells. Some patients may also receive Kadcyla (trastuzumab emtansine), which combines Herceptin with another anti-cancer substance.

Throughout the study, doctors will use imaging tests to monitor how well the treatment is working. Based on these results, they may adjust the amount of chemotherapy given. The main goal is to see if this approach can effectively treat the cancer while potentially reducing the amount of chemotherapy needed. Patients will be monitored for at least three years after starting treatment to evaluate the long-term effectiveness of this approach.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive a combination of medications through intravenous infusion (directly into your vein), including:

    - Herceptin (trastuzumab)

    - Perjeta (pertuzumab)

    - Paclitaxel

    - Carboplatin

  2. Step 2

    Treatment monitoring

    Your response to treatment will be monitored using:

    - Breast MRI scans (detailed images of your breast tissue)

    - Ultrasound examinations of lymph nodes

    Your heart function will be regularly checked using heart imaging tests to ensure the treatment is safe

  3. Step 3

    Treatment adjustment

    Based on how your cancer responds, your treatment may be adjusted after 3, 6, or 9 cycles

    The medication Kadcyla (trastuzumab emtansine) may be used as an alternative treatment option

  4. Step 4

    Alternative administration option

    Herceptin may be given either:

    - Through an intravenous infusion, or

    - As an injection under the skin (subcutaneous injection)

  5. Step 5

    Follow-up period

    After completing treatment, you will be monitored for at least three years to track your progress

    Regular check-ups will assess your overall health and cancer status

Who can join the trial?

11 criteria

  • Must have confirmed breast cancer that has spread into surrounding breast tissue
  • Must be at least 18 years old
  • Must have stage II or III breast cancer, confirmed by examination including ultrasound
  • Must have a tumor that tests positive for HER2 (a protein that promotes cancer cell growth)
  • Must have known hormone receptor status (estrogen and progesterone) of the tumor
  • Must have a tumor that is visible on MRI with contrast dye and/or affected lymph nodes
  • Must be able to perform daily activities with minimal limitations (WHO performance status of 0 or 1)
  • Must have adequate blood test results showing: - Healthy bone marrow function - Normal liver function - Normal kidney function (creatinine clearance above 50 ml/min)
  • Must have good heart function (heart ejection fraction of 50% or higher)
  • If able to have children, must agree to use effective birth control during treatment and for 7 months after the last dose
  • Women who can become pregnant must have a negative pregnancy test

Who cannot join the trial?

12 criteria

  • Patients with metastatic breast cancer (cancer that has spread to other parts of the body)
  • Previous treatment with chemotherapy or targeted therapy for breast cancer
  • Known severe allergic reactions to Herceptin or pertuzumab (the study medications)
  • Significant heart problems, including heart failure or poorly controlled high blood pressure
  • Pregnancy or breastfeeding
  • Active or uncontrolled serious infections
  • Other active cancers in the past 5 years (except successfully treated skin cancer or cervical cancer)
  • Serious medical conditions that could interfere with study participation
  • Mental health conditions that could affect ability to comply with the study protocol
  • Participation in another clinical trial within the past 30 days
  • Known problems with liver or kidney function that could affect treatment safety
  • History of other medical conditions that could affect the safety of study treatments
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Investigated drugs

Herceptin (trastuzumab) is a targeted therapy medication used to treat HER2-positive breast cancer. It works by attaching to HER2 proteins on cancer cells, helping to stop them from growing and dividing. It is commonly used in combination with other treatments and has been shown to be effective in both early and advanced stages of breast cancer. Pertuzumab is another targeted therapy medication used in treating HER2-positive breast cancer. It works differently from Herceptin by preventing HER2 proteins from pairing with other HER2 proteins. When used together with Herceptin, it provides a more complete blockade of HER2 signaling, which can lead to better treatment outcomes. Both medications are given together as "dual HER2-blockade" therapy, which means they work in combination to more effectively target and treat HER2-positive breast cancer cells. This combination approach has become a standard treatment option for many patients with HER2-positive breast cancer.

What is already known about the treatment

  • Herceptin

    A targeted biological therapy administered intravenously that has become a standard treatment for HER2-positive breast cancer. This monoclonal antibody works by attaching to HER2 proteins on cancer cells, blocking their growth signals and helping the immune system identify and destroy these cells. As part of the established treatment protocol, it belongs to the class of targeted cancer therapies and has shown significant success in both early-stage and metastatic breast cancer treatment when combined with chemotherapy or other targeted agents like pertuzumab.

  • Pertuzumab

    An intravenously administered targeted therapy drug that works in combination with Herceptin for treating HER2-positive breast cancer. This medication attaches to a different area of the HER2 protein than Herceptin, providing complementary blocking action against cancer cell growth signals. It belongs to the monoclonal antibody class of cancer treatments and has demonstrated improved outcomes when used as part of dual HER2-blockade therapy, particularly in the neoadjuvant (pre-surgery) setting for breast cancer treatment.

Investigated diseases

Breast cancer - A disease that begins when cells in the breast begin to grow out of control. These cells usually form a tumor that can be seen on an x-ray or felt as a lump. The cancer starts in the cells of the breast tissue, most commonly in the ducts that carry milk to the nipple or the glands that make breast milk. Over time, cancer cells can invade nearby healthy breast tissue and make their way into the underarm lymph nodes. If cancer cells get into the lymph nodes, they then have a pathway into other parts of the body. The disease can occur in both women and men, though it's much more common in women. Breast cancer cells can grow at different rates, with some growing and spreading more quickly than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516205-23-00Protocol codeBOOG 2018-01Estimated enrolment472 patientsSponsorBOOG Study Center B.V.

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