Study of Pembrolizumab and Chemotherapy for Patients with HR+/HER2- Advanced Breast Cancer

3 1 1

What is this study about?

This clinical trial is focused on studying a type of breast cancer known as hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. This type of cancer can be locally recurrent, meaning it has come back in the same area, or metastatic, meaning it has spread to other parts of the body. The study is investigating the effects of a treatment called pembrolizumab, also known by its code name MK-3475 or Keytruda, in combination with chemotherapy. Pembrolizumab is a medication that helps the immune system fight cancer cells. The chemotherapy drugs being used in this study include paclitaxel, doxorubicin, capecitabine, and their variations, such as paclitaxel albumin-bound and doxorubicin hydrochloride, liposomal. Some participants will receive a placebo instead of pembrolizumab to compare the effects.

The purpose of this study is to see if pembrolizumab combined with chemotherapy is more effective than chemotherapy alone in treating this type of breast cancer. Participants will be randomly assigned to receive either the pembrolizumab and chemotherapy combination or a placebo and chemotherapy. The study will monitor how long participants live without the cancer getting worse and overall survival rates. The study will also look at the quality of life and any side effects experienced by participants.

Participants will receive the treatment through an intravenous (IV) infusion, which means the medication is given directly into a vein. The study will last for a period of time, during which participants will have regular check-ups and assessments to monitor their health and the progress of the treatment. The study aims to provide valuable information on the effectiveness and safety of pembrolizumab in combination with chemotherapy for treating HR+/HER2- breast cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including the type of breast cancer and previous treatments.

A new biopsy may be required to confirm the cancer type and characteristics.

2 randomization

Participants are randomly assigned to one of two groups: one receiving pembrolizumab plus chemotherapy, and the other receiving a placebo plus chemotherapy.

3 treatment administration

Treatment involves intravenous administration of medications. Pembrolizumab is given as a solution for infusion.

Chemotherapy may include drugs such as paclitaxel, doxorubicin, paclitaxel albumin-bound, and doxorubicin hydrochloride, liposomal.

The specific chemotherapy regimen and schedule depend on the group assignment and individual treatment plan.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment and any side effects.

Assessments include imaging tests to evaluate tumor response and blood tests to monitor health status.

5 follow-up

After completing the treatment phase, follow-up visits are scheduled to continue monitoring health and any long-term effects of the treatment.

The duration of follow-up is determined by the study protocol and individual response to treatment.

Who Can Join the Study?

  • The patient must have locally recurrent inoperable or metastatic HR+/HER2- breast cancer that has not been treated with strong cancer drugs (cytotoxic chemotherapy) in a setting where the goal is not to cure the disease.
  • If the patient is a woman, she must not be pregnant or breastfeeding. She must either not be able to have children or use a very effective birth control method during the study and for a certain time after the last dose of the study drugs. She must also agree not to donate or store eggs for reproduction during this time.
  • The patient must have a measurable disease according to specific guidelines (RECIST 1.1), which means the cancer can be measured by doctors using scans or other methods.
  • If the patient is taking certain bone-strengthening medications (bisphosphonates or RANK ligand inhibitors), they must have been on a stable dose for at least 4 weeks before starting the study. If they need to start these medications during the screening period, a bone scan should be done before starting the study.
  • If the patient has Hepatitis B, they must have been on antiviral treatment for at least 4 weeks before the study and have no detectable virus in their blood.
  • If the patient has a history of Hepatitis C, they must have no detectable virus in their blood at the time of screening.
  • The patient must have tried hormone therapy before and now need chemotherapy. They must fit into one of several specific groups based on their previous treatments and how their disease has progressed.
  • The patient must have shown disease progression, meaning the cancer has grown or spread, as confirmed by a doctor or through a biopsy (a small sample of tissue taken for testing).
  • The patient must be a suitable candidate for chemotherapy as specified in the study protocol.
  • The patient must provide a new or recent biopsy sample from a cancerous area that has not been treated with radiation.
  • The patient must have a specific type of breast cancer confirmed by recent tests, with certain characteristics (PD-L1 CPS ≥1 and HR+/HER2-).
  • The patient must have a good general health status, as measured by a specific scale (ECOG performance status of 0 or 1), within 7 days before starting the study treatment.
  • The patient must have adequate organ function within 10 days before starting the study.
  • If the patient is male, he must agree to not donate sperm and either abstain from heterosexual intercourse or use contraception, including a condom, during the study and for at least 6 months after the last dose of chemotherapy.

Who Cannot Join the Study?

  • Patients who have already received cytotoxic chemotherapy for their breast cancer in a setting where the goal was not to cure the cancer cannot participate. Cytotoxic chemotherapy refers to drugs that kill cancer cells.
  • Patients with breast cancer that is not HR+/HER2- are excluded. HR+ means the cancer grows in response to hormones, and HER2- means the cancer does not have too much of a protein called HER2.
  • Patients with breast cancer that is not locally recurrent inoperable or metastatic are excluded. Locally recurrent inoperable means the cancer has come back in the same area and cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Centre Jean Perrin Clermont Ferrand France
IRCCS Humanitas Research Hospital Rozzano Italy
University Hospital Maastricht Maastricht The Netherlands
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Comite Entreprise Paul Papin Angers France
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Sigmedical Services S.R.L. Suceava Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Centre De Cancerologue Du Grand Montpellier Montpellier France
SCRI CCCIT Ges.m.b.H. Salzburg Austria
University General Hospital Of Heraklion Heraklion Greece
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Mazowiecki Szpital Onkologiczny Sp. z o.o. Wieliszew Poland
Oncopremium Team S.R.L. Baia Mare Romania
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Centre Henri Becquerel Rouen France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Alexandra Hospital Athens Greece
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
Champalimaud Clinical Centre Lisbon Portugal
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Meander Medical Center Amersfoort The Netherlands
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Pratia S.A. Skorzewo Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Medical Center Haaglanden Leidschendam The Netherlands
St Vincent’s University Hospital Dublin Ireland
Cardiomed S.R.L. Cluj Napoca Romania
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Netherlands Cancer Institute Amsterdam The Netherlands
University Of Szeged Szeged Hungary
Cmvjfv Lrjd Bozpqu Lyon France
Ligof Uatrhovuticj Mgtqige Crarhor (otdpg Leiden The Netherlands
Ljr Mrv Ofngsqxat Sla z omfr Warsaw Poland
Bmlhcgtknvv Vbrcuskgi Objaouwhjbno Kecskemet Hungary
Lrqzi Gwhjjbi Hdhsnwmk Oc Adkgit Athens Greece
Atejqpw Otpnkfdimgr Peu Lvwnglxuojtoxscdf Czlxzokfjo Catania Italy
Bonxwbig Uvmrllinls Hrjnqzfl Cujegi Besançon France
Ska Exjmvgbqo Hsrniwcn Tjbwtgt Tilburg The Netherlands
Nxygojyn Ilrvlffh Onvmnvckh Ibe Mejka Spppfznrhgwcpznsusxgqjlsvmtl Icdanqak Bdyuzymu Cracow Poland
Ktwiumtb Edoqqgedzjqdntsdpahpgqng Hdngapdipdygrgfgv Essen Germany
Izbuairy Pqgkqvoiakfradq Ciulfa Cpptsu Marseille France
Ccdsub Oilqr Lhaaysj Lille France
Wkbbupbuwl Synmyes Izo Slpblvq Pxk W Poqyqwgin Przemysl Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.08.2021
France France
Not recruiting
01.08.2021
Germany Germany
Not recruiting
01.08.2021
Greece Greece
Not recruiting
01.08.2021
Hungary Hungary
Not recruiting
01.08.2021
Ireland Ireland
Not recruiting
01.08.2021
Italy Italy
Not recruiting
01.08.2021
Poland Poland
Not recruiting
01.08.2021
Portugal Portugal
Not recruiting
01.08.2021
Romania Romania
Not recruiting
01.08.2021
Spain Spain
Not recruiting
01.08.2021
Sweden Sweden
Not recruiting
01.08.2021
The Netherlands The Netherlands
Not recruiting
01.08.2021

Trial locations

Pembrolizumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. This medication is being tested in combination with chemotherapy to see if it can improve outcomes for patients with certain types of breast cancer.

Chemotherapy refers to a group of cancer-fighting drugs used in this trial. These drugs work by killing or slowing the growth of cancer cells. In this study, chemotherapy is combined with pembrolizumab to evaluate if the combination is more effective than chemotherapy alone in treating breast cancer that is hormone receptor-positive and HER2-negative.

Locally Recurrent Inoperable or Metastatic HR+/HER2- Breast Cancer – This type of breast cancer is characterized by the recurrence of cancer cells in the breast or nearby areas after initial treatment, and it cannot be removed surgically. It is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), meaning the cancer cells grow in response to hormones but do not have excess HER2 protein. The disease can also spread to other parts of the body, known as metastasis. It progresses as cancer cells continue to grow and spread, affecting various organs and tissues. The progression can lead to symptoms such as pain, fatigue, and changes in the affected breast or other areas. This type of breast cancer has not been previously treated with cytotoxic chemotherapy in a noncurative setting.

Trial ID:
2023-506752-24-00
Protocol code:
MK-3475-B49
NCT ID:
NCT04895358
Trial Phase:
Therapeutic confirmatory (Phase III)

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