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

NCT05609903 | Completed

• 1 other identifier: ID4060
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer Metastatic

Keywords

Atezolizumab; Nab-Paclitaxel, Metastatic Breast Cancer;

Outcome Measures

Primary Outcomes (2)

• Objective responce rate

  Rate of patients with a partial responce or stable disease

  1 year

• Time-to-treatment discontinuation

  Time from tha start of therapy to the time of treatment discontinuation for any reason

  1 year

Interventions

Atezolizumab in combination with nab-paclitaxel DRUG

Treatment of patients with stage IV triple negative breast cancer with Atezolizumab in combination with nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged ≥ 18 with biopsy proven Triple Negative Breast Cancer locally advanced or stage IV at diagnosis.

You may qualify if:

• Women aged ≥ 18 years who have provided written informed consent
• Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
• No prior chemotherapy, experimental or targeted systemic therapy for inoperable locally advanced or metastatic TNBC. Prior chemotherapy (including taxanes) in the neoadjuvant or adjuvant setting is allowable if treatment was completed ≥12 months prior to enter the compassionate use program
• PD-L1-positive tumour status defined as PD-L1 expression ≥1% on tumour-infiltrating immune cells as percentage per tumour area, assessed by the Ventana PD-L1 (SP142) assay based on the status of the primary tumor and/or the biopsy of metastatic disease before starting the treatment. Samples should be assessed by a qualified laboratory and different assays are not acceptable
• Patients eligible for ongoing atezolizumab clinical trials from which they may benefit are excluded
• Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
• ECOG performance status of 0 or 1
• Life expectancy ≥ 12 weeks
• Measurable disease, as defined by RECIST v1.1
• Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1)
• ANC ≥1500 cells/µL (without granulocyte colony-stimulating factor \[G-CSF\] support within 2 weeks prior to Cycle 1, Day 1);
• Lymphocyte count ≥500/µL; Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1);
• Hemoglobin ≥9.0 g/dL; AST, ALT, and alkaline phosphatase ≤2.5x the upper limit of normal (ULN), with the following exceptions:
• Patients with documented liver metastases: AST and ALT ≤5x ULN
• Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5x ULN

You may not qualify if:

• Women of child bearing potential must agree to either use a contraceptive method with a failure rate of ≤ 1% per year or to remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 5 months after the last dose of atezolizumab or 1 month after the last dose of nab-paclitaxel, whichever is later. For definition of postmenopausal status see the study protocol
• Women of child bearing potential must have a negative serum pregnancy test result prior to start the treatment
• Esclusion Criteria:
• Patients who have not completed 1 cycle of treatment

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico A. Gemelli - IRCCS

Roma, RM, 00167, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

atezolizumab; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alessandra Fabi

  Policlinico A. Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 8, 2022
• Study Start: November 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: May 31, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)