Examining Tissue Immune Profiles in Patients with Metastatic Triple-negative Breast Cancer

Evaluation of a Tissue Immune Profile (TIP) in Patients Affected by Metastatic TNBC Treated With Upfront Atezolizumab Plus Nab-paclitaxel (TIP)

This study is testing how the immune system in patients with advanced triple-negative breast cancer responds to a combination of a specific drug and chemotherapy to find better treatment options.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione per la Medicina Personalizzata (Academic / other)
• Drugs / interventions: atezolizumab, chemotherapy, Immunotherapy
• Locations: 6 sites (Prato, FI and 5 other locations)
• Trial ID: NCT05831553 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with metastatic triple-negative breast cancer (TNBC) who are PD-L1 positive. It aims to analyze tissue immune profiles to identify new molecular targets and therapeutic strategies, particularly in the context of immunotherapy combined with chemotherapy. Participants must have a confirmed diagnosis and be eligible for treatment with atezolizumab plus nab-paclitaxel. The study will collect clinical data on treatment duration, efficacy, and safety to better understand the immune response in TNBC.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed PD-L1 positive metastatic TNBC who can provide informed consent.

Not a fit: Patients who are unable to provide informed consent or have conditions that may hinder compliance with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with metastatic TNBC, enhancing their outcomes.

How similar studies have performed: Other studies have shown success with similar approaches in utilizing immunotherapy for metastatic TNBC, indicating a promising avenue for further exploration.

Eligibility criteria

Inclusion Criteria:

* Patients able and willing to provide a written informed consent to participate to the study;
* Histological confirmed diagnosis of PD-L1 positive TNBC (\> 1%)
* Confirmed radiological or histological diagnosis of metastatic TNBC
* Availability of tumor specimen in order to perform the requested analysis
* Patients eligible for or treated with atezolizumab plus nab-paclitaxel first line as requested for clinical practice
* Availability of complete clinical data on duration, efficacy and safety of the treatment

Exclusion Criteria:

* Sample not sufficient to perform the requested tissue analysis
* Patients unable to provide informed consent or with possible poor compliance with protocol procedures
* Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
* Patients treated with the following drugs, because of the risk of immunosuppression: Chronic or high-dose oral corticosteroid therapy, TNF-inhibitors and Anti-T cell antibodies
* Patients participating in other clinical studies.

Where this trial is running

Prato, FI and 5 other locations

• Ospedale Santo Stefano — Prato, Fi, Italy (Recruiting)
• IRCCS Istituto Europeo di Oncologia IEO — Milano, Mi, Italy (Suspended)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
• Azienda Ospedaliero Universitaria Policlinico Umberto I — Roma, Rm, Italy (Recruiting)
• ospedale Belcolle — Viterbo, Vt, Italy (Not_yet_recruiting)
• Istituto Nazionale per lo Studio e la Cura dei Tumori - Fondazione S. Pascale — Napoli, Italy (Recruiting)

Study contacts

• Study coordinator: Paolo Marchetti

Conditions Metastatic Triple-negative Breast Cancer