Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Herzuma
Drug8mg/kg IVF loading dose at first cycle -\> 6mg/kg IVF at 2,3,4th cycle of each 21 day cycle
Treatment groups
59 Participants
are divided into 1 treatment groupGroup A: Single arm, Herzuma armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
pathologic complete response rate (%, ypT0/isN0)
TPathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla(ypT0/isYpN0), in participants who received at least 1 cycle of herzuma and taxane in HER2-enriched subtype breast cancer
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov