Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients
NCT06690840 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-01-05
Summary
Triple-negative breast cancer (TNBC) is among the most aggressive and lethal types of breast cancer, and currently available therapies have an unsatisfactory impact on patients' survival.
The primary aim of this clinical trial is to evaluate efficacy in terms of Overall Response Rate (ORR) of atezolizumab plus cyclophosphamide and vinorelbine in first line patients with unresectable locally advanced or metastatic TNBC patients, previously treated with anti-programmed cell death ligand-1 (PD-L1) or anti-programmed cell death-1 (PD-1) - containing regimens, in the neoadjuvant/adjuvant setting.
Conditions
Interventions
- DRUG
-
Atezolizumab in combination with Cyclophosphamide and Vinorelbine
Patients will receive Atezolizumab in combination with Cyclophosphamide and Vinorelbine in 28-day cycles
Sponsors & Collaborators
-
European Institute of Oncology
lead OTHER
Principal Investigators
-
Elisabetta Munzone, MD · European Istitute of Oncology
-
Francesco Bertolini · European Istitute of Oncology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-06
- Primary Completion
- 2026-12-15
- Completion
- 2027-02-15
Countries
- Italy
Study Locations
More Related Trials
-
A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
NCT04584112 ·Status: COMPLETED ·Phase: PHASE1
-
the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After First Line Treatment
NCT03358004 ·Status: TERMINATED ·Phase: PHASE2
-
Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
NCT00003730 ·Status: COMPLETED ·Phase: NA
-
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
NCT02555657 ·Status: COMPLETED ·Phase: PHASE3
-
Triple-B Study;Carboplatin-cyclophosphamide Versus Paclitaxel With or Without Atezolizumab as First-line Treatment in Advanced Triple Negative Breast Cancer
NCT01898117 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
NCT03106077 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)
NCT04191135 ·Status: COMPLETED ·Phase: PHASE2
-
Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer
NCT00431106 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer
NCT04690855 ·Status: TERMINATED ·Phase: PHASE2
-
Atezolizumab Combined with Immunogenic Chemotherapy in Patients with Metastatic Triple-negative Breast Cancer
NCT03164993 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT03106415 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer
NCT03199885 ·Status: COMPLETED ·Phase: PHASE3
-
Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer
NCT04759248 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
NCT03811418 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer
NCT01565083 ·Status: COMPLETED ·Phase: PHASE2
-
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)
NCT03109080 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
NCT03742102 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Salvage Chemotherapy of Vinorelbine Plus Oxaliplatin in Metastatic Triple-negative Breast Cancer:a Prospective Trial
NCT01528826 ·Status: UNKNOWN ·Phase: PHASE2
-
All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer:a Multi-center, Multi-cohort Phase II Trial
NCT06636981 ·Status: RECRUITING ·Phase: PHASE2
-
Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients
NCT00128310 ·Status: COMPLETED ·Phase: PHASE3
-
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
NCT03330847 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
NCT03606967 ·Status: RECRUITING ·Phase: PHASE2
-
Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer
NCT02768701 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
NCT03256344 ·Status: COMPLETED ·Phase: PHASE1
-
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer
NCT02826434 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1