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Active HER2-Positive Breast Cancer Clinical Trials

HER2-positive breast cancer overexpresses the HER2 protein, making it responsive to targeted therapies. Trials are advancing trastuzumab deruxtecan (T-DXd), tucatinib combinations, and novel HER2-targeted approaches — including emerging options for HER2-low disease.

Find HER2-Positive Breast Cancer Trials

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Why Consider a HER2-Positive Breast Cancer Clinical Trial?

  • Find Trials That Fit — Browse recruiting HER2-Positive Breast Cancer trials pulled directly from ClinicalTrials.gov — updated continuously so you always see real, active studies.
  • No Medical Jargon — Eligibility criteria are rewritten into plain yes-or-no questions. It's always okay to answer "not sure" — your doctor can help fill in the rest.
  • See How Well You Match — Get a clear picture of how closely a trial fits your situation, so you know which ones are worth bringing to your oncologist.
  • Ready for Your Appointment — Generate a printable or emailable summary for your next visit. A caregiver can send it to your doctor ahead of time.

How It Works

  1. Share a Few Details — Enter your HER2-Positive Breast Cancer type, stage, and location. No personal health information is required or stored.
  2. Answer Yes-or-No Questions — We rewrite complex eligibility criteria into plain language. "Not sure" is always a valid answer.
  3. Bring Results to Your Doctor — Get a printable summary with the NCT ID, match assessment, and questions to ask your oncologist.
Search HER2-Positive Breast Cancer Trials

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HER2-Positive Breast Cancer Clinical Trial FAQ

What is the difference between HER2-positive and HER2-low breast cancer for trial eligibility?
HER2-positive breast cancer (IHC 3+ or FISH amplified) is eligible for anti-HER2 targeted therapies. HER2-low (IHC 1+ or IHC 2+/FISH non-amplified) was historically considered HER2-negative but is now treated as a distinct category since trastuzumab deruxtecan (T-DXd / Enhertu) showed benefit in this group. Many ongoing trials enroll both HER2-positive and HER2-low patients, dramatically expanding the population that can access HER2-targeted trial drugs.
Are there HER2-positive breast cancer trials for patients with brain metastases?
Yes — brain metastases occur in 30–50% of metastatic HER2-positive breast cancer patients. Tucatinib (Tukysa) plus trastuzumab and capecitabine has shown activity in brain metastases and is now FDA-approved for this indication. Clinical trials are testing tucatinib combinations, T-DXd for leptomeningeal disease, and novel agents specifically designed to penetrate the blood-brain barrier.
What HER2-targeted drugs are currently being studied in clinical trials?
Active trials are testing: trastuzumab deruxtecan (T-DXd) combinations and earlier-line use, tucatinib-based regimens, novel bispecific antibodies targeting HER2 and other antigens (HER2 + HER3), CAR-T therapies targeting HER2, and small-molecule HER2 inhibitors targeting HER2 activating mutations (distinct from HER2 amplification). The HER2 landscape is rapidly evolving.
Can early-stage HER2-positive patients join clinical trials?
Yes. Neoadjuvant and adjuvant trials are active for early-stage HER2-positive breast cancer. These test whether adding new agents to the standard trastuzumab + pertuzumab backbone improves outcomes, or whether novel combinations can replace more toxic regimens. Patients who do not achieve a complete pathologic response (pCR) after neoadjuvant therapy are a particularly active trial population.
How many lines of prior HER2-targeted therapy can I have before joining a trial?
It depends on the specific trial. Some trials test HER2-targeted agents in the first-line setting (no prior HER2-directed therapy in the metastatic setting). Others specifically enroll patients who have received two or more prior HER2-targeted regimens. Trialify will ask about your prior HER2-targeted therapy history so you only see trials that match your treatment background.

Explore Other Cancer Trial Guides

  • Breast Cancer — Breast cancer trials are testing innovative therapies for all subtypes — HER2+, triple-negative (TNBC), and hormone receptor-positive. New options are opening every month at cancer centers across the country.
  • Triple-Negative Breast Cancer (TNBC) — Triple-negative breast cancer (TNBC) lacks estrogen receptor, progesterone receptor, and HER2 expression, making it harder to treat with hormone or HER2-targeted therapy. Immunotherapy (pembrolizumab), antibody-drug conjugates (sacituzumab govitecan), and PARP inhibitors for BRCA-mutated TNBC are among the most active trial areas.
  • Ovarian Cancer — Ovarian cancer trials are investigating PARP inhibitor combinations, antibody-drug conjugates, folate receptor-targeted therapy, and immunotherapy — with studies available for both platinum-sensitive and resistant disease.
  • Lung Cancer — Lung cancer is the leading cause of cancer-related death worldwide. Recruiting clinical trials are testing new immunotherapies, targeted therapies, and combination regimens for NSCLC and SCLC patients.