Metastatic breast cancer trials in Italy

In Italy 70 Also abroad 610

70 trials · From ClinicalTrials.gov and EU CTIS (euclinicaltrials.eu), checked 11 November 2026. Ask the study team whether a trial fits you.

Phase 1/2Taking people
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
Where
Bologna, Genoa, Milan, Naples, Rome
Age
18 years and over
People
380 worldwide
Run by
BioNTech SE
See details and how to joinNCT06827236 · EU 2024-517979-20-00
Phase 2Taking people
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Where
Bergamo, Bologna, Genova, Milan, Monza, Novara, Torrette
Age
18 years and over
People
120 worldwide
Run by
ALX Oncology Inc.
See details and how to joinNCT07007559
Phase 3Taking people
BGB-43395 in Combination with Letrozole versus CDK4/6i with Letrozole for Patients with Previously Untreated Advanced or Metastatic HR+/HER2- Breast Cancer
Where
Ancona, Bergamo, Genoa, Milan, Monza, Padova, Rome
Age
18 years and over
People
233 worldwide
Run by
BeOne Medicines I GmbH
See details and how to joinNCT07492641 · EU 2025-523960-19-00
Phase 1/2Taking people
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Where
Ancona, Candiolo (TO), Meldola (FC), Milan, Misterbianco (CT), Naples, Rozzano
Age
18 years and over
People
910 worldwide
Run by
Boehringer Ingelheim
See details and how to joinNCT06324357
Phase 3Taking people
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
Where
Ancona, Brescia, Candiolo, Caserta, Empoli, Ferrara, Florence, Leghorn, Meldola, Milan, Misterbianco, Padova, Palermo, Parma, Pavia, Rome, Terni
Age
18 years and over
People
540 worldwide
Run by
Relay Therapeutics, Inc.
See details and how to joinNCT06982521 · EU 2025-523083-21-00
Phase 2/3Taking people
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
Where
Aviano, Bergamo, Brescia, Meldola, Milan, Misterbianco (CT), Modena, Naples, Padova, Parma, Rome, Rozzano
Age
18 years and over
People
650 worldwide
Run by
Hoffmann-La Roche
See details and how to joinNCT07413939 · EU 2025-524498-17-00
Phase 3Taking people
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Where
Bergamo, Bologna, Bolzano, Caserta, Meldola, Milan, Misterbianco, Modena, Naples, Novara, Pisa, Rome, Rozzano, Terni, Tricase
Age
18 years and over
People
450 worldwide
Run by
Hoffmann-La Roche
See details and how to joinNCT06790693 · EU 2024-516162-11-00
Phase 3Taking people
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
Where
Bergamo, Bologna, Florence, Genova, Meldola, Milan, Misterbianco, Monza, Naples, Padova, Roma
Age
18 years and over
People
800 worldwide
Run by
Eli Lilly and Company
See details and how to joinNCT07174336 · EU 2025-522791-92-00
Phase 3Taking people
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Where
Bergamo, Milan, Naples, Roma
Age
18 years and over
People
1,000 worldwide
Run by
Merck Sharp & Dohme LLC
See details and how to joinNCT07060807 · EU 2025-520582-51-00
Phase 2Taking people
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Where
Bergamo, Meldola, Milan, Naples, Rome
Age
18 years and over
People
80 worldwide
Run by
Hoffmann-La Roche
See details and how to joinNCT07405801 · EU 2025-523013-28-00
Phase 1Taking people
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
Where
Ancona
Age
18 years and over
People
194 worldwide
Run by
Novartis Pharmaceuticals
See details and how to joinNCT07604571
Phase 3Taking people
A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment (EmpowHER 303)
Where
Ancona, Aviano, Bergamo, Bologna, Busto Arsizio, Catania, Genoa, Milan, Modena, Monza, Naples, Padova, Pavia, Rivoli, Rome, Rozzano
Age
18 years and over
People
264 worldwide
Run by
Jazz Pharmaceuticals Ireland Limited
See details and how to joinNCT06435429 · EU 2023-508960-31-00
Phase 3Taking people
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
Where
Bergamo, Bologna, Milan, Naples, Padova, Reggio Emilia, Rome, Rozzano
Age
18 years and over
People
788 worldwide
Run by
AstraZeneca
See details and how to joinNCT06380751 · EU 2023-504180-16-00
Phase 3Taking people
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Where
Ancona, Aviano, Candiolo, Meldola, Milan, Misterbianco, Modena, Naples, Padova, Parma, Pavia, Rome
Age
18 years and over
People
600 worldwide
Run by
LeonaBio
See details and how to joinNCT05696626 · EU 2023-503708-10-00
Phase 3Taking people
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
Where
Caserta, Meldola, Milan, Trento
Age
18 years and over
People
420 worldwide
Run by
Hoffmann-La Roche
See details and how to joinNCT05646862 · EU 2022-502322-41-00
Phase 1/2Taking people
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Where
Candiolo, Milan, Naples, Rome, Rozzano
Age
18 years and over
People
680 worldwide
Run by
Daiichi Sankyo
See details and how to joinNCT06330064 · EU 2023-509632-26-00
Phase 1Not yet taking people in Italy
A phase I study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in patients with solid tumors
Where
Milan, Naples
Age
18 years and over
People
64 worldwide
Run by
Novartis Pharma AG
See details and how to join2024-518348-19-00 · EU 2024-518348-19-00
Phase 1Taking people
A clinical trial to learn about the effects of IEV407 when given alone or with endocrine therapy in people with advanced breast cancer
Where
Ancona
Age
18 years and over
People
40 worldwide
Run by
Novartis Pharma AG
See details and how to join2025-522707-26-00 · EU 2025-522707-26-00
Phase 2Taking people
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease
Where
Milan
Age
18 years and over
People
90 worldwide
Run by
Delcath Systems Inc.
See details and how to joinNCT06875128 · EU 2025-521966-91-00
Phase 3Taking people
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
Where
Bologna, Leghorn, Meldola, Milan, Modena, Monza, Naples, Rome
Age
18 years and over
People
400 worldwide
Run by
Pfizer
See details and how to joinNCT07062965 · EU 2025-520566-22-00
Phase 3Taking people
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
Where
Aviano, Bergamo, Genova, Milan, Naples
Age
18 years to 130 years
People
150 worldwide
Run by
AstraZeneca
See details and how to joinNCT07647328
Phase 3Taking people
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Where
Bagno A Ripoli, Meldola, Milan, Monza, Novara, Palermo, Rome, Verona
Age
18 years and over
People
230 worldwide
Run by
Hoffmann-La Roche
See details and how to joinNCT05894239 · EU 2022-502046-28-00
Phase 3Taking people
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
Where
Aviano, Bologna, Genova, Meldola, Milan, Roma, Rozzano
Age
18 years and over
People
1,200 worldwide
Run by
Merck Sharp & Dohme LLC
See details and how to joinNCT06312176 · EU 2023-504918-29-00
Phase 1/2Taking people
To compare the Safety and activity of GDC-4198 Alone and in Combination with Giredestrant against Abemaciclib and Giredestrant in Participants with Breast Cancer
Where
Bergamo, Bologna, Brescia, Meldola, Milan
Age
18 years and over
People
73 worldwide
Run by
Genentech Inc.
See details and how to join2025-521128-31-00 · EU 2025-521128-31-00
Phase 3Taking people
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Where
Fano, Genoa, Meldola, Milan, Modena, Naples, Parma, Pavia, Prato, Ravenna, Rome, Rozzano, Terni, Verona
Age
18 years and over
People
1,180 worldwide
Run by
Celcuity Inc
See details and how to joinNCT06757634 · EU 2024-518933-28-01