Study of Trastuzumab, Pertuzumab, and Chemotherapy Combination with Response-Guided Treatment for Patients with HER2-Positive Breast Cancer

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What is this study about?

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.

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 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 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 Alternative administration option

Herceptin may be given either:

– Through an intravenous infusion, or

– As an injection under the skin (subcutaneous injection)

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
Frisius Heerenveen The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Ziekenhuis Rivierenland Tiel The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Diakonessenhuis Stichting Utrecht The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Ziekenhuis St Jansdal Harderwijk The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
Het Van Weel-Bethesda Ziekenhuis Dirksland The Netherlands
Ziekenhuis Nij Smellinghe Drachten The Netherlands
Ziekenhuis Amstelland Amstelveen The Netherlands
Rode Kruis Ziekenhuis B.V. Beverwijk The Netherlands
Bernhoven B.V. Uden The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Zaans Medisch Centrum Stichting Zaandam The Netherlands
Gelre Hospitals Zutphen The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Rrcnambbk Zncyqelaib Swvqwxaof Arnhem The Netherlands
Sptmklekv Mbeiqoz Zhiozaexff Groningen The Netherlands
Lhgjvbmknp Zxccrkovjg Rgnusxjh Roermond The Netherlands
Bmpxsck Zgjwdwlmmd Gorinchem The Netherlands
Svhhloyubjpvoecd Kusutbyz Bpexxra Winterswijk The Netherlands
Srxvmcn Geldrop The Netherlands
Sxb Eeigmiekb Hmrhlvei Ttfutqz Tilburg The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.10.2018

Trial locations

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.

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 ID:
2024-516205-23-00
Protocol code:
BOOG 2018-01
NCT ID:
NCT03820063
Trial Phase:
Therapeutic exploratory (Phase II)

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