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

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04817540
Collaborator
(none)
59
Enrollment
1
Arm
70.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
59 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Mar 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm, Herzuma arm

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

Outcome Measures

Primary Outcome Measures

  1. pathologic complete response rate (%, ypT0/isN0) [12 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Pathologically and cytologically documented unsectable/metastatic breast cancer that :
  1. 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)
  1. 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

  1. No systemic metastasis confirmed by pathological or radiological evaluation

  2. Patients over 19 years

  3. Confirmed to HER2-enriched subtype by PAM50 study

  4. Available FFPE 15-20 slides for evaluating PAM50 study

  5. ECOG 0-1

  6. Adequate bone marrow functions i) Hemoglobin≥ 9g/dL ii) ANC ≥1,500/mm3 iii) Platelet ≥100,000/mm3

  7. Adequate renal functions i) creatinine : ≤ 1.5 x UNL or ii) creatinine clearance (Ccr) ≥ 50 ml/min by Cockroft formula

  8. Adequate liver functions i) Bilirubine : ≤ 1.5 x UNL ii) AST/ALT : ≤ 2.5 x UNL

  9. Adequate cardiac functions

  • LVEF ≥50% (with MUGA scan or TTE)
  1. 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).

  1. 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)

  2. 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.

  3. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joon Jeong, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT04817540
Other Study ID Numbers:
  • 3-2021-0026
First Posted:
Mar 26, 2021
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Apr 27, 2021