The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306)

The safety and efficacy trial of primary chemo-radiotherapy for stage I to IIIA breast cancer (JCOG0306) - The safety and efficacy trial of primary chemo-radiotherapy for the early breast cancer (JCOG0306)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000114

Enrollment

104

Registered

2005-09-05

Start date

2004-07-01

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

stage I to IIIA breast cancer

Interventions

Doxorubicine+cyclophosphamide followed by paclitaxel, radiotherapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Core needle biopsy-proven invasive breast cancer (female only) 2) Clinical stage I-IIIA 3) 5cm >= tumor diamiter confirmed by breast ultrasound sonography >= 2cm 4) All tumors exist within planning target volume of boost radiation, if multifocal lesions exist in the same breast 5) Patients without bilateral breast cancer 6) Age >= 20, <= 70 7) PS(ECOG) 0-1 8) Previously untreated with chemotherapy or radiotherapy 9) Adequate organ function 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Current history of malignant neoplasms except for curative carcinoma in situ or mucosal carsinoma 2) Pregnant or lactating women or women of childbearing potential 3) Active infectious diesase 4) Past histry of allergic reaction to cremophor EL(polyoxethylated castor oil) or polysorbate 5) Interstitial pneumonia or fibroid lung reveald by chest x-ray 6) Poorly controlled or insulin dependent diabetes mellitus 7) Psychological disease or psychological symptom that interferes with entering this trial

Design outcomes

Primary

Measure	Time frame
pathological complete response rate	—

Secondary

Measure	Time frame
toxicity, clinical complete response rate, breast conserving rate, relapse free survival, overall survival	—

Countries

Japan

Contacts

Public ContactHirofumi Mukai, MD

JCOG0306 Coordinating Office Divison of Oncology and Hematology, National Cancer Center Hospital East

JCOG_sir@ml.jcog.jp

Outcome results

None listed

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