Study of Pembrolizumab with Chemotherapy for High-Risk Early-Stage ER+/HER2- Breast Cancer Patients

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as ER+/HER2- breast cancer, which is a form of cancer that tests positive for estrogen receptors but negative for a protein called HER2. The study is investigating the effects of a medication called pembrolizumab, also known by its code name MK-3475, in combination with other cancer treatments. Pembrolizumab is a type of medication that helps the immune system fight cancer cells. The trial will compare pembrolizumab with a placebo, which is a substance with no active medication, to see how effective it is when used alongside standard cancer treatments.

The purpose of the study is to evaluate how well pembrolizumab works in combination with chemotherapy and hormone therapy for patients with high-risk early-stage ER+/HER2- breast cancer. Participants in the study will receive either pembrolizumab or a placebo, along with chemotherapy drugs such as epirubicin, paclitaxel, doxorubicin, and cyclophosphamide. These chemotherapy drugs are commonly used to treat breast cancer and work by killing cancer cells or stopping them from growing. The study will follow participants through their treatment and recovery to assess the effectiveness of the treatment combinations.

Throughout the study, participants will undergo various treatments and assessments to monitor their response to the medication and any side effects they may experience. The trial aims to determine if pembrolizumab can improve outcomes for patients with this type of breast cancer, such as achieving a complete response to treatment or extending the time without cancer progression. The study will provide valuable information on the potential benefits of adding pembrolizumab to the standard treatment regimen for high-risk early-stage ER+/HER2- breast cancer.

1 initial treatment phase

The initial phase involves the administration of pembrolizumab or a placebo. This is given as an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

During this phase, pembrolizumab is combined with neoadjuvant chemotherapy. Neoadjuvant chemotherapy is treatment given before surgery to shrink the tumor.

The chemotherapy drugs used include epirubicin, paclitaxel, and cyclophosphamide. These are also administered through intravenous infusion.

2 surgery

After completing the initial treatment phase, surgery is performed to remove the tumor. The goal is to achieve a pathological complete response, meaning no cancer is found in the tissue samples taken during surgery.

3 adjuvant therapy

Following surgery, adjuvant therapy is administered. This includes additional doses of pembrolizumab or placebo, combined with endocrine therapy.

Endocrine therapy involves medications that block hormones which can promote cancer growth. This is particularly relevant for estrogen receptor-positive breast cancer.

4 follow-up

Regular follow-up appointments are scheduled to monitor health and check for any signs of cancer recurrence.

During these visits, assessments may include physical exams, imaging tests, and laboratory tests to evaluate overall health and response to treatment.

Who Can Join the Study?

The patient must have a type of breast cancer called ER+/HER2- breast cancer, which is a specific kind of breast cancer.
The patient must have a localized invasive breast ductal adenocarcinoma, which means the cancer is in the breast ducts and has not spread far. The tumor size should be at least 2 cm, or it should be at certain stages (T1c-T2, cN1-cN2, or T3-T4, cN0-cN2). Inflammatory breast cancer is also allowed.
The patient must have a specific grade of breast cancer (Grade 3) confirmed by a pathologist, following certain guidelines.
The patient must provide a new or recent core needle biopsy, which is a sample of the breast tumor taken with a needle, to check certain cancer characteristics.
The patient must have an ECOG performance status of 0 or 1, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but still able to do light work.
Male participants must agree to use contraception during the treatment and for a certain period after the last dose, and they should not donate sperm during this time.
Female participants must agree to use effective contraception during the treatment and for a certain period after the last dose.
The patient must have adequate organ function, meaning their organs are working well enough to handle the treatment.

Who Cannot Join the Study?

Patients with a different type of breast cancer than ER+/HER2- cannot participate. ER+/HER2- refers to a specific type of breast cancer that has certain characteristics related to hormone receptors and proteins.
Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study and may vary.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding are usually excluded from participating in clinical trials.
Patients who have participated in another clinical trial recently may not be eligible to join this study.
Patients with certain medical conditions that could interfere with the study or increase risk may be excluded.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, are not eligible.
Patients who have allergies or reactions to the study medications or similar drugs may be excluded.
Patients with a history of certain diseases or conditions that could affect the study results may not be allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Suedharz Klinikum Nordhausen gGmbH	Nordhausen	Germany
Centre Jean Perrin	Clermont Ferrand	France
Hospital Clinico San Carlos	Madrid	Spain
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
MVZ Onko Medical GmbH Hannover	Hanover	Germany
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Orszagos Onkologiai Intezet	Budapest	Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
St. Vincenz-Krankenhaus GmbH	Paderborn	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Az Maria Middelares Gent	Gent	Belgium
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Bon Secours Hospital Cork	Cork	Ireland
Hospital Universitario De Jaen	Jaen	Spain
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Institut Sainte Catherine	Avignon	France
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Mazowiecki Szpital Onkologiczny Sp. z o.o.	Wieliszew	Poland
Caritas Traegergesellschaft Saarbruecken mbH (CTS)	Saarbrücken	Germany
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej SPZOZ	Bielsko-Biala	Poland
Sana Klinikum Offenbach GmbH	Offenbach Am Main	Germany
Hospital Quironsalud Barcelona	Barcelona	Spain
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
University Of Pecs	Pecs	Hungary
Hopital Beaujon	Clichy	France
Budapesti Szent Margit Korhaz	Budapest	Hungary
Clinique Victor Hugo	Le Mans	France
Centre Francois Baclesse	Caen	France
Budapesti Uzsoki Utcai Korhaz	Budapest	Hungary
Ixwhosvb Ceoxko Dqoqcleutxpzgwmem	L'hospitalet De Llobregat	Spain
Sveqqcju Pxlhnruhh Soa z ogpx	Gdynia	Poland
Mthwksquik Syrqpks Sencuppctjeglan Iydbkonwdyey Pthihqsfwp W Ovxtrzwxe	Ostroleka	Poland
Bjpsuywzxfv Vddnpitod Oktjfdyxcahc	Kecskemet	Hungary
Ubk Mkhlaadqvvir	Yvoir	Belgium
Gsygvceupypzivwl Zbxvgzx Bzwu	Bonn	Germany
Nqggntzk Icanfrbe Oqythpsdm Irx Mkmkn Spyrplglpkkgaghffzhxdlolbtib Isipffsh Bwzqnjsg	Cracow	Poland
Kffaqskl dxh Uoltyxrpulpp Mhvookok Ape	Munich	Germany
Uahpbounqi Oo Ayvhmwl	Edegem	Belgium
Kaeqxmxb Egrongggxbrtdxwxqgidsebc Hsggmqllwmqyijooe	Essen	Germany
Hsqnfmdw Vdnw dyuestyi	Barcelona	Spain
Cysbik Ovmvh Lcqifik	Lille	France
Hrdhqftq Upicllwzoejbm dj A Cafrzf	A Coruna Galicia	Spain
Igoosbvl Ctaqe	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	27.12.2018
France	Not recruiting	27.12.2018
Germany	Not recruiting	27.12.2018
Hungary	Not recruiting	27.12.2018
Ireland	Not recruiting	27.12.2018
Poland	Not recruiting	27.12.2018
Portugal	Not recruiting	27.12.2018
Spain	Not recruiting	27.12.2018

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the body’s immune system fight cancer cells. It is being tested to see if it can improve outcomes for patients with a specific type of breast cancer when used alongside other cancer treatments. Pembrolizumab works by blocking a protein that stops the immune system from attacking cancer cells, potentially allowing the immune system to better target and destroy these cells.

Neoadjuvant Chemotherapy refers to cancer-fighting drugs given before surgery to shrink tumors and make them easier to remove. In this trial, neoadjuvant chemotherapy is used in combination with pembrolizumab to see if this approach can improve the effectiveness of the treatment for breast cancer.

Adjuvant Endocrine Therapy is a treatment given after the primary treatment, such as surgery, to help prevent cancer from returning. It involves medications that block or lower the amount of hormones in the body, as some breast cancers grow in response to hormones. This therapy is used in the trial to see if it can further reduce the risk of cancer recurrence when combined with pembrolizumab and chemotherapy.

Investigated diseases:

Hormone receptor positive HER2 negative breast cancer

ER+/HER2- Breast Cancer – This is a type of breast cancer characterized by the presence of estrogen receptors (ER+) and the absence of human epidermal growth factor receptor 2 (HER2-). It means that the cancer cells grow in response to the hormone estrogen but do not have an excess of the HER2 protein on their surfaces. This type of breast cancer tends to grow more slowly than other types and may have a different pattern of spread. It is often diagnosed through a combination of imaging tests and biopsy. The progression of this cancer can vary, but it typically involves the growth of tumors in the breast tissue, which may eventually spread to nearby lymph nodes or other parts of the body.

Trial ID:

2023-506921-12-00

Protocol code:

MK-3475-756

NCT ID:

NCT03725059

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab with Chemotherapy for High-Risk Early-Stage ER+/HER2- Breast Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?