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metastatic breast cancer

Total Trials
25
Recruiting Now
25
Trial Phases
Phase 3, Phase 2, Phase 1, Phase 2

Cancer clinical trials represent the largest single category of recruiting studies worldwide, encompassing everything from early-phase safety studies of novel oncology drugs to large Phase 3 comparisons against current standard-of-care chemotherapy regimens. The field has accelerated dramatically with the rise of immunotherapy, targeted therapies, and CAR-T cell treatments that have transformed outcomes for previously untreatable malignancies.

Trials include checkpoint inhibitors (PD-1/PD-L1 agents), KRAS inhibitors, ADC (antibody-drug conjugates), combination chemotherapy regimens, radiation protocols, and surgical technique comparisons. Many trials stratify by biomarker status (PD-L1 expression, TMB, MSI-H) to identify patients most likely to benefit.

The NCI, pharmaceutical sponsors, and academic cancer centers collectively fund thousands of oncology trials annually across every cancer type.

Frequently Asked Questions — metastatic breast cancer Clinical Trials

How many clinical trials are currently recruiting for metastatic breast cancer?
ClinicalMetric currently tracks 25 actively recruiting clinical trials for metastatic breast cancer, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 25. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for metastatic breast cancer?
metastatic breast cancer research spans Phase 1 (8 trials), Phase 2 (10 trials), Phase 3 (3 trials). Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a metastatic breast cancer clinical trial?
Eligibility criteria for metastatic breast cancer trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Trial Phases
Phase 1
8
Phase 2
10
Phase 3
3
Top Sponsors
Hoffmann-La Roche 2 trials
UNICANCER 1 trial
The Netherlands Cancer Institute 1 trial
Korea University Guro Hospital 1 trial
Hunan Cancer Hospital 1 trial

Recruiting Clinical Trials

NCT05552001 Phase 3
Recruiting

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

Enrollment
96 pts
Location
France
Sponsor
UNICANCER
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NCT06342037 Phase 2
Recruiting

NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial

Enrollment
60 pts
Location
Netherlands
Sponsor
The Netherlands Cancer Institu...
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NCT03424005 Phase 1, Phase 2
Recruiting

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Enrollment
792 pts
Location
United States, Austr...
Sponsor
Hoffmann-La Roche
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NCT05816655 Phase 2
Recruiting

Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Enrollment
202 pts
Location
South Korea
Sponsor
Korea University Guro Hospital
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NCT07073755
Recruiting

Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd

Enrollment
200 pts
Location
China
Sponsor
Hunan Cancer Hospital
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NCT03449238 Phase 1, Phase 2
Recruiting

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Enrollment
41 pts
Location
United States
Sponsor
Weill Medical College of Corne...
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NCT07049133
Recruiting

Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer

Enrollment
84 pts
Location
Italy
Sponsor
European Institute of Oncology
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NCT05573126 Phase 1, Phase 2
Recruiting

Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

Enrollment
95 pts
Location
United States, Spain...
Sponsor
Ellipses Pharma
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NCT03577197
Recruiting

Southeast Netherlands Advanced Metastatic Breast Cancer Registry

Enrollment
7,000 pts
Location
Netherlands
Sponsor
Academisch Ziekenhuis Maastric...
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NCT06991946
Recruiting

Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Cancer in Spain

Enrollment
300 pts
Location
Spain
Sponsor
SOLTI Breast Cancer Research G...
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NCT06962163
Recruiting

Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients

Enrollment
12 pts
Location
France
Sponsor
Institut Cancerologie de l'Oue...
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NCT04965766 Phase 2
Recruiting

Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

Enrollment
139 pts
Location
France
Sponsor
Gustave Roussy, Cancer Campus,...
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NCT05894239 Phase 3
Recruiting

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

Enrollment
230 pts
Location
United States, Argen...
Sponsor
Hoffmann-La Roche
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NCT06135714 Phase 3
Recruiting

Metastasis-directed Therapy for Oligometastases of Breast Cancer

Enrollment
340 pts
Location
Japan
Sponsor
Tokyo Medical and Dental Unive...
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NCT06055881
Recruiting

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy

Enrollment
45 pts
Location
United States
Sponsor
Mayo Clinic
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NCT06774027
Recruiting

Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer

Enrollment
100 pts
Location
United States
Sponsor
University of California, San ...
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NCT04115306 Phase 1, Phase 2
Recruiting

Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer

Enrollment
61 pts
Location
United States
Sponsor
Phoenix Molecular Designs
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NCT06110793 Phase 1, Phase 2
Recruiting

A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer

Enrollment
54 pts
Location
United States
Sponsor
Memorial Sloan Kettering Cance...
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NCT06405828
Recruiting

Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer

Enrollment
67 pts
Location
United States
Sponsor
Icahn School of Medicine at Mo...
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NCT06064812 Phase 1, Phase 2
Recruiting

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Enrollment
99 pts
Location
China
Sponsor
Forward Pharmaceuticals Co., L...
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NCT05544240 Phase 1
Recruiting

Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced/Metastatic Solid Tumors

Enrollment
20 pts
Location
Mexico
Sponsor
Williams Cancer Foundation
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NCT07066917
Recruiting

Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer

Enrollment
150 pts
Location
Greece
Sponsor
Hellenic Cooperative Oncology ...
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NCT07222215 Phase 2
Recruiting

PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

Enrollment
297 pts
Location
United States
Sponsor
Kristina A. Fanucci
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NCT06784193 Phase 1
Recruiting

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

Enrollment
180 pts
Location
United States, Austr...
Sponsor
Olema Pharmaceuticals, Inc.
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NCT07068477
Recruiting

Adaptation of a Values Assessment Tool

Enrollment
40 pts
Location
United States
Sponsor
UNC Lineberger Comprehensive C...
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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology