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New treatment option for Triple Negative Breast Cancer
Official title Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients
ClinicalTrials.gov ID: NCT06690840
What this study is testing
What is Atezolizumab in combination with Cyclophosphamide and Vinorelbine?
Atezolizumab in combination with Cyclophosphamide and Vinorelbine is an investigational medicine, being studied as a potential treatment for triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Triple-negative breast cancer (TNBC) is among the most aggressive and lethal types of breast cancer, and currently available therapies have an unsatisfactory impact on patients' survival. The primary aim of this clinical trial is to evaluate efficacy in terms of Overall Response Rate (ORR) of atezolizumab plus cyclophosphamide and vinorelbine in first line patients with unresectable locally advanced or metastatic TNBC patients, previously treated with anti-programmed cell death ligand-1 (PD-L1) or anti-programmed cell death-1 (PD-1) - containing regimens, in the neoadjuvant/adjuvant setting.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed Informed Consent Form
- Patients with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor 2 [HER2], estrogen receptor...
- Locally advanced or metastatic TNBC, who have received an anti-PD-1/PD-L1 containing regimen in the neoadjuvant/adjuvant setting
- No prior chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy for inoperable locally advanced or metastatic TNBC
- Tissue accessible for biopsies
You likely can't join if
- Patients with de novo metastatic TNBC OR those who have received 1 or more chemotherapy or targeted systemic therapy (including endocrine therapy) or...
- Immunodeficiency or systemic steroid therapy/immunosuppressive therapy within 7 days prior to study entry
- Known history of active Bacillus Tuberculosis (TBC)
- Hypersensitivity to anti- PD-L1 antibodies or its excipients
- Active autoimmune disease
- Known history of non-infectious pneumonitis
See the full eligibility criteria
- Signed Informed Consent Form
- Patients with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PR] expression) PD-L1+ (Immune Cell...
- Locally advanced or metastatic TNBC, who have received an anti-PD-1/PD-L1 containing regimen in the neoadjuvant/adjuvant setting
- No prior chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy for inoperable locally advanced or metastatic TNBC
- Tissue accessible for biopsies
- Expected survival of \> 3 months
- Female or male subject ≥18 years
- Have measurable/evaluable metastatic disease (RECIST 1.1 criteria)
- Performance status 0-1 on Eastern Cooperative Oncology Group Performance Status (ECOG PS)
- Demonstrate adequate organ (kidney, liver) function
- Patients with de novo metastatic TNBC OR those who have received 1 or more chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy regimens for advanced disease
- Immunodeficiency or systemic steroid therapy/immunosuppressive therapy within 7 days prior to study entry
- Known history of active Bacillus Tuberculosis (TBC)
- Hypersensitivity to anti- PD-L1 antibodies or its excipients
- Active autoimmune disease
- Known history of non-infectious pneumonitis
- Active infection requiring systemic therapy
- Known history of Human Immunodeficiency Virus (HIV)
- Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative])
- Live vaccine within 30 days
- Bone or brain metastases
The study team makes the final eligibility decision.
Where it's taking place
- Monza, Monza, Italy
- Roma, Roma, Italy
- Brindisi, Italy
- Milan, Italy
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monza, Monza, Italy; Roma, Roma, Italy; Brindisi, Italy; Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.