A phase 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer

A phase 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer - A phase 2 study of weekly Nab-Paclitaxel followed by FEC as primary therapy for operable breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007510

Enrollment

Registered

2012-03-16

Start date

2012-04-01

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

Four courses of weekly Nab-pacltaxel is followed by 4 courses of FEC100. [Weekly Nab-paclitaxel] Nab-paclitaxel at a dose of 100mg/m2 is administered on days 1, 8, and 15, of a 28 day cycle, for

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed primary breast cancer. 2. Age 20 or over. 3. Clinical T1-3, N0-2, M0 cases. 4. Curative by primary chemotherapy and surgery. 5. Performance status (ECOG) 0 or 1. 6. Has measurable lesion. 7. With no prior surgery, radiation, chemotherapy, nor hormonal therapy. 8. The below criteria met within 14 days prior to therapy; (1) WBC between 4,000/mm3 and 12,000/mm3. (2) Granulocyte count 2,000/mm3 or over. (3) Platelet count 100,000/mm3 or over. (4) Hb 9.0 g/dl or over. (5) Serum total bilirubin 1.5 mg/dL or under. (6) AST and ALT below 2.5 times the institute upper limit. (7) Serum creatinine 1.5 mg/dL or under. (8) Cardiac function: left ventricle ejection fraction 55 % or over by cardiac sonography or MUGA scan. (9) EKG within normal limits. 9. Written consent obtained from the patient.

Exclusion criteria

Exclusion criteria: 1. Cases with prior history of hypersensitivity reaction to the drugs or solvents (e.g. albumin, paclitaxel) used in this protocol. 2. Bilateral breast cancer cases. 3. Cases with inflammatory breast cancer. 4. Male breast cancer cases. 5. Cases with active secondary malignancy (current secondary malignancy or other malignancy within 5 years) . 6. Cases with conditions with the potential to compromise the planned treatment, such as cases with active infection, diarrhea, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, uncontrolled angina and myocardial infarction within 6 months, heart failure, and other serious conditions. 7. Pregnant or breast feeding cases. 8. Cases with pulmonary fibrosis or interstitial pneumonia. 9. Cases with severe myelodepression, renal or liver dysfunction. 10. Cases in which the treating physician deems inappropriate to be entered into this study for other reasons.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate.	—

Secondary

Measure	Time frame
Pathological complete response rate by breast cancer subtype, breast conservation rate, frequency of adverse effects.	—

Countries

Japan

Contacts

Public ContactNobumitsu Tamaki

Nahanishi Clinic Division of Surgery

98-858-5557

Outcome results

None listed

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