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Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without atezolizumaB as first-line treatment in advanced triple negative Breast cancer
EU CTIS ID: 2024-516202-39-00
What this study is testing
Validate the BRCA1-like test in predicting differential progression free survival (PFS) according to RECIST v1.1 definitions for measurable and non-measurable disease with first line alkylating and platinum agents (± antibody add-on) when compared to paclitaxel (± antibody add-on) in TNBC
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed triple negative metastasized or locally advanced incurable breast cancer
- WHO performance status of 0 or 1
- Histological confirmation of triple negative breast cancer of a metastatic lesion is recommended
- Histological or cytological confirmation of metastatic breast cancer is required in case of normal CA 15.3 levels
- Primary tumor or metastasis tissue sent to NKI-AVL for BRCA1-like testing
- Pretreatment histological biopsy of a metastatic lesion for the translational research questions (tumor tissue from bone metastases cannot be used)
You likely can't join if
- Receptor conversion to hormone receptor positive (defined as ≥ 10% ER positive tumor cells) or HER2 positive
- Prior allogeneic stem cell or solid organ transplantation
- History of lung diseases such as idiopathic pulmonary fibrosis, pneumonitis
- An infection requiring parenteral antibiotic
- Positive test for hepatitis B, C or HIV
- Active tuberculosis
See the full eligibility criteria
- Histologically confirmed triple negative metastasized or locally advanced incurable breast cancer
- WHO performance status of 0 or 1
- Histological confirmation of triple negative breast cancer of a metastatic lesion is recommended
- Histological or cytological confirmation of metastatic breast cancer is required in case of normal CA 15.3 levels
- Primary tumor or metastasis tissue sent to NKI-AVL for BRCA1-like testing
- Pretreatment histological biopsy of a metastatic lesion for the translational research questions (tumor tissue from bone metastases cannot be used)
- No previous cytotoxic therapy for metastatic disease
- Disease-free interval of at least 12 months after completion of (neo)adjuvant paclitaxel or (neo)adjuvant platinum compound
- Disease-free interval of at least 6 months after completion of (neo) adjuvant docetaxel
- Measurable or evaluable disease according to RECIST V1.1
- Receptor conversion to hormone receptor positive (defined as ≥ 10% ER positive tumor cells) or HER2 positive
- Prior allogeneic stem cell or solid organ transplantation
- History of lung diseases such as idiopathic pulmonary fibrosis, pneumonitis
- An infection requiring parenteral antibiotic
- Positive test for hepatitis B, C or HIV
- Active tuberculosis
- Live, attenuated vaccine within 4 weeks prior to randomization
- Prior treatment with anti cancer vaccins or immune checkpoint blockade therapies, including anti-CTLA-4, CD137 agonist, OX40 agonist, anti-PD-1, or anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents, systemic corticosteroids or other systemic immunosuppressive medications
- Other antitumor therapy within the previous 21 days, with the exception of endocrine therapy. The patient should have stopped any endocrine therapy before start study treatment.
- Radiotherapy with palliative intent within the previous 7 days before start study medication
- Known CNS disease except for treated brain metastases
- Pre-existing peripheral neuropathy > grade 1 (NCI-CTC AE (version 4.03) at inclusion)
- Use of denosumab is not allowed
- Severe infection in the last 4 weeks
- Antibiotics in the last 2 weeks
- History of autoimmune disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.