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Ongoing Clinical Trials for Triple Negative Breast Cancer

This article provides comprehensive information about 54 ongoing clinical trials investigating new treatments for triple negative breast cancer, a type of breast cancer that lacks estrogen, progesterone, and HER2 receptors. These trials are testing various therapeutic approaches including immunotherapy, targeted therapies, chemotherapy combinations, and novel drug candidates across multiple countries worldwide.

Clinical trial locations

Evaluating sacituzumab tirumotecan alone or with pembrolizumab compared to standard treatment in untreated patients with metastatic triple-negative breast cancer with low PD-L1 expression

This trial is testing sacituzumab tirumotecan (also known as MK-2870) as a treatment for patients whose cancer has spread and who have not yet received treatment for their metastatic disease. The study compares this medication given alone or with pembrolizumab (KEYTRUDA) against standard chemotherapy options.

Main inclusion criteria: Patients must have metastatic triple-negative breast cancer that cannot be surgically removed. They should not have received previous treatment for advanced disease, though prior treatment for early-stage cancer is allowed if completed at least 6 months before the cancer returned. The cancer must show PD-L1 expression below a CPS score of 10.

Main exclusion criteria: Patients who have already received pembrolizumab or have active brain metastases that are not stable cannot participate. Those with active autoimmune disease requiring treatment or who received live vaccines within 30 days before starting are also excluded.

Study focus: The trial aims to determine if sacituzumab tirumotecan works better than standard chemotherapy, both when given alone and when combined with pembrolizumab. Researchers will monitor tumor response and track how long patients live without disease progression.

Investigational drugs: Sacituzumab tirumotecan is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells by targeting the Trop-2 protein. Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein. The physician’s choice treatment options include standard chemotherapy drugs like paclitaxel, albumin-bound paclitaxel, or combinations of gemcitabine with carboplatin.

Study Comparing Sacituzumab Govitecan Alone and with Pembrolizumab for Patients with Low-Risk, Triple-Negative Early Breast Cancer

This study evaluates sacituzumab govitecan as a treatment before surgery for early-stage triple-negative breast cancer that is considered low-risk. The trial compares treatment with sacituzumab govitecan alone versus the same medication combined with pembrolizumab.

Main inclusion criteria: Patients must have triple-negative breast cancer that has not spread to other parts of the body. The tumor must be between 2-5 cm in size, or smaller with lymph node involvement. Participants must have good physical function and adequate organ and bone marrow function.

Main exclusion criteria: The specific exclusion criteria are not detailed in the provided data, but generally patients with other medical conditions, those outside the age range, and those not meeting the study requirements would be excluded.

Study focus: The research aims to determine if adding pembrolizumab to sacituzumab govitecan improves the complete response rate after treatment but before surgery. The study will track whether adding immunotherapy to the antibody-drug conjugate leads to better outcomes in eliminating cancer cells.

Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that targets the Trop-2 protein found on cancer cells to deliver chemotherapy directly to tumors. Pembrolizumab is an immunotherapy medication that blocks the PD-1 pathway, helping the immune system better recognize and attack cancer cells.

Study of Atezolizumab, Vinorelbine, and Cyclophosphamide for Patients with Advanced Triple Negative Breast Cancer Previously Treated with Anti-PD-L1/PD-1

This trial investigates whether the combination of atezolizumab with vinorelbine and cyclophosphamide can activate immune cells in patients who have already received anti-PD-L1/PD-1 treatment for advanced triple-negative breast cancer.

Main inclusion criteria: Patients must have metastatic triple-negative breast cancer that cannot be removed by surgery. They should have been previously treated with anti-PD-L1/PD-1 medications and have at least one prior treatment for their advanced cancer. The tumor must show PD-L1 positivity, and patients need to have a life expectancy of at least 12 weeks.

Main exclusion criteria: Patients with brain metastases that are not stable, severe liver disease, or uncontrolled diabetes cannot participate. Those who are pregnant or breastfeeding, or who have active infections are also excluded.

Study focus: The research evaluates whether this three-drug combination can reactivate the immune system in patients whose cancer has already been exposed to immunotherapy. The study will measure immune cell activation within tumors and assess clinical responses.

Investigational drugs: Atezolizumab is an immunotherapy that blocks the PD-L1 protein, helping immune cells attack cancer. Vinorelbine is a chemotherapy drug that stops cancer cells from dividing and growing. Cyclophosphamide is another chemotherapy agent that damages cancer cell DNA to prevent multiplication.

Study of Bicalutamide and Abemaciclib for Patients with Advanced Androgen Receptor Positive Triple-Negative Breast Cancer

This study tests the combination of bicalutamide, an antiandrogen medication, with abemaciclib, a CDK 4/6 inhibitor, for patients with advanced androgen receptor positive triple-negative breast cancer.

Main inclusion criteria: Patients must have triple-negative breast cancer that is positive for androgen receptors and either cannot be removed by surgery or has spread to other parts of the body. They should be eligible to receive gemcitabine and carboplatin as their next treatment line, with no more than one previous treatment for advanced disease.

Main exclusion criteria: Patients who have received prior PARP inhibitor treatment, have active brain metastases, or are pregnant or breastfeeding cannot participate. Those with severe autoimmune disease or major surgery within 4 weeks are also excluded.

Study focus: The trial aims to determine the disease control rate at 16 weeks when using this combination therapy. Researchers will evaluate how well the treatment controls cancer growth and assess various measures of treatment effectiveness including response duration and overall survival.

Investigational drugs: Bicalutamide blocks the effects of androgens (male hormones) that can promote cancer growth in this specific subtype of triple-negative breast cancer. Abemaciclib is a CDK 4/6 inhibitor that helps stop cancer cells from dividing by interfering with proteins essential for cell division.

Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer

This trial evaluates BT-001, administered directly into tumors, both alone and in combination with pembrolizumab immunotherapy for various advanced cancers including triple-negative breast cancer.

Main inclusion criteria: Patients must be 18 years or older with confirmed advanced cancer including triple-negative breast cancer that has either progressed despite standard treatment, cannot tolerate standard treatment, or for which no standard treatment exists. Patients must have at least one tumor that can be injected and must have completed COVID-19 vaccination at least 30 days before treatment.

Main exclusion criteria: Patients who have received other cancer treatment within 21 days, have uncontrolled infections, severe claustrophobia preventing imaging, or are pregnant or breastfeeding cannot participate. Those with severe kidney or liver problems are also excluded.

Study focus: The study investigates whether injecting BT-001 directly into tumors can activate the immune system to fight cancer, particularly when combined with pembrolizumab. Researchers will evaluate both local effects at the injection site and overall effects on the body.

Investigational drugs: BT-001 is an oncolytic immunotherapy that uses a virus to infect and kill cancer cells while stimulating immune response. Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells by blocking the PD-1 protein.

Study of BT8009 for Patients with Advanced Breast Cancer with NECTIN4 Amplification

This trial studies zelenectide pevedotin (BT8009) for patients with advanced breast cancer whose tumors have high levels of the NECTIN4 protein, including some cases of triple-negative breast cancer.

Main inclusion criteria: Patients must be 18 years or older with confirmed breast cancer that has spread or cannot be removed surgically. The cancer must show NECTIN4 gene amplification through specific testing. Patients need at least one measurable tumor and must have adequate organ function including heart function of 50% or better.

Main exclusion criteria: Patients who have received platinum-based chemotherapy within the last 4 weeks, have serious heart conditions, uncontrolled infections, or are pregnant or breastfeeding cannot participate. Those with known allergies to the study medication are also excluded.

Study focus: The research evaluates how effective BT8009 is in shrinking tumors or stopping their growth in patients with NECTIN4-amplified breast cancer. The study will measure tumor response and monitor for any side effects during treatment.

Investigational drugs: Zelenectide pevedotin is an antibody-drug conjugate that specifically targets the NECTIN4 protein on cancer cells, delivering a potent anti-cancer drug directly to tumor cells while limiting damage to healthy cells.

Study of Capecitabine and Pembrolizumab for Patients with Triple Negative Breast Cancer After Chemoimmunotherapy and Surgery

This study evaluates whether continuing treatment with capecitabine and pembrolizumab after surgery improves outcomes for triple-negative breast cancer patients who have residual disease despite initial chemotherapy and immunotherapy.

Main inclusion criteria: Patients must have completed at least 6 cycles of standard chemotherapy including pembrolizumab before surgery and have remaining cancer in the breast or lymph nodes after surgery. They must have adequate organ and bone marrow function and be within 12 weeks of final surgery or 10 weeks of completing radiation therapy.

Main exclusion criteria: Patients who achieved complete response (no remaining cancer) after initial treatment, are pregnant or breastfeeding, have other active cancers, or serious infections are excluded. Those with severe autoimmune disease or who received live vaccines recently cannot participate.

Study focus: The trial investigates whether adding capecitabine chemotherapy to pembrolizumab immunotherapy after surgery can prevent cancer from returning in patients who still had cancer remaining despite pre-surgery treatment. The study will track disease-free survival and overall survival.

Investigational drugs: Capecitabine is an oral chemotherapy drug that interferes with cancer cell DNA to slow their growth and spread. Pembrolizumab is an immunotherapy that blocks the PD-1 pathway, helping the immune system better recognize and attack cancer cells.

Study of Datopotamab Deruxtecan for Patients with Triple-Negative Breast Cancer and New or Worsening Brain Metastases

This trial investigates datopotamab deruxtecan (Dato-DXd) for patients whose triple-negative breast cancer has spread to the brain or whose brain metastases are getting worse after previous treatment.

Main inclusion criteria: Patients must have confirmed triple-negative breast cancer with newly diagnosed brain metastases that have not been treated, or brain metastases that are worsening after treatment. They must have measurable disease in the brain and no need for immediate local treatment of the brain metastases. Patients need a Karnofsky Performance Status of 70% or higher and adequate organ function.

Main exclusion criteria: Patients who are pregnant or breastfeeding, have had recent major surgery, or are participating in another clinical trial cannot join. Those with severe infections or a history of allergic reactions to similar medications are also excluded.

Study focus: The research aims to determine if Dato-DXd can reduce or control brain metastases in triple-negative breast cancer patients. The study will assess tumor response in both the brain and other parts of the body, as well as overall and progression-free survival.

Investigational drugs: Datopotamab deruxtecan is an antibody-drug conjugate that targets the Trop-2 protein on cancer cells, delivering a cytotoxic agent directly to tumors while potentially minimizing damage to healthy tissue.

Study of IMC-F106C alone and with checkpoint inhibitors in patients with advanced PRAME-positive cancers who have HLA-A*02:01

This trial tests IMC-F106C (brenetafusp), a novel immunotherapy, both alone and combined with checkpoint inhibitors for patients with advanced cancers that express PRAME protein, including triple-negative breast cancer.

Main inclusion criteria: Patients must be 18 years or older and have cancer that is HLA-A*02:01 positive and PRAME-positive. The cancer should have either returned after previous treatment, not responded to standard treatments, or the patient cannot tolerate standard treatments. Patients need an ECOG performance status of 0 or 1.

Main exclusion criteria: Patients who have received prior PRAME-targeted therapy, have active or untreated brain metastases, severe allergic reactions to antibody treatments, significant heart problems, or active uncontrolled infections cannot participate. Those who are pregnant or breastfeeding are also excluded.

Study focus: The study aims to determine the safety and optimal dosing of IMC-F106C when given alone or with other cancer treatments. The trial will evaluate how well the treatment works in Phase 2 by measuring tumor response and various survival outcomes.

Investigational drugs: IMC-F106C is an investigational immunotherapy designed to target PRAME-positive cancer cells in patients with a specific genetic marker (HLA-A*02:01), helping the immune system recognize and attack these cancer cells.

Study of Patritumab Deruxtecan and Pembrolizumab for Patients with High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive Breast Cancer

This study compares patritumab deruxtecan (MK-1022) with pembrolizumab against standard chemotherapy with pembrolizumab for high-risk early-stage triple-negative or hormone receptor-low positive breast cancer before and after surgery.

Main inclusion criteria: Patients must have locally advanced, non-metastatic breast cancer that is either triple-negative or hormone receptor-low positive/HER2-negative. The tumor must be Stage II or III, and patients need an ECOG Performance Status of 0 to 1 with adequate bone marrow reserve and organ function. A left ventricular ejection fraction of 50% or higher is required.

Main exclusion criteria: Patients with a history of severe allergic reactions to study drugs, who received other cancer treatment within the last 4 weeks, have uncontrolled illnesses, are pregnant or breastfeeding, or have active infections are excluded. Those with brain metastases or autoimmune diseases are also excluded.

Study focus: The trial investigates whether the combination of patritumab deruxtecan and pembrolizumab is more effective than standard chemotherapy with pembrolizumab in achieving complete response after treatment and surgery. The study will track both before-surgery and after-surgery treatment phases.

Investigational drugs: Patritumab deruxtecan is a targeted therapy that attaches to the HER3 protein on cancer cells and delivers an anti-cancer drug directly to them. Pembrolizumab is an immunotherapy that blocks the PD-1 protein, helping the immune system recognize and attack cancer cells.

Study of Pembrolizumab, Carboplatin, and Paclitaxel for Patients with Stage I Triple-Negative Breast Cancer

This trial evaluates the combination of pembrolizumab immunotherapy with carboplatin and paclitaxel chemotherapy for patients with early-stage triple-negative breast cancer before surgery.

Main inclusion criteria: Patients must have Stage I triple-negative breast cancer with tumor size between 10-20 mm or up to 25 mm if measured after biopsy. The cancer should not have spread to lymph nodes. Patients need adequate bone marrow, liver, and kidney function and an ECOG performance status of 0-1.

Main exclusion criteria: Patients who have received previous treatment for their cancer, have serious heart conditions, uncontrolled infections, are pregnant or breastfeeding, or have known brain metastases cannot participate. Those with autoimmune diseases or who received live vaccines within 30 days are also excluded.

Study focus: The research aims to determine how effectively this three-drug combination can eliminate cancer cells before surgery, as measured by the absence of invasive cancer in the breast and lymph nodes after treatment.

Investigational drugs: Pembrolizumab helps the immune system fight cancer by blocking the PD-1 protein. Carboplatin damages cancer cell DNA to prevent their growth. Paclitaxel interferes with cell division by stabilizing microtubules, stopping cancer cells from dividing.

Summary

These ongoing clinical trials represent diverse approaches to treating triple-negative breast cancer across various stages of disease. The trials are being conducted in multiple European countries including Belgium, France, Germany, Italy, Spain, and several others, reflecting significant international collaboration in cancer research.

Several notable patterns emerge from these trials. Immunotherapy combinations, particularly involving pembrolizumab (Keytruda), appear in numerous studies, often combined with chemotherapy or novel targeted agents. Antibody-drug conjugates like sacituzumab govitecan, sacituzumab tirumotecan, and datopotamab deruxtecan feature prominently, representing a growing focus on targeted drug delivery approaches.

The trials address triple-negative breast cancer at different stages, from early-stage disease receiving treatment before surgery (neoadjuvant) to advanced metastatic disease. Many studies specifically focus on patients who have not responded to standard treatments or who have high-risk features, reflecting efforts to improve outcomes for the most challenging cases.

Geographic concentration is particularly notable in major cancer research centers across France, Germany, Italy, and Spain, with many multicenter trials spanning multiple countries. This international collaboration enables larger patient populations and more robust data collection.

Ongoing Clinical Trials on Triple negative breast cancer

  • 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
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    Investigated drugs:
    Germany Spain

  • Study on Atorvastatin’s Role in Enhancing Immunotherapy for Patients with Triple Negative Breast Cancer and Non-Small Cell Lung Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Patritumab Deruxtecan and Pembrolizumab for Patients with High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of [68Ga]Ga-PentixaFor PET-CT Imaging in Patients with Metastatic Triple-Negative Breast Cancer

    Recruiting

    1 1
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    Investigated drugs:
    France

  • Study on Pembrolizumab for Patients with Early Triple-Negative Breast Cancer Responding Well to Initial Treatment

    Recruiting

    1 1 1 1
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    Investigated drugs:
    Belgium France

  • Study of Atezolizumab, Carboplatin, and Nab-Paclitaxel for Patients with Metastatic Triple-Negative PD-L1 Positive Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Datopotamab Deruxtecan for Patients with Triple-Negative Breast Cancer and New or Worsening Brain Metastases

    Recruiting

    1 1
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    Investigated drugs:
    Austria Ireland

  • Study on NECVAX-NEO1 and Paclitaxel Albumin-Bound for Patients with Triple-Negative Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Atezolizumab, Vinorelbine, and Cyclophosphamide for Patients with Advanced Triple Negative Breast Cancer Previously Treated with Anti-PD-L1/PD-1

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Capecitabine and Pembrolizumab for Patients with Triple Negative Breast Cancer After Chemoimmunotherapy and Surgery

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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