Updated daily · U.S. National Library of Medicine

Breast Cancer Clinical Trials

We surface recruiting trials from ClinicalTrials.gov with plain-English eligibility guidance. Whether you are HER2+, triple-negative, or post-CDK4/6 inhibitor, knowing your molecular profile determines which trials you qualify for.

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Data sourced from the U.S. National Library of Medicine. Plain-English summaries are AI-generated to help you understand — always verify with your medical team.

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Key biomarkers for breast cancer trials

Breast cancer trial eligibility is driven by your tumor's molecular profile. These biomarkers appear most often in eligibility criteria — find them on your pathology report and genomic testing results.

HER2+ (IHC 3+ / FISH+)
~20% of breast cancers
Targeted by trastuzumab, pertuzumab, T-DM1, and trastuzumab deruxtecan. The most trial-rich breast cancer subtype — dozens of Phase 2/3 studies recruiting.
Find HER2+ trials →
HER2-low (IHC 1+ or 2+/FISH-)
~55% of HER2-negative tumors
A recently defined subtype with expanding trial options. Trastuzumab deruxtecan (Enhertu) is approved; multiple trials testing it in earlier lines and new combinations.
Find HER2-low trials →
Triple-negative (TNBC)
~15% of breast cancers
ER-/PR-/HER2-. No hormonal or HER2 target — trials focus on immunotherapy (pembrolizumab), PARP inhibitors (BRCA-mutant), sacituzumab govitecan, and TROP2 agents.
Find TNBC trials →
ER+/PR+ (Hormone receptor+)
~70% of breast cancers
Most common subtype. Trials after CDK4/6 inhibitor progression (palbociclib, ribociclib, abemaciclib) are widely available — ESR1 and PIK3CA mutations guide next steps.
Find ER+ trials →
BRCA1 / BRCA2
~5–10% of breast cancers
Germline BRCA mutations qualify for PARP inhibitor trials — olaparib, talazoparib, niraparib combinations. Both BRCA-mutant TNBC and ER+ patients have options.
Find BRCA trials →
PIK3CA mutation
~40% of ER+ breast cancers
Targeted by alpelisib (Piqray) in combination with fulvestrant. Multiple PI3K pathway trials recruiting for ER+ patients who progressed on CDK4/6 inhibitors.
Find PIK3CA trials →
Not sure which biomarkers you have? Upload your pathology or genomic report. We'll read it and match you to recruiting trials →

Common questions about breast cancer trials

The key biomarkers for breast cancer trial eligibility are: HER2 status (IHC 3+ or FISH+ = HER2-positive; IHC 1+ or 2+/FISH- = HER2-low), hormone receptor status (ER+/PR+), triple-negative status (ER-/PR-/HER2-), BRCA1/BRCA2 germline mutation, PIK3CA mutation, and PD-L1 expression (CPS score).

Ask your oncologist for comprehensive genomic testing — these results directly determine which trials you qualify for.

Yes. HER2-low (IHC 1+ or IHC 2+/FISH-) is a rapidly expanding area. Trastuzumab deruxtecan (Enhertu) is already approved for HER2-low metastatic breast cancer, and multiple Phase 2/3 trials are recruiting for earlier lines, new combinations, and patients who progressed on T-DXd.

Confirm your HER2 IHC score from your pathology report — even 1+ qualifies as HER2-low.

Upload your pathology report to see your HER2-low trial options →

Post-CDK4/6 inhibitor progression is one of the most active areas for breast cancer trials. Options by profile: PIK3CA-mutant → PI3K inhibitor trials (alpelisib combinations); BRCA-mutant → PARP inhibitor trials; ESR1-mutant (get a liquid biopsy) → novel endocrine therapy trials (elacestrant, imlunestrant); HER2-low → ADC trials (T-DXd, datopotamab).

BRCA-mutant patients have strong trial options. Approved agents include olaparib (Lynparza) and talazoparib (Talzenna). Active trials include: PARP inhibitor + immunotherapy combinations, newer PARP inhibitors in earlier lines, and neoadjuvant trials for early-stage BRCA-mutant patients.

Both germline and somatic BRCA mutations may qualify — confirm with your oncologist whether you've had germline genetic testing.

Yes. Trials exist at every stage. After surgery: adjuvant trials test treatments to prevent recurrence. For metastatic patients who had prior surgery, most trials focus on systemic therapy regardless of surgical history.

Upload your surgical and pathology reports — Alongside matches you to trials appropriate for your current disease status and treatment history.

Each trial on ClinicalTrials.gov lists a central contact number and email. Lead with: your diagnosis ("metastatic ER+/HER2- breast cancer"), your biomarker status ("PIK3CA-mutant, post-CDK4/6 inhibitor"), and treatment history.

Alongside provides a word-for-word phone script and email template customized to your profile.

Understanding clinical trials

What is a Phase 1, 2, or 3 trial?

Phase 1 tests safety. Phase 2 tests whether the treatment works. Phase 3 compares the new treatment against the current standard. Most patients look for Phase 2 or 3 trials, where the treatment has shown early promise.

What is an inclusion/exclusion criteria?

Every trial has a checklist of who can and cannot join. These might include your cancer stage, specific gene mutations, prior treatments, age, and overall health. Meeting these is required — not optional.

Do I have to pay for a clinical trial?

No. The experimental treatment in a clinical trial is free. You may still have to pay for routine care like doctor visits, but the trial drug or procedure itself is covered by the sponsor.

What does "recruiting" mean?

Recruiting means the trial is actively looking for participants right now. "Not yet recruiting" means it's approved but hasn't started. "Active, not recruiting" means it's ongoing but has all the participants it needs.