Breast cancer treatment study: Dato-DXd and durvalumab

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    What is this study about?

    This clinical trial is a comprehensive study aimed at evaluating the effectiveness and safety of advanced treatments for breast cancer, specifically targeting triple-negative and hormone receptor-low/HER2-negative types. The study involves two groups of participants. One group will receive a combination of Dato-DXd and durvalumab as a neoadjuvant (pre-surgery) treatment, followed by durvalumab as an adjuvant (post-surgery) therapy, with or without additional chemotherapy. The other group will be treated with pembrolizumab plus chemotherapy as both neoadjuvant and adjuvant therapies. The goal is to see which method is better at treating the cancer. Additional objectives include evaluating overall survival, distant disease-free survival, and participant-reported outcomes related to symptoms, physical function, fatigue, and quality of life.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Feldkirch , Austria

      Graz , Austria

      Innsbruck , Austria

      Linz , Austria

      Salzburg , Austria

      Brasschaat , Belgium

      Charleroi , Belgium

      Gent , Belgium

      Leuven , Belgium

      Libramont-Chevigny , Belgium

      Wilrijk , Belgium

      Plovdiv , Bulgaria

      Shumen , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Vratza , Bulgaria

      Avignon , France

      Bayonne , France

      Caen Cedex 5 , France

      Clermont Ferrand , France

      Limoges , France

      Lyon , France

      Marseille , France

      Montpellier , France

      Nice , France

      Paris , France

      Reims Cedex , France

      Saint Herblain , France

      Toulouse , France

      Vandoeuvre les Nancy , France

      Villejuif Cedex , France

      Augsburg , Germany

      Berlin , Germany

      Berlin , Germany

      Dessau-Rou00dflau , Germany

      Dresden , Germany

      Erlangen , Germany

      Essen , Germany

      Esslingen am Neckar , Germany

      Frankfurt am Main , Germany

      Freiburg , Germany

      Hannover , Germany

      Hannover , Germany

      Heidelberg , Germany

      Kiel , Germany

      Mainz , Germany

      Mannheim , Germany

      Mu00fcnchen , Germany

      Mu00fcnster , Germany

      Trier , Germany

      Ulm , Germany

      Budapest , Hungary

      Kecskemu00e9t , Hungary

      Miskolc , Hungary

      Nyu00edregyhu00e1za , Hungary

      Salgu00f3tarju00e1n , Hungary

      Szekszu00e1rd , Hungary

      Empoli , Italy

      Lucca , Italy

      Macerata , Italy

      Milano , Italy

      Modena , Italy

      Napoli , Italy

      Padova , Italy

      Roma , Italy

      Rozzano , Italy

      Torino , Italy

      Tricase , Italy

      Udine , Italy

      Barcelona , Spain

      Barcelona , Spain

      Granada , Spain

      Hospitalet deLlobregat , Spain

      Madrid , Spain

      Madrid , Spain

      Santiago de Compostela , Spain

      Sevilla , Spain

      Zaragoza , Spain

      Birmingham , United Kingdom

      Cardiff , United Kingdom

      Edinburgh , United Kingdom

      Guildford , United Kingdom

      Lancaster , United Kingdom

      London , United Kingdom

      Northampton , United Kingdom

      Oxford , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Hello, I see you have questions regarding the clinical trial NCT06112379. The trial information is quite extensive; please let me know your specific questions, and I will find the answers for you based on the trial documentation provided.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria in the clinical trial information, to join this study you need to have one of the following diseases:

      • Stage II or III unilateral or bilateral primary invasive triple-negative breast cancer (TNBC)
      • Stage II or III unilateral or bilateral primary invasive hormone receptor-low/HER2-negative breast cancer

      The study is specifically for patients with these types and stages of breast cancer. No other diseases are mentioned as requirements to participate in the trial.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      1. Participant must be ≥ 18 years, at the time of signing the Informed Consent Form (ICF).
      2. Histologically confirmed Stage II or III unilateral or bilateral primary invasive Triple-Negative Breast Cancer (TNBC) or hormone receptor-low/HER2-negative breast cancer. Histologically confirmed means the presence of cancer has been confirmed by microscopic examination of tissue. Stage II or III refers to the size and extent of the cancer, with Stage II being a more advanced stage than Stage I, but not as advanced as Stage III. Unilateral or bilateral primary invasive indicates that the cancer is original (not metastatic) and is present in either one (unilateral) or both (bilateral) breasts. TNBC refers to a type of breast cancer that does not have receptors for estrogen, progesterone, or HER2/neu proteins. Hormone receptor-low means that the cancer cells have fewer hormone receptors than normal. HER2-negative means that the cancer cells do not have excess amounts of the HER2 protein on their surface.
      3. ECOG Performance Status (PS) of 0 or 1. The ECOG Performance Status is a scale used to assess how a patient’s disease is progressing, how the disease affects the daily living abilities of the patient, and helps to determine appropriate treatment and prognosis. A score of 0 indicates fully active, able to carry on all pre-disease performance without restriction; a score of 1 indicates restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
      4. Provision of an acceptable tumor sample for the study. This is a requirement for the study to analyze and confirm the type of breast cancer.
      5. Adequate bone marrow reserve and organ function. This means that the participant’s bone marrow and organs are functioning well enough to support the participant through the study treatments.
      6. Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. This indicates that men and women must agree to use acceptable methods of birth control to prevent pregnancy during the study, according to local government regulations.

      Please, let me know if you need further details about the clinical trial or any additional information.

      What Reasons Could Exclude Me from the Study?

      I have access to the clinical trial document. Please go ahead and ask me any questions you have about the trial, and I’ll do my best to provide you with the information you need.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The following drugs are involved in this phase 3 breast cancer study:

      • Datopotamab deruxtecan (Dato-DXd, DS-1062a): An experimental antibody-drug conjugate targeting TROP2, given as an IV infusion in the study arm.
      • Durvalumab (MEDI4736): An experimental PD-L1 immune checkpoint inhibitor, given as an IV infusion in combination with Dato-DXd in the study arm.
      • Pembrolizumab (KEYTRUDA): PD-1 immune checkpoint inhibitor, given as an IV infusion in the control arm in combination with chemotherapy.
      • Doxorubicin: Chemotherapy drug, may be given as an IV infusion in both the study and control arms.
      • Epirubicin: Chemotherapy drug, may be given as an IV infusion in both the study and control arms.
      • Cyclophosphamide: Chemotherapy drug, given as an IV infusion in both the study and control arms.
      • Paclitaxel: Chemotherapy drug, given as an IV infusion in both the study and control arms.
      • Carboplatin: Chemotherapy drug, given as an IV infusion in both the study and control arms.
      • Capecitabine (XELODA): Chemotherapy drug, given as oral tablets in both the study and control arms for participants with residual disease.
      • Olaparib (LYNPARZA): PARP inhibitor, given as oral tablets in both the study and control arms for participants with gBRCA-positive tumors and residual disease.

      The study compares the experimental combination of Dato-DXd + durvalumab vs. the control treatment of pembrolizumab + chemotherapy. Dato-DXd and durvalumab are given before surgery (neoadjuvant), while pembrolizumab and chemo are given both before and after surgery (neoadjuvant and adjuvant). The chemo drugs and olaparib may be given after surgery depending on response and genetic factors.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Based on the information provided about the clinical trial, here is a list of the active substances and whether they are already known to medicine and medical literature:

      1. Datopotamab deruxtecan (Dato-DXd, DS-1062a): An experimental drug, so it is likely not well established in medical literature yet as it is still being researched in clinical trials.
      2. Durvalumab (MEDI4736): Yes, durvalumab is an established medication. It is a type of immunotherapy drug known as an immune checkpoint inhibitor and is approved to treat some types of lung and bladder cancers.
      3. Pembrolizumab (Keytruda): Yes, pembrolizumab is a well known medication. It is another immune checkpoint inhibitor drug approved to treat various types of cancer including melanoma, lung cancer, head and neck cancer, Hodgkin’s lymphoma, and stomach cancer.
      4. Doxorubicin: Yes, a very well established chemotherapy drug that has been used for decades to treat many types of cancer.
      5. Epirubicin: Yes, an established chemotherapy medication closely related to doxorubicin, used to treat breast cancer and some other cancers.
      6. Cyclophosphamide: Yes, a well known chemotherapy agent that has been in use for a long time to treat cancers and some autoimmune disorders.
      7. Paclitaxel: Yes, paclitaxel is a widely used and well established chemotherapy drug to treat many types of cancer.
      8. Carboplatin: Yes, a very common chemotherapy medication used to treat various cancers for many years.
      9. Capecitabine (Xeloda): Yes, capecitabine is an established oral chemotherapy drug used for breast and colorectal cancers. It is a prodrug that gets converted to 5-fluorouracil in the body.
      10. Olaparib (Lynparza): Yes, olaparib is known in medical literature and clinical practice. It is a targeted therapy called a PARP inhibitor used to treat some ovarian, breast, and prostate cancers.

      Study ID

      CT-EU-00033185

      Recruitment status

      Recruting new patients

      Start of the trial

      7 months ago