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Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy

NCT04770272 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2026-01-12

Study results available
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Summary

This is a randomized, open-label, adaptive, two arm, multicentre, Phase II trial comparing a neoadjuvant chemotherapy with PDL1-inhibition (Atezolizumab) and Atezolizumab two-week window to chemotherapy with PDL1-inhibition (Atezolizumab) and identify biomarkers predicting (early) response to or resistance against Atezolizumab (alone and with CTX) allowing patients stratification in future clinical trials

Conditions

  • Triple-negative Breast Cancer

Interventions

DRUG

Atezolizumab 840 MG in 14 ML Injection

840 mg Day 1 for two weeks

DRUG

Atezolizumab 1200 MG in 20 ML Injection

1200 mg Day 1 every 3 weeks for 8 cycles

DRUG

Carboplatin

Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles

DRUG

Paclitaxel

Paclitaxel 80 mg/m² IV weekly x 12 cycles

DRUG

Epirubicin

90 mg/m2, day 1 for 4 cycles (12 weeks)

DRUG

Cyclophosphamide

600 mg/m2, day 1 for 4 cycles (12 weeks)

PROCEDURE

Biopsy Arm A

1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.

PROCEDURE

Biopsy Arm B

1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.

PROCEDURE

Surgery

After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Phaon Scientific GmbH

    collaborator UNKNOWN

  • University Hospital, Essen

    collaborator OTHER

  • University Hospital Erlangen

    collaborator OTHER

  • Palleos Healthcare GmbH

    lead INDUSTRY

Principal Investigators

  • Iris Reiser, Dr. · Palleos Healthcare GmbH

  • Hans-Christian Kolberg, Prof. Dr. · Marienhospital Bottrop gGmbH; Klinik für Frauenheilkunde und Geburtshilfe; 46236 Bottrop

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-07-06
Completion
2024-10-02

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770272 on ClinicalTrials.gov