A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer (JBCRG-13)

A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer (JBCRG-13) - JBCRG-13

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003570

Enrollment

Registered

2010-05-10

Start date

2010-04-10

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

Operable triple negative or low hormone receptors/HER2 negative primary breast cancer

Interventions

Metronomic PCX + FEC: 4 cycles of metronomic PCX therapy* followed by 4 cycles of FEC therapy** * metronomic PCX regimen: Paclitaxel 80mg/m2 iv day1,8,15 weekly Cyclophosphamide 50mg/body po day

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Female primary breast cancer patients who are diagnosed as triple negative or low hormone receptors/HER2 negative [T1C-3 N0 M0 (> 1cm)/ T1-3 N1 M0: at first diagnosis]. 2) Histological confirmed invasive breast cancer by biopsy. 3) Absent or low expression of Estrogen receptor(ER) and Progesterone receptor(PR) (IHC < 10%) and HER2 negative (IHC 1+/0 or IHC 2+/FISH-). 4) Age between 20 years old and 70 years old. 5) Measurable region. 6) Adequate major organ function; a) WBC >= 4,000/mm3, or ANC >= 2,000/mm3 b) PLT >= 100,000/mm3 c) Hb >= 9.0 g/dL d) AST, ALT <= 2.5 x ULN e) T. Bil or direct Bil <= 1.5 x ULN f) Serum Cr. <= 1.5 x ULN g) Creatinine clearance >= 50mL/min h) Nomal ECG 7) ECOG performance status (P.S.): 0 and 1. 8) No previous treatments for breast cancer. 9) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Prior chemotherapy or endocrine therapy in the past 5 years. 2) Active double cancer. 3) Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 4) Male patient. 5) Infection or suspected infection. 6) Serious cardiac disorder or preexisting cardiac disease. 7) Uncontrolled diabetes. 8) Gastrointestinal ulceration or gastrointestinal bleeding. 9) Other serious complication. 10) History of drug-hypersensitivity 11) Ineligible based on decision of an investigator.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Overall response rate, Safety, Breast conservation rate, Overall survival, Disease-free survival	—

Countries

Japan

Contacts

Public ContactKatsumasa Kuroi

Japan Breast Cancer Research Group (JBCRG) Administrative office

office@jbcrg.jp+81-3-6264-8873

Outcome results

None listed

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