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her2 positive breast cancer

Total Trials
18
Recruiting Now
18
Trial Phases
Phase 1, Phase 1, Phase 2, Phase 3

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 positive breast cancer Clinical Trials

How many clinical trials are currently recruiting for her2 positive breast cancer?
ClinicalMetric currently tracks 18 actively recruiting clinical trials for her2 positive 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 18. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for her2 positive breast cancer?
her2 positive breast cancer research spans Phase 1 (2 trials), Phase 2 (6 trials), Phase 3 (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 positive breast cancer clinical trial?
Eligibility criteria for her2 positive 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
2
Phase 2
6
Phase 3
1
Top Sponsors
Shu Wang 3 trials
Fudan University 3 trials
Pravin T.P Kaumaya 1 trial
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 1 trial
QuantumLeap Healthcare Collaborative 1 trial

Recruiting Clinical Trials

NCT06949410 Phase 1
Recruiting
HER2 Vaccine for Locally Advanced Breast Cancer
Enrollment
36 pts
Location
United States
Sponsor
Pravin T.P Kaumaya
View Trial →
NCT07030569
Recruiting
RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study
Enrollment
500 pts
Location
Italy
Sponsor
Fondazione IRCCS Istituto Nazi...
View Trial →
NCT05868226 Phase 1, Phase 2
Recruiting
PRE-ISPY Phase I/II Oncology Platform Program
Enrollment
280 pts
Location
United States
Sponsor
QuantumLeap Healthcare Collabo...
View Trial →
NCT06722612
Recruiting
Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
Enrollment
2,916 pts
Location
China
Sponsor
Shu Wang
View Trial →
NCT06992882 Phase 3
Recruiting
A Randomized, Open-label, Multi-center Phase III Study Comparing the Efficacy of Oral Chemotherapy Combined With Trastuzumab Versus Paclitaxel Combined With Trastuzumab in the Adjuvant Treatment of HER2-positive, Lymph Node-negative Early Breast Cancer Patients(ORCHID-PLUS)
Enrollment
2,306 pts
Location
China
Sponsor
Fudan University
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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 →
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
View Trial →
NCT06358625
Recruiting
Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer
Enrollment
120 pts
Location
France
Sponsor
Center Eugene Marquis
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NCT06693037
Recruiting
Adjuvant Therapy Choice for Non-pCR HER2 Positive Early Breast Cancer After Neoadjuvant Therapy
Enrollment
2,092 pts
Location
China
Sponsor
Shu Wang
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NCT05982678 Phase 2
Recruiting
Basket Study for Oligo-metastatic Breast Cancer
Enrollment
72 pts
Location
Netherlands
Sponsor
The Netherlands Cancer Institu...
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NCT04993014 Phase 2
Recruiting
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Enrollment
80 pts
Location
Brazil
Sponsor
AC Camargo Cancer Center
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NCT04281641
Recruiting
Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
Enrollment
94 pts
Location
China
Sponsor
Fudan University
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NCT06722599
Recruiting
Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among Low Risk HER2 Positive Patients
Enrollment
171 pts
Location
China
Sponsor
Shu Wang
View Trial →
NCT07053085 Phase 2
Recruiting
A Study of Surgery and Radiotherapy in People With Breast Cancer
Enrollment
178 pts
Location
United States
Sponsor
Memorial Sloan Kettering Cance...
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NCT07281001
Recruiting
A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients
Enrollment
60 pts
Location
Russia
Sponsor
Blokhin's Russian Cancer Resea...
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NCT06744465
Recruiting
NearWave Optical Molecular Monitoring
Enrollment
15 pts
Location
United States
Sponsor
Indiana University
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NCT04893109 Phase 2
Recruiting
ATEMPT 2.0: Adjuvant T-DM1 vs TH
Enrollment
500 pts
Location
United States
Sponsor
Dana-Farber Cancer Institute
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NCT06123988
Recruiting
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
Enrollment
260 pts
Location
United States
Sponsor
University of Miami
View Trial →

Related Conditions

breast cancer (5) metastatic breast cancer (3) her2 negative breast cancer (3) breast neoplasms (2) hormone receptor positive breast cancer (2) triple negative breast cancer tnbc (2) radiomic (1) radiomics (1) breast cancer metastatic (1) breast cancer stage iv (1) breast carcinoma (1) breast cancer with bone metastasis (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