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Evaluation Study for its Clinical Utility of Gene Prognostic Signature MammaPrint for Early-Breast Cancer

Evaluation Study for its Clinical Utility of Gene Prognostic Signature MammaPrint for Early-Breast Cancer - Utility of Gene Prognostic Signature MammaPrint for Early-Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002834
Enrollment
50
Registered
2009-12-03
Start date
2009-10-01
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

Breast Cancer

Interventions

* For patients identified as low risk by both MammaPrint and conventional method, no adjuvant chemotherapy will be applied. * For patients identified differently by MammaPrint and conventional method

Sponsors

Department of Breast and Endocrine Surjery, Juntendo University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age between 20 to 75 2. ECOG performance status 0-1 3. Cardiac: Ejection fraction ≥ 60% is needed (estimated by echocardiography) 4. Hepatic: AST & ALT ≤*2.5 upper normal limit, Total bilirubin ≤2.0 mg/dL 5. Invasive breast cancer, Stage I & II, by core needle biopsy 6. Lymph node negative patient (N0) by palpation and by ultrasound 7. Tumor size ≥1.5 cm (preferably ≥2.0 cm) 8. Able to collect fresh samples (No formalin fixation) 9. Able and willing to give valid written informed consent 10. No complication

Exclusion criteria

Exclusion criteria: 1. Developed malignancy except carcinoma in situ 2. Received Neo-adjuvant therapy treatment

Design outcomes

Primary

MeasureTime frame
Evaluation to decide breast cancer adjuvant therapy and treatment by applying MammaPrint to each patient to see if prognosis by gene expression profiling.

Countries

Japan

Outcome results

None listed

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