Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer

Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer - Randomized phase II study of preoperative systemic chemotherapy of carboplatin/weekly paclitaxel followed by CEF versus weekly paclitaxel followed by CEF for operable HER2-negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003355

Enrollment

220

Registered

2010-03-22

Start date

2010-03-01

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

Stage II and IIIA breast cancer

Interventions

CBDCA/wPTX arm Carboplatin AUC5/paclitaxel 80mg/m-2 (day 1, 8, 15) /q3wks x 4courese, followd by CEF(cyclophosphamide/epirubicin/5-fluorouracil 500/100/500mg/m-2/q3wks) x 4courses wPTX arm Paclitaxe

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Eligible patients has previously untreated, unilateral, histologically confirmed, invasive, non-inflammatory, breast carcinoma. Histologic confirmation of invasive cancer is performed by core needle biopsy (CNB). HER2 is negative. Patients with a tumor &#8805; 2.1 cm at the largest dimension by ultrasonography, or < 2.1 cm with axillary lymph node metastasis clinically diagnosed as positive, are eligible (clinical stage II and IIIA). Patients with axillary nodes enlarged by > 1cm at the largest dimension according to ultrasonography are considered node positive. Age is between 18 and 70 years.ECOG performance status is 0 to 2.Adequate bone marrow function. Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients during pregnancy or lactation 2) Active infectious disease 3) History of hypersensitivity for Cremophor&reg; EL(polyoxethylated castor oil) 4) Interstitual pneumonia or lung fibrosis 5) HBs antigen positive 6) Uncontrolled diabetes

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate, which is defined as the absence of viable invasive tumor in both the breast and the axillary nodes, or residual ductal carcinoma in situ (DCIS) in breast and no viable invasive tumor in the axillary nodes.	—

Secondary

Measure	Time frame
1) Disease-free survival 2) Clinical response rate 3) Adverse events 4) Breast-conservation rate	—

Countries

Japan

Contacts

Public ContactMasashi Ando

National Cancer Center Hospital Breast and Medical Oncology

03-3542-2511

Outcome results

None listed

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