#1 Clinical Trials Search in Europe

Study on Avelumab for Patients with High-Risk Triple Negative Breast Cancer

1 1 1 1

What is this study about?

This clinical trial is focused on studying a type of breast cancer known as triple negative breast cancer. This form of cancer is called “triple negative” because the cancer cells do not have three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2/neu. The treatment being tested in this study is a medication called Avelumab, which is an anti-PD-L1 antibody. This medication is given as a solution through an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to find out if taking Avelumab for one year can help improve the time patients remain free from cancer after they have already received surgery and chemotherapy aimed at curing the cancer. The study will compare patients who receive Avelumab with those who are just observed without additional treatment. Patients participating in the study will have completed their initial treatment, which includes surgery to remove the tumor and chemotherapy to kill any remaining cancer cells.

Participants in the study will be randomly assigned to either receive the Avelumab treatment or be part of the observation group. The study will last for about a year, during which time the health of the participants will be closely monitored. The main goal is to see if Avelumab can help prevent the cancer from coming back. The study will also look at overall survival, which means how long patients live after starting the study, whether or not the cancer returns. This research aims to provide more information on whether Avelumab can be an effective additional treatment for patients with high-risk triple negative breast cancer.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving the medication avelumab and the other under observation without the medication.

The patient must have completed surgery and chemotherapy for high-risk triple negative breast cancer before joining the study.

2 treatment phase

If assigned to the treatment group, the patient will receive avelumab, which is administered as an intravenous infusion.

The dosage is 20 mg/mL of avelumab in a solution for infusion.

The treatment will last for one year, with infusions given every two weeks.

3 observation phase

Patients in the observation group will not receive avelumab but will be monitored regularly to assess their health status.

Both groups will have regular check-ups to monitor for any recurrence of cancer or other health issues.

4 end of study

The study aims to determine if one year of avelumab treatment improves disease-free survival compared to observation.

The primary endpoint is disease-free survival, which measures the time until any recurrence of cancer or the occurrence of a new cancer.

Who Can Join the Study?

  • Participants must be 18 years or older.
  • Participants must have had adjuvant chemotherapy after surgery. This means chemotherapy given after the main treatment to lower the risk of the cancer coming back. It should include at least 3 courses of an anthracycline agent and 3 courses of a taxane agent. If participants couldn’t complete all planned treatment cycles, they are still eligible.
  • No more than 10 weeks should pass between finishing adjuvant chemotherapy and starting the trial.
  • Participants must have normal organ and marrow function. This includes:
    • White blood count (WBC) at a certain level.
    • Absolute neutrophil count (ANC) at a certain level.
    • Absolute lymphocyte count at a certain level.
    • Platelet count at a certain level.
    • Hemoglobin at a certain level.
    • Estimated creatinine clearance at a certain level, which measures kidney function.
    • Adequate liver function, with specific levels of bilirubin and liver enzymes.
  • Participants must use highly effective contraception if there is a risk of pregnancy. This is because the effects of the trial treatment on a developing fetus are unknown.
  • Participants must be able to understand and be willing to sign a written informed consent. This means they agree to participate in the trial after being informed about it.
  • Participants must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG). This is a scale that measures how well a person can perform ordinary tasks.
  • Participants must have non-metastatic breast cancer, meaning the cancer has not spread to other parts of the body.
  • Participants must have triple negative breast cancer, which means the cancer cells do not have estrogen or progesterone receptors and do not have excess HER2 protein.
  • Participants must have completed treatment with the intent to cure, including surgery and chemotherapy.
  • Participants must have had adequate tumor excision, meaning the tumor was properly removed during surgery.
  • Participants must have had axillary lymph node dissection to check the status of lymph nodes. Eligibility depends on the number of metastatic lymph nodes and the size of the tumor.
  • Participants must have pathologic evidence of remaining invasive cancer in the breast or lymph nodes after preoperative therapy.
  • Participants must have a clinical stage of T1-4, N0-3, M0 at presentation, which describes the size and extent of the cancer.
  • Participants must have completed neoadjuvant chemotherapy before surgery, which is chemotherapy given before the main treatment to shrink the tumor.
  • Participants must provide a tumor tissue sample from before chemotherapy.

Who Cannot Join the Study?

  • Patients who have not completed treatment with the intent to cure, including surgery and chemotherapy, cannot participate.
  • Patients who have not undergone surgery of the primary tumor followed by chemotherapy, or chemotherapy followed by surgery, are excluded.
  • Patients who do not have high-risk primary triple negative breast cancer are not eligible. Triple negative breast cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who do not meet the gender requirements for the study are excluded.
  • Patients who are considered part of a vulnerable population, which may include those unable to give informed consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Sanitaria dell’Alto Adige-Comprensorio sanitario di Bolzano Bolzano Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Ospedale Vito Fazzi Lecce Lecce Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Sanitaria Locale Roma 2 Rome Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
ARNAS Garibaldi Di Catania Catania Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Azienda Ulss 3 Serenissima Venice Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Azienda Socio Sanitaria Territoriale Lariana Como Italy
Azienda Unita Sanitaria Locale Di Modena Carpi Italy
Azienda USL Toscana Sud Est Arezzo Italy
Azienda Sanitaria Locale Di Taranto Taranto Italy
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Universita’ Degli Studi Di Verona Verona Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Azienda USL Toscana Centro Prato Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Rome Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
IRCCS CROB Rionero In Vulture Italy
Azienda Ulss 6 Euganea Padua Italy
Ospedale “Umberto I” di Lugo Lugo Italy
Aopbjsy Ojcipoxzgmv Ukycxrrsnwntd Pjiph Parma Italy
Izafzq Iwkeuqgn Fxpjnitubicow Ocektemnqup Rome Italy
Aexsuka Ozsryrzggaf S Gktrduvn Aefdsajnmb Rome Italy
Ahutjhy Umi Txpstnw nwvc obdrh Leghorn Italy
Aeozsoq Osfnznnhhft Ruxshgcsn Sco Cvphc Potenza Italy
Agrerkt Uworw Lnhicn Sbejf Sawtujzek 1j Vraperjjr Venice Italy
Oknckpom Serfy Mftoa dibcv Cmkxc Ravenna Italy
Ajc Miqasqnb Macerata Italy
Ibldhiej Rznrsjwqz Pos Ld Shhwgx Dro Tlpsec Dknx Alvdtfv Illu Sxralf Meldola Italy
Axktjoe Oaycgrlfsyd Uewlgxtlbfehw Cokpvzrfuqhc Ddour Spqytr E Dyoyk Sqepfhx Db Taybqo Turin Italy
Amklkuc Ulz Iwaov Df Rablcy Erwdmi Reggio Emilia Italy
Aawtlvq Uttru Sbbxeqcvk Lavxyd Dw Bvqhrqw Bologna Italy
Acjjyrh Ohwcpbtkizb Peem Gqitnfqr Xnpvz Bergamo Italy
Atrrixy Sqjrfcdii Tgkhfgioetfi Poccro e Umhfwu (nkv Pkm Fano Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
17.06.2016

Trial locations

Investigated drugs:

Avelumab: Avelumab is a type of medication known as an anti-PD-L1 antibody. It is used in this clinical trial as an adjuvant treatment for patients with high-risk triple negative breast cancer. The goal of using Avelumab is to improve disease-free survival in patients who have already undergone surgery and chemotherapy. Avelumab works by helping the immune system recognize and attack cancer cells, potentially reducing the risk of cancer returning after initial treatment.

Investigated diseases:

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an X-ray. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. Triple-negative breast cancer is a subtype that lacks three common receptors known to fuel most breast cancer growths, making it more challenging to treat. This type of cancer is often more aggressive and has a higher chance of recurrence after initial treatment. Understanding the specific characteristics of the cancer is crucial for determining the best approach to management.

Trial ID:
2024-514515-10-00
Protocol code:
A-BRAVE-Trial
NCT ID:
NCT02926196
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study comparing datopotamab deruxtecan with durvalumab versus datopotamab deruxtecan alone for patients with PDL1-negative metastatic triple-negative breast cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • Study comparing datopotamab deruxtecan with or without durvalumab to chemotherapy with pembrolizumab for patients with triple-negative breast cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    France Italy Poland Spain