UnknownPhase 2

Atezolizumab Plus CArboplatin Plus Nab-paclitaxel

Italy49 participantsStarted 2020-07-03

Plain-language summary

Primary objective: To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients as evaluated by % 2years OS. Secondary objective: * To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of % OS at 2.5 years * To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of % OS at 2 years in hormonal receptor (HR) between 1% and 10% * To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of post-progression survival * To assess the activity of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients in terms of ORR, and time to treatment failure * To assess the safety of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients Exploratory Objectives: Exploratory objectives will be focused on the assessment of both tumor-centered characteristics through the NGS analysis of circulating tumor DNA (ctDNA) and immune-centric features through the evaluation of a multiparametric Cancer agnostic circuLating ImmunOsignature (CLIO): * To assess the association between patients' characteristics, treatment activity, efficacy and safety and through a CLIO in metastatic triple-negative breast cancer patients receiving atezolizumab plus carboplatin plus paclitaxel as first-line therapy * To explore the association between the CLIO and treatment activity, efficacy and safety * To explore the dynamics of circulating tumor DNA (ctDNA) levels and detectable aberrations with respect to treatment activity and efficacy Concomitant timepoints will not be used for cross-validations between the two methodologies.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed Informed Consent Form
✓. Women or men aged ≥18 years
✓. Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic disease
✓. Hormone receptor-negative (ER and PgR \< 10%) and HER2-negative (IHC 0,1+ or 2+ ISH not amplified) breast cancer, based on the status of the primary tumor and/or the biopsy of metastatic disease before starting first-line therapy and assessed by local laboratory.
✓. Patients ER and PgR \< 1% eligible to receive atezolizumab in combination with nab-paclitaxel as standard of care treatment for metastatic triple-negative breast cancer (TNBC), regardless of study participation.
✓. PD-L1 positive defined as expression on tumor-infiltrating immune cells ≥1% (SP142 PD-L1 immunohistochemical assay, Ventana Medical Systems), based on the status of the primary tumor and/or the biopsy of metastatic disease before starting first-line therapy and assessed by local laboratory
✓. Availability of a representative tumor specimen for translational research
✓. Eligible for first-line taxane and carboplatin chemotherapy

Exclusion criteria

What they're measuring

Overall survival

Timeframe: 2 years

Trial details

NCT IDNCT05266937

SponsorConsorzio Oncotech

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-03

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