Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)

Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study) (NCT04817540) is a Phase 2 interventional studying HER2 Enriched Subtype Breast Cancer, Herzuma, PAM50 Study, sponsored by Gangnam Severance Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against HER2 Enriched Subtype Breast Cancer, Herzuma, PAM50 Study and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 59 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HER2 Enriched Subtype Breast Cancer, Herzuma, PAM50 Study subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Pathologically and cytologically documented unsectable/metastatic breast cancer that : A. has confirmed HER2 negative expression regardless hormone receptor status - definition of HER2 negative breast cancer i) HER2 IHC 1+ without ISH or ii) HER2 IHC 2+ and ISH negative (average HER2 gene copy number \<4 signals/cell in single probe ISH or HER2/CEP17 ratio \<2.0 \& average HER2 gene copy number \<4 signals cell in dual-probe ISH) 2. No prior treatment of stage II-III breast cancer - HR+ \& HER2- breast cancer : cT1-4N1-3 - HR- \& HER2- breast cancer : cT1N1-3 or cT2-4N0-3 3. No systemic metastasis confirmed by pathological or radiological evaluation 4. Patients over 19 years 5. Confirmed to HER2-enriched subtype by PAM50 study 6. Available FFPE 15-20 slides for evaluating PAM50 study 7. ECOG 0-1 8. Adequate bone marrow functions i) blood count (hemoglobin) at least 9g/dL ii) white blood cell count (ANC) at least 1,500/mm3 iii) platelet count at least 100,000/mm3 9. Adequate renal functions i) creatinine : ≤ 1.5 x UNL or ii) creatinine clearance (Ccr) ≥ 50 ml/min by Cockroft formula 10. Adequate liver functions i) Bilirubine : ≤ 1.5 x UNL ii) AST/ALT : ≤ 2.5 x UNL 11. Adequate cardiac functions - LVEF ≥50% (with MUGA scan or TTE) 12. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment. Who Should NOT Join This Trial: - 1\) History of previous treatments of ipsilateral or contralateral invasive breast cancer 2) Confirmation of systemic distant metastasis of breast cancer 3) History of other malignancy within the last 5 years, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, less than 2cm of thyroid cancer (papillary, follicular, medullary). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Pathologically and cytologically documented unsectable/metastatic breast cancer that : A. has confirmed HER2 negative expression regardless hormone receptor status * definition of HER2 negative breast cancer i) HER2 IHC 1+ without ISH or ii) HER2 IHC 2+ and ISH negative (average HER2 gene copy number \<4 signals/cell in single probe ISH or HER2/CEP17 ratio \<2.0 \& average HER2 gene copy number \<4 signals cell in dual-probe ISH) 2. No prior treatment of stage II-III breast cancer * HR+ \& HER2- breast cancer : cT1-4N1-3 * HR- \& HER2- breast cancer : cT1N1-3 or cT2-4N0-3 3. No systemic metastasis confirmed by pathological or radiological evaluation 4. Patients over 19 years 5. Confirmed to HER2-enriched subtype by PAM50 study 6. Available FFPE 15-20 slides for evaluating PAM50 study 7. ECOG 0-1 8. Adequate bone marrow functions i) Hemoglobin≥ 9g/dL ii) ANC ≥1,500/mm3 iii) Platelet ≥100,000/mm3 9. Adequate renal functions i) creatinine : ≤ 1.5 x UNL or ii) creatinine clearance (Ccr) ≥ 50 ml/min by Cockroft formula 10. Adequate liver functions i) Bilirubine : ≤ 1.5 x UNL ii) AST/ALT : ≤ 2.5 x UNL 11. Adequate cardiac functions * LVEF ≥50% (with MUGA scan or TTE) 12. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment. Exclusion Criteria: * 1\) History of previous treatments of ipsilateral or contralateral invasive breast cancer 2) Confirmation of systemic distant metastasis of breast cancer 3) History of other malignancy within the last 5 years, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, less than 2cm of thyroid cancer (papillary, follicular, medullary). 4\) inflammatory breast cancer (cT4d) 5) bilateral breast cancer(except, multifocal or multicentric breast cancer) 6) occult breast cancer 7) History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) 8) Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence \[periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\], sterilization, or other non-hormonal forms of contraception) during treatment 9) Uncontrolled infections and other serious diseases or medical conditions 10) Uncontrolled hyeprtension or clinically active cardiovascular disease: for example, cerebrovascular accident or transient isschemic attack, unstable angina, myocaridal infarction within 6 months prior to enrolment. Have symptomatic congestive heart failure (CHF; New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia. 11\) Have any condition (eg, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggest that the patient is, in the investigator's opinion, not an appropriate candidate for the study 12) Patients who are hypesenstivie reaction to experimental drugs (doxorubicin, cyclophosphamide, paclitaxel, docetaxel, herzuma) 13) Peripheral neuropathy CTCAE v4.03 ≥ grade 2

Treatments Being Tested

DRUG

Herzuma

8mg/kg IVF loading dose at first cycle -\> 6mg/kg IVF at 2,3,4th cycle of each 21 day cycle

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Gangnam Severance Hospital

Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04817540), the sponsor (Gangnam Severance Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04817540 clinical trial studying?

In this study, we prospectively analyzed molecular subtyping through the PAM 50 test in HER2-negative (IHC1+ or 2+ (FISH/SISH-)) breast cancer patients. A phase 2 single arm study was designed to determine whether the addition of HER2-targeted treatment with treatment increases the pathologic remission rate. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04817540?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04817540?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04817540. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04817540. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.