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

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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

Site Name City Country Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland

Verified Sites

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

Other Sites

Site Name City Country Status
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Ospedale San Raffaele S.r.l. Milan Italy
Karolinska University Hospital Solna Sweden
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Cardiomed S.R.L. Cluj Napoca Romania
Oncopremium Team S.R.L. Baia Mare Romania
Centre De Cancerologue Du Grand Montpellier Montpellier France
Lhuah Gnmvakx Hanpcthf Og Awtooq Athens Greece
Ighwfjbi Pnaqytyrbyaraii Cbtkfw Cxuayq Marseille France
Udyzhclrhgxncvfwpbhoz Eqoechwq Avc Erlangen Germany
Anadzdgdl Hrcngwiz Athens Greece
Sxubgvlcf Rfpiefw Ushgqhgdtg Mvsmhpl Crhejt Nijmegen The Netherlands
Ufbyeufjyu Os Seumuc Szeged Hungary
Uluojqzlwb Hdctivdt Mfcrxogdtq Maastricht The Netherlands
Cafifr Hirsycrbmn Upfwdzzubaepr Do Sprcw Audavkj Edmiau Porto Portugal
Cugezh Llmz Begren Lyon France
Uqtizipvjp Glxlish Hjsbhysh Oh Hnnzedlsz Heraklion Greece
Flajvlfusw Iyvad Skp Gkjfrln Dpl Tgqjphu Monza Italy
Cbgbuw Hvcwl Bxaleowhe Rouen France
Chfxmrr Dh Ovgtuwmzp Sp Nzussaer Syqtqw Craiova Romania
Sdimdqdzlo Sypoksxa Skfwkf Suceava Romania
Bjuevwidsax Vvldhrczc Oqrtezxijdtj Kecskemet Hungary
Cbnthv Obwsh Lraxnyj Lille France
Lhf Mot Oeburjatt Stj z olxn Warsaw Poland
Apfewwn Ohuplbwgvpo Pxn Lpuuulxojrjxtzuyp Cghxxmckff Catania Italy
Bpzfwuic Ubqfgzmsrn Hmefpcrf Ccczek Besançon France
Clnlyxgrwlem Czgjmhmm Chdxez Lisbon Portugal
Mrtlmji Mwkljjv Cwkrnv Amersfoort The Netherlands
Hnfertxc Uclrhxfacxtgg Qnjqmtfzqik Mzcwsv Pozuelo De Alarcon Spain
Spl Ezuwnzhib Hypnlbst Tfnurmm Tilburg The Netherlands
Snfh Fvrgjlrmpv Vkhyanezi Gvgjk Skagkbmtr Rotterdam The Netherlands
Pafgwn Sxea Skorzewo Poland
Mratgtt Cmjsol Hdrqwepkjf Leidschendam The Netherlands
Nkdtvaal Ilihkmzs Owhcovgvl Iuj Melot Sfzyrmsfyaifyupbbrxstliqvcfs Iqozegfn Bsspjrlb Cracow Poland
Sp Vbaqixxczoltgjt Usjdwnizwr Hmxmrhyn Dublin Ireland
Uhplbvapqx Oz Pnha Pecs Hungary
Cflyhzs Oqqxpmxbl Ijf Pfsqy Ffnbdxjqor Lvyudeckrkj W Brzwipbtri Bydgoszcz Poland
Nrbmsaopjkc Cleiuk Idaptzyqk Amsterdam The Netherlands
Chxqmr Hsffkcbsfcb Uedwptzgmlxfq Dy Pmrwxmiq Poitiers France
Ledyn Ugktnyxkwjny Mxyemfh Covmeht (ycetl Leiden The Netherlands
Vdqwxvlt Nqnbqsbn frbb Gcoqqazdkz Ghgs Berlin Germany
Jkgcdm Bjfbh Zdkykrrvnf Sspclhxco S-Hertogenbosch The Netherlands
Sqdclh Aibhlzznj Hdoqhmeb Vvhagnh Gljajalxsxxeilqcsr Boras Sweden
Etlupljcqk Glnvlnl Cfowdq Os Thydtserjggs Thessaloniki Greece
Sztl Cjdxe Gurcqmfmnx Salzburg Austria
Bgqhwbdeajjp Cxovjgs Oplexknvn Ipi Muvbh Smzuurmdhdjujlhjxt W Bvquzrjtduz Bialystok Poland
Uvyudls Lyebn Dm Sinif Db Mkxqutjxza Ealyle Senhora Da Hora Portugal
Myjeostimn Skcydun Ozgrmzsnskuv Sem z otcf Wieliszew Poland
Kmdnutaf Edhupphhjfxccjwruxltbbun Hssmwdbycchwfszln Essen Germany
Wzizmqfojx Shkepob Ity Shtxtsh Plr W Pfvcuxesa 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.

Investigated Diseases:

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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