Whole Genome sequencing study Strategic Cohort Breast Cancer

Optimization of preoperative chemotherapy for breast cancer using whole genome sequencing -prediction of pathological complete response and exploration of a novel target for patients with non-pathological complete response-

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030250152

Enrollment

240

Registered

2025-06-05

Start date

2023-12-15

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

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are 18 years of age or older at the time of consent 2. Patients who have been fully informed of the details of this study and have given their written consent. 3. Histologically or cytologically confirmed invasive breast cancer 4. Clinical stage II-III breast cancer 5. Immunohistochemistry have shown hormone receptor-positive or negative breast cancer 6. Immunohistochemistry have shown HER2-negative breast cancer 7. Patient is scheduled to receive preoperative therapy with anthracycline, taxane with or without pembrolizumab, etc. 8. Performance status (PS) is 0-2 by ECOG criteria 9. Organ function is preserved

Exclusion criteria

Exclusion criteria: 1. Patients with a history of invasive malignancy within the past 3 years from the time consent was obtained. 2. Have an active infection requiring systemic treatment. 3. Have poorly controlled diabetes mellitus or hypertension. 4. Patients with unstable angina, myocardial infarction within 6 months, or clinically significant arrhythmia requiring treatment. 5. Congestive heart failure, poorly controlled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy consistent with New York Heart Association (NYHA) Classification II or higher. 6. Receiving continuous systemic administration of steroids " exceeding 10mg/day of prednisolone equivalent"or immunosuppressive agents. 7. Other cases deemed inappropriate by the physician in charge.

Design outcomes

Primary

Measure	Time frame
Identify genomic and immunological factors that correlate with pCR in preoperative treatment	—

Secondary

Measure	Time frame
Identify genomic and immunological candidate factors that can serve as the basis for selecting postoperative therapies in breast cancer patients who do not achieve pathological complete response (non-pCR) after neoadjuvant therapy.	—

Contacts

Public ContactYukinori Ozaki

Cancer Institute Hospital of Japanese Foundation for Cancer Research

yukinori.ozaki@jfcr.or.jp+81-3-3520-0111

Outcome results