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Predictive Value of Genetic Analysis for Pathological Complete Response to Preoperative Treatment in HER2-Positive HR-Negative Early Breast Cancer

Predictive Value of Genetic Analysis for Pathological Complete Response to Preoperative Treatment in HER2-Positive HR-Negative Early Breast Cancer - PASSION trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028065
Enrollment
200
Registered
2017-09-01
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive HR-negative breast cancer

Interventions

Trastuzumab-containing chemotherapy followed by whole breast irradiation, then surgery. Chemotherapy is sequential treatment of anthracyclines and taxanes with tarastuzumab or TCH. Select one of the
AC, EC, FAC, FEC and Dose dense AC Select one of the following taxane with tarastuzumab regimens
PTX/T-mab and DTX/T-mab

Sponsors

Japan Agency for Medical Research and development
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria: 1. Active other malignancies 2. Bilateral breast cance 3. Multicentric tumors 4. History of congestive heart failure or myocardial infarction, arrhythmia or heart valvular disease requiring treatment 5. Clinically significant infection 6. Pregnant or breast-feeding women, women of childbearing potential 7. Diabetes uncontrolled or requiring insulin 8. Systemic sclerosis or systemic lupus erythematosus 9. Systemic use of steroids or immunosuppressive agents 10. Unsuitable mental status for participation 11. Ineligible based on decision of an investigator

Design outcomes

Primary

MeasureTime frame
pCR rate in HSD17B4-hypermethylated breast cancer

Countries

Japan

Contacts

Public ContactHiromi Shinano

Comprehensive Support Project Oncological Research of Breast Cancer Administration Office

office-bc@cspor-bc.or.jp03-5294-7288

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026