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her2 negative breast cancer

Total Trials
12
Recruiting Now
12
Trial Phases
Phase 1, Phase 1, Phase 2, 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.

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 — her2 negative breast cancer Clinical Trials

How many clinical trials are currently recruiting for her2 negative breast cancer?
ClinicalMetric currently tracks 12 actively recruiting clinical trials for her2 negative 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 12. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for her2 negative breast cancer?
her2 negative breast cancer research spans Phase 1 (3 trials), Phase 2 (8 trials), 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 her2 negative breast cancer clinical trial?
Eligibility criteria for her2 negative 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
3
Phase 2
8
Phase 4
1
Top Sponsors
Fudan University 2 trials
Yale University 1 trial
QuantumLeap Healthcare Collaborative 1 trial
University of California, Irvine 1 trial
Oana Danciu 1 trial

Recruiting Clinical Trials

NCT05989347 Phase 1
Recruiting
Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
Enrollment
20 pts
Location
United States
Sponsor
Yale University
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NCT05868226 Phase 1, Phase 2
Recruiting
PRE-ISPY Phase I/II Oncology Platform Program
Enrollment
280 pts
Location
United States
Sponsor
QuantumLeap Healthcare Collabo...
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NCT05582499 Phase 2
Recruiting
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
Enrollment
716 pts
Location
China
Sponsor
Fudan University
View Trial →
NCT06230055 Phase 4
Recruiting
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
Enrollment
37 pts
Location
China
Sponsor
Fudan University
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NCT05524584 Phase 2
Recruiting
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
Enrollment
20 pts
Location
United States
Sponsor
University of California, Irvi...
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NCT05467891 Phase 2
Recruiting
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Enrollment
200 pts
Location
United States
Sponsor
Oana Danciu
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NCT06568692 Phase 2
Recruiting
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
Enrollment
90 pts
Location
United States
Sponsor
Processa Pharmaceuticals
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NCT04230109 Phase 2
Recruiting
Sacituzumab Govitecan In TNBC
Enrollment
239 pts
Location
United States
Sponsor
Massachusetts General Hospital
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NCT06744465
Recruiting
NearWave Optical Molecular Monitoring
Enrollment
15 pts
Location
United States
Sponsor
Indiana University
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NCT06970912 Phase 2
Recruiting
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
Enrollment
393 pts
Location
China
Sponsor
Peking University People's Hos...
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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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NCT05660083 Phase 2
Recruiting
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
Enrollment
36 pts
Location
United States
Sponsor
The Methodist Hospital Researc...
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Related Conditions

breast cancer (6) hormone receptor positive breast cancer (4) her2 positive breast cancer (3) metastatic breast cancer (3) tnbc triple negative breast cancer (3) triple negative breast cancer (2) ctdna monitoring (2) hormone receptor positive tumor (2) early stage breast cancer (2) hyperinsulinism (1) metastatic cancer (1) metastatic (1)
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: September 2026  ·  Data Methodology