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advanced breast cancer

Total Trials
11
Recruiting Now
11
Trial Phases
Phase 1, Phase 2, Phase 4

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.

Disease Burden & Epidemiology

Cancer is a leading cause of death globally, with approximately 19.3 million new cases and 10 million deaths recorded in 2020 according to the Global Cancer Observatory. In the United States alone, the American Cancer Society estimates roughly 1.9 million new cancer diagnoses annually. The lifetime risk of developing invasive cancer is approximately 40% for men and 39% for women in the US. While survival rates have improved substantially β€” the five-year survival rate across all cancers has risen from 49% in the 1970s to approximately 68% today β€” the disease remains the second leading cause of death in high-income countries. Lung, colorectal, breast, and prostate cancers collectively account for the highest incidence and mortality globally, while rare malignancies such as pancreatic and glioblastoma continue to carry the poorest prognoses. Geographic variation is substantial: low- and middle-income countries bear a disproportionate burden due to limited screening infrastructure, delayed diagnosis, and restricted access to systemic therapy. Clinical trials are essential to improving these outcomes at a population level.

Key Research Trends & Landmark Studies

The past decade has produced transformative trial results that have fundamentally changed cancer treatment standards. The KEYNOTE-024 trial established pembrolizumab as first-line standard of care for high PD-L1 non-small cell lung cancer, replacing chemotherapy in a defined biomarker population. The CheckMate 067 trial demonstrated durable 10-year survival in advanced melanoma patients receiving nivolumab plus ipilimumab combination immunotherapy. The DESTINY-Breast03 trial validated trastuzumab deruxtecan (T-DXd) as superior to standard HER2-targeted therapy in HER2-positive breast cancer, accelerating the ADC class across tumor types. In hematology, the TRANSCEND trial led to axicabtagene ciloleucel approval for relapsed DLBCL, establishing CAR-T cell therapy as standard salvage in B-cell lymphoma. The SOLO-1 trial confirmed olaparib (PARP inhibitor) benefit in BRCA-mutated ovarian cancer maintenance, validating germline testing as a standard oncology workflow. Currently active platform trials β€” including NCI-MATCH, TAPUR, and ASCO TARGET β€” use basket and umbrella designs to match patients to experimental therapies based on molecular tumor profiling rather than histological site of origin.

Patient Guide: How to Find & Join a Trial

If you or a family member has been diagnosed with cancer, discussing clinical trial eligibility with your oncologist at every treatment decision point is strongly recommended β€” not just at relapse. Academic cancer centers affiliated with the NCI Cancer Center Program (51 designated centers) typically offer the widest trial portfolio and dedicated clinical trials navigation services. To search independently, filter by your cancer type, treatment history, and location on this page or directly on ClinicalTrials.gov. When reviewing a trial, focus on the eligibility criteria section: prior treatment requirements, performance status (ECOG 0-2 is most common), biomarker requirements, and organ function thresholds are the most frequent barriers to enrollment. Ask your care team about tissue and blood banking β€” many trials require archival biopsy material for biomarker testing before enrollment. Most Phase 2 and 3 oncology trials cover experimental treatment costs; standard-of-care costs may or may not be covered by insurance.

Frequently Asked Questions — advanced breast cancer Clinical Trials

How many clinical trials are currently recruiting for advanced breast cancer?
ClinicalMetric currently tracks 11 actively recruiting clinical trials for advanced 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 11. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for advanced breast cancer?
advanced breast cancer research spans Phase 1 (4 trials), Phase 2 (2 trials), Phase 3 (1 trial), Phase 4 (1 trial). 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 advanced breast cancer clinical trial?
Eligibility criteria for advanced 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
4
Phase 2
2
Phase 3
1
Phase 4
1
Top Sponsors
Wenjin Yin 2 trials
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS 1 trial
Jiangsu Hansoh Pharmaceutical Co., Ltd. 1 trial
Fudan University 1 trial
Peking University People's Hospital 1 trial

Recruiting Clinical Trials

NCT06895291
Recruiting
Whole Body MRI in Oncology
Enrollment
1,000 pts
Location
Italy
Sponsor
Istituto Romagnolo per lo Stud...
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NCT06769425 Phase 1
Recruiting
HS-10502 Combination Treatment in Patients With Advanced Solid Tumors
Enrollment
157 pts
Location
China
Sponsor
Jiangsu Hansoh Pharmaceutical ...
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NCT05949541 Phase 2
Recruiting
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
Enrollment
265 pts
Location
China
Sponsor
Fudan University
View Trial →
NCT07600164 Phase 4
Recruiting
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
Enrollment
500 pts
Location
China
Sponsor
Peking University People's Hos...
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NCT06555588
Recruiting
Engage Psychosocial Intervention for Cancer Symptoms
Enrollment
190 pts
Location
United States
Sponsor
Duke University
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NCT07180160 Phase 2
Recruiting
Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
Enrollment
123 pts
Location
China
Sponsor
Wenjin Yin
View Trial →
NCT07524322 Phase 1
Recruiting
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Enrollment
63 pts
Location
United States
Sponsor
Regor Pharmaceuticals Inc.
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NCT07683754 Phase 3
Recruiting
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd
Enrollment
200 pts
Location
United States
Sponsor
Daiichi Sankyo
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NCT06638307 Phase 1
Recruiting
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
Enrollment
240 pts
Location
United States, Spain
Sponsor
Stemline Therapeutics, Inc.
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NCT05876065
Recruiting
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
Enrollment
86 pts
Location
China
Sponsor
Wenjin Yin
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NCT06120283 Phase 1
Recruiting
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Enrollment
433 pts
Location
United States, Austr...
Sponsor
BeOne Medicines
View Trial →

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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: November 2026  ·  Data Methodology