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Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy

Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy - Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000014479
Enrollment
100
Registered
2014-07-04
Start date
2014-06-27
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

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: A patient planning to undergo breast biopsy with written informed consent because breast cancer was clinically suspected 1. Lesion over 2 cm tumor size 2. Age >= 20 and < 75 3. Performance status 0-1 4. Normal cardiac function (EF>55% by ultrasound) 5. Normal liver functions (AST/ALT <= upper limit of normal * 2.5 and T.bil <= 2.0mg/dl) 6. Normal kidney function(Cr <= 1.5mg/dl) 7. Without distant metastatic lesions, basically, except the for stage IV without lethal metastases, and scheduled to undergo local control surgery after chemotherapy Patients with neoadjuvant chemotherapy are as follows: (1) Fine needle aspiration cytology for axillary lymph nodes proven to be positive for cancer cells or axillary lymph node positivity is highly suspected clinically (2) Breast conserving operation is expected with neoadjuvant chemotherapy, regardless of nodal status (3) Triple negative or HER 2 type breast cancer according to core needle biopsy results, regardless of nodal status (4) Judged to have an indication for PST by the doctor in charge

Exclusion criteria

Exclusion criteria: 1. Ductal carcinoma in situ 2. Any past history of malignant disease

Design outcomes

Primary

MeasureTime frame
To compare RNA expressions between breast cancers with complete response to neoadjuvant chemotherapy and tumors with non-complete responses for each subtype

Secondary

MeasureTime frame
To compare RNA expressions in each breast cancer subtype

Countries

Japan

Contacts

Public ContactHyonmi Sai

Juntendo University Breast Oncology

shyonmi@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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