Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer

Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer - Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer (GENESIS-BC-01)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000413

Enrollment

109

Registered

2006-05-01

Start date

2006-03-01

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

Arm A: Patients do not utilize genetic diagnosis for sensitivity to paclitaxel and receive primary chemotherapy with paclitaxel (Patients are randomized to arm A or B with ratio 1 to 4.) Arm B: Patien

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Histologically confirmed breast cancer with tumor size 3cm and more in stageIIA-StageIIIB. Operable case. Age below 70. PS 0 or 1. Life expectancy 6 months and more. WBC:4,000/micro L and more or ANC:2,000/micro L and more. Platelet:100,000/micro L and more. Hemoglobin:9g/dl and more. AST(GOT),ALT(GPT):twice of an upper limit of normal value and less. Serum total bilirubin:1.5 mg/dl and less. BUN,Creatinine:an upper limit of normal value and less. ECG within normal limit. Given written consent.

Exclusion criteria

Exclusion criteria: Non invasive or microinvasive breast cancer. Stage IIIC, IV. Inflammatory breast caner. Male breast cancer. Previously treated with chemotherapy, hormone therapy or radiotherapy. Active double cancer. Serious complication (infection, cardiac disease, pulmonary fibrosis interstitial pneumonitis, bleeding). Hepatitis type B and its carrier. Uncontrolled diabetes. Heavy history of drug allergy. History of allergic reaction to drugs using the vehicle Cremophor. Pregnant, nursing or willing to be pregnant. Inadequate to entry judged by investigators.

Design outcomes

Primary

Measure	Time frame
Accuracy of prediction system of sensitivity: Elucidate a population of patients who are sensitive to paclitaxel by performing quantitative RT-PCR on about 50 genes before administration of paclitaxel. Evaluate pathological response by paclitaxel in patients who are diagnosed as positive sensitivity and compare those in patients who do not receive sensitivity testing. Improvement of pathological response rate is judged as high accuracy of prediction system for sensitivity	—

Measure

Time frame

Accuracy of prediction system of sensitivity: Elucidate a population of patients who are sensitive to paclitaxel by performing quantitative RT-PCR on about 50 genes before administration of paclitaxel. Evaluate pathological response by paclitaxel in patients who are diagnosed as positive sensitivity and compare those in patients who do not receive sensitivity testing. Improvement of pathological response rate is judged as high accuracy of prediction system for sensitivity

—

Secondary

Measure	Time frame
Examine the influence of genetic diagnosis on pathological complete response rate, clinical response rate, breast conserving rate, disappearance rate of axillary node metastasis, distant-metastasis free survival, disease free survival and overall survival. Examine the association between genetic polymorphism and adverse events by chemotherapy	—

Countries

Japan

Contacts

Public ContactDaigo Syouji

Cancer Institute Hospital, Japanese Foundation for Cancer Research Department of Medical Oncology

03-3520-0111

Outcome results

None listed

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