Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer

Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer - Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009152

Enrollment

Registered

2012-10-19

Start date

2012-09-01

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

Breast cancer

Interventions

4 cycles of FEC followed by 4 cycles of nab-paclitaxel FEC Epi-ADM 90 mg/m2 and CPA 600 mg/m2 iv,day 1 every 3 weeks Nab-paclitaxel Nab-paclitaxel:100mg/m2 intravenously administred on day 1,8

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed Breast cancer 2. Clinical stage2-4 3. Expected to radical cure by operation and neoadjuvant chemotherapy 4. Has measurable region 5. Age >=20 6.No prior surgery, radiation, chemotherapy and endcrinethrapy 7.Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC >= 3500 /mm3 and <= 12,000 /mm3 Neu >= 2000 / mm3 Plt >= 100,000/mm3 T-Bil <= 2 times ULM AST<= ULNx2 ALT<= ULNx2 Creatinin <=1.5 mg/dL Ccr <=50 ml/min 8.Performance status 0-1 9. Oral administration is available 10.Written IC

Exclusion criteria

Exclusion criteria: 1.Inflammatory and bilateral breast cancer 2.Active another cancer 3.History of hypersensitivity reaction 4. Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure 5. Contraindication to the study drugs 6. Has active infection or fever which suspected of infection 7.During administration of flucytosine, phenytoin, warfarin potassium 8.Physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Pathological response rate,Rasponse rate,Safty	—

Countries

Japan

Contacts

Public ContactShinsaku Kanazawa

Toho University Omori Medical Center Breast and Endocrine Surgery

sg0713sk@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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