Actively Recruiting
Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)
Led by Gangnam Severance Hospital · Updated on 2023-10-11
59
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically and cytologically confirmed unsectable or metastatic breast cancer with HER2 negative expression regardless of hormone receptor status
- No prior treatment for stage II-III breast cancer
- No systemic metastasis confirmed by pathological or radiological evaluation
- Patients aged 19 years or older
- Confirmed HER2-enriched subtype by PAM50 test
- Availability of 15-20 FFPE slides for PAM50 analysis
- ECOG performance status of 0 or 1
- Adequate bone marrow function: Hemoglobin ≥ 9 g/dL, ANC ≥ 1,500/mm3, Platelets ≥ 100,000/mm3
- Adequate renal function: creatinine ≤ 1.5 x UNL or creatinine clearance ≥ 50 ml/min
- Adequate liver function: Bilirubin ≤ 1.5 x UNL, AST/ALT ≤ 2.5 x UNL
- Adequate cardiac function with LVEF ≥ 50% by MUGA scan or TTE
- Females of childbearing potential must have a negative pregnancy test within 72 hours before first treatment dose
You will not qualify if you...
- History of previous treatments for ipsilateral or contralateral invasive breast cancer
- Confirmed distant metastasis of breast cancer
- History of other malignancies within the last 5 years except specific treated skin or cervical cancers and small thyroid cancers
- Inflammatory breast cancer (cT4d)
- Bilateral breast cancer except multifocal or multicentric
- Occult breast cancer
- Positive for hepatitis B surface antigen, hepatitis C virus, or HIV
- Women of childbearing potential not agreeing to use highly effective contraception during treatment
- Uncontrolled infections or serious medical conditions
- Uncontrolled hypertension or active cardiovascular disease including recent stroke, unstable angina, or recent myocardial infarction
- Symptomatic congestive heart failure or poorly controlled cardiac arrhythmia
- Any condition that impedes compliance with study procedures
- Hypersensitivity to study drugs including doxorubicin, cyclophosphamide, paclitaxel, docetaxel, or Herzuma
- Peripheral neuropathy grade 2 or higher by CTCAE v4.03
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gangnam Severance Hospital
Seoul, South Korea, 135720
Actively Recruiting
Research Team
J
Jun Jeong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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