Study of Atezolizumab, Pertuzumab, and Trastuzumab for Patients with HER2 Positive Early High-Risk and Locally Advanced Breast Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for HER2-positive breast cancer, which is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). This protein promotes the growth of cancer cells. The study involves several medications, including Atezolizumab, Pertuzumab, and Trastuzumab, which are used in combination with chemotherapy. These medications are designed to target and block the HER2 protein, helping to slow or stop the growth of cancer cells.

The purpose of the study is to compare the effectiveness of different treatment combinations in improving the 5-year event-free survival of patients. Event-free survival refers to the length of time after treatment during which a patient remains free from certain complications or events that the study is measuring. Participants will receive treatment over a period of time, and their health will be monitored to assess the outcomes. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, participants will undergo regular health assessments to monitor their response to the treatment. The study aims to provide valuable information on the best treatment strategies for patients with HER2-positive breast cancer, potentially leading to improved outcomes and survival rates. The trial is expected to conclude by the end of 2026, with results helping to guide future treatment approaches for this type of cancer.

1 joining the study

Upon joining the study, participation is confirmed through written informed consent. This consent is necessary before any study-specific procedures begin.

2 initial assessments

Initial assessments include confirming the diagnosis of HER2 positive invasive breast cancer and ensuring eligibility criteria are met. This involves reviewing medical history and performing necessary tests.

3 treatment phase

The treatment phase involves receiving medications as part of the study. The medications include trastuzumab emtansine, pertuzumab, atezolizumab, and chemotherapy.

Medications are administered either intravenously or subcutaneously, depending on the specific drug. The frequency and dosage are determined by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes blood tests and imaging studies.

Follow-up visits are scheduled to evaluate the effectiveness of the treatment and to ensure the patient’s well-being.

5 end of treatment

At the end of the treatment phase, a final assessment is conducted to determine the overall response to the therapy.

The study aims to compare the 5-year Event-Free Survival (EFS) between different treatment groups.

Who Can Join the Study?

  • Female patients aged 18 years or older with early high-risk or locally advanced and inflammatory breast cancers that are suitable for treatment before surgery.
  • Willing and able to follow the study’s rules and procedures.
  • Confirmed diagnosis of invasive breast cancer in one breast.
  • HER2 positive disease according to current guidelines. HER2 is a protein that can affect the growth of cancer cells.
  • Known levels of estrogen receptor (ER) and progesterone receptor (PgR). These are proteins that can influence how breast cancer behaves.
  • A sample of the tumor, preserved in a special way, must be available for testing to confirm HER2 status and to check other markers.
  • Agree to give blood samples at specific times during the study, including before starting treatment, after the first cycle, before surgery, six months after surgery, and at the end of all treatments.
  • ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
  • For women who are not postmenopausal or surgically sterile, they must agree to use effective birth control methods during the study and for at least 7 months after the last dose of study drugs. Abstinence is only acceptable if it is the patient’s usual lifestyle. Certain methods like periodic abstinence and withdrawal are not acceptable.
  • Written informed consent to participate in the trial must be obtained before any study-specific procedures begin. This means the patient agrees to join the study after understanding all the details.

Who Cannot Join the Study?

  • Patients who do not have invasive breast cancer cannot participate. Invasive breast cancer is a type of cancer that has spread from the original site in the breast to other parts of the body.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Hospital Universitario De Navarra Pamplona Spain
MVZ Onko Medical GmbH Hannover Hanover Germany

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Istituto Europeo Di Oncologia S.r.l. Milan Italy
ASST Fatebenefratelli Sacco Milan Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
SRH Wald-Klinikum Gera GmbH Gera Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Hospital Del Mar Barcelona Spain
Hospital San Pedro De Alcantara Caceres Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitario Basurto Bilbao Spain
Hospital Virgen De Los Lirios Alcoy Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
MD Anderson Cancer Center Madrid Spain
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Marienhospital Bottrop gGmbH Bottrop Germany
Klinikum Magdeburg gGmbH Magdeburg Germany
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Locale Di Taranto Taranto Italy
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Vincentius-Diakonissen-Kliniken gAG Karlsruhe Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Gasthuiszusters Antwerpen Antwerp Belgium
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Centro Oncologico De Galicia A Coruna Galicia Spain
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Illccp Imaqielp Furdgnnjexmhh Oxtepivpglm Rome Italy
Hvrgzlkr Ujalasavqevke Df Bjbeftj Badajoz Spain
Ihsmiszp Rkhxrmyng Ptj Lz Sdxmgn Dfo Txqjls Dmmb Avakcsi Ibsh Sqvlzb Meldola Italy
Hsontlsb Umokoaryovonz Dkzvvaqt Donostia / San Sebastian Spain
Arttsks Uqk Ibpum De Rxdfut Emirpe Reggio Emilia Italy
Kifex Siq Psooab Gynj Dortmund Germany
Hmcadsgg Dw Lg Srzvg Cron I Svqt Pfg Barcelona Spain
Uciejiykgu Ol Ajzugsk Edegem Belgium
Aafsvhn Ounuhhtapnw Pyjr Gwemfolq Xopte Bergamo Italy
Myufondyivafinnkroxurglylw Hlsdhxfiosdlaalz Halle (Saale) Germany
Mrfsnu Hpcjpmtb Wfmwye Witten Germany

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
30.07.2018
Belgium Belgium
Not yet recruiting
30.07.2018
Germany Germany
Not yet recruiting
30.07.2018
Italy Italy
Not yet recruiting
30.07.2018
Romania Romania
Not yet recruiting
30.07.2018
Spain Spain
Not yet recruiting
30.07.2018

Trial locations

Atezolizumab is a medication used to help the immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

Pertuzumab is a medication that targets a specific protein on the surface of cancer cells. It helps to stop the growth and spread of cancer by blocking signals that tell the cancer cells to grow.

Trastuzumab is a medication used to treat certain types of breast cancer. It works by attaching to a protein on the surface of cancer cells, which helps to stop the cells from growing and dividing.

Chemotherapy involves the use of drugs to kill or slow the growth of cancer cells. It is often used in combination with other treatments to increase its effectiveness in treating cancer.

Invasive Breast Cancer – This is a type of breast cancer that has spread from the original site in the breast ducts or lobules into surrounding breast tissue. It can further progress by spreading to nearby lymph nodes and potentially to other parts of the body. The disease often begins as a lump or mass in the breast, which may be detected through physical examination or imaging tests. As it advances, symptoms can include changes in breast shape, skin dimpling, or nipple discharge. The progression of invasive breast cancer can vary, with some cases growing slowly while others may spread more rapidly. Understanding the specific characteristics of the cancer, such as hormone receptor status, is crucial in determining its behavior and potential progression.

Trial ID:
2024-518026-32-00
Protocol code:
FM-17-B01
NCT ID:
NCT03595592
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of elacestrant and ribociclib compared to standard treatment for patients with high-risk ER+/HER2- early breast cancer

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Germany Spain
  • Study of personalized tamoxifen dosing (10mg, 20mg, or 40mg daily) compared to standard dose (20mg) in women with breast cancer to improve treatment continuation

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden