Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)

Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801) - Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001736

Enrollment

Registered

2009-02-27

Start date

2008-09-01

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

Primary breast cancer

Interventions

Paclitaxel 80mg/m2 every week for 12 cycles. 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles. Operation is to be offered to the patients with br

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Histologicaly-proven primary resectable breast cancer with a tumor size of >=1cm and clinical stage of <=IIIA 2. No history of chemotherapy 3. No history of surgery, radiotherapy, hormonal therapy against breast cancer 4. ECOG PS 0, 1 5. Sufficient organ function 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe medical conditions 2. Suspected infectious disease 3. Alergy to clemohol EL 4. Severe peripheral neuropathy 5. Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Safety Clinical efficacy Overall survival Disease free survival Breast-conserving rate	—

Countries

Japan

Contacts

Public ContactKazuo Tamura

Kyushu Breast Cancer Study Group Executive office

npo@chotsg.com092-406-4166

Outcome results

None listed

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