Atezolizumab With Nab-paclitaxel for Patients With Triple-negative Stage IV Breast Cancer — Anastase  

Breast Cancer Metastatic Clinical Trial

Official title: Atezolizumab in Combination With Nab-paclitaxel for Patients With Previously Untreated Metastatic Triple-negative Breast Cancer in a Real World Experience

Status Completed

Clinical Trial Summary

The study will evaluate the therapeutic efficacy of the association of Atezolizumab plus nabPaclitaxel in a real life context, in order to document any differences both in terms of activity and safety with respect to the knowledge of the association reported in the literature

Clinical Trial Description

On 8thMarch 8 2019, the Food and Drug Administration (FDA) granted accelerated approval to Atezolizumab in combination with nab-paclitaxel for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area). FDA also approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic device for selecting TNBC patients for atezolizumab. Approval was based on the clinical trial IMpassion130 results.

In EU, the Committee for Medicinal Products for Human Use (CHMP) issued positive opinion on 27thJune 2019 for the use of Atezolizumab 840 mg in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. Hereafter, the European Commission approved Atezolizumab for the treatment of mTNBC in August 2019.

In some cases, free access to pharmaceutical treatment is allowed in Italy before AIFA authorises its marketing or, for medicines already authorised, for indications other than those for which the medicinal product has been authorised in Italy (off-label use). One route for early access to a medicinal product is Compassionate use that involves direct and free delivery of the medicine by the manufacturer.

Due to the severity of the disease and the lack of further valid therapeutic alternatives, Roche S.p.A. in accordance with AIFA opened a Compassionate Use Program (CUP) based on the European indication mentioned above on 18th November 2019. The Program closed on 28th August 2020 following the approval and reimbursement granted by AIFA to Atezolizumab in mTNBC.

To date the drug is therefore available and reimbursed by the national health system, and has become part of daily clinical practice, as also indicated by the most recent AIOM guidelines.

Randomized controlled trials (RCTs) are trials in selected patients, they have a high internal validity but low external validity, their results could not extend to real word patient with different characteristics (patients in more severe or less severe clinical conditions, protected bands), there are a few data on interactions with concomitant diseases and therapies and on actual compliances with other therapies.

Real world evidence is important as it complements data from RCTs. After the pivotal trial, it is essential to continue studying the risk-benefit profile of the combination and therefore it is necessary carry out real world experience.

In the context of Compassionate Use Program a hundred patients have been treated with Atezolizumab plus nab-paclitaxel throughout Italy and it would be scientifically interesting to collect their data retrospectively as the first source of efficacy and safety of this combination in a real population. ;

Related Conditions & MeSH terms

• Breast Cancer Metastatic
• Breast Neoplasms

• NCT number: NCT05609903
• Study type: Observational
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Status: Completed
• Start date: November 1, 2019
• Completion date: May 31, 2022