Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study

Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study - Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study(PST0402)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000265

Enrollment

Registered

2005-10-16

Start date

2004-10-01

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

chemotherapy:FEC(fluoraouracil, epirubicin and cyclophosphamide)followed by P+H(weekly Paclitaxel+Trastuzumab)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Histologically confirmed mastocarcinoma except for non-invasive carcinoma T1-3N+M0/T2-3N-M0 HER2 positiveby fluorescence in situ hybridization(FISH) or showed 3+ or 2+ overexpression by immunohistochemistry No prior therapy for breast cancer No operation/Performance status 0 or 1 Adequate hematologic,renal,hepatic and cardiac function Written informed consent

Exclusion criteria

Exclusion criteria: severe complication suspicious of infection Hypersensitivity for polyoxyethylene castor oil (Cremophor EL) containing drugs grade 3 or 4 peripheral neuropathy Male breast cancer Pregnant or lactating women Doctor' s decision for exclusion

Design outcomes

Primary

Measure	Time frame
pathological complete rseponse rate	—

Secondary

Measure	Time frame
clinical response, treatment compliance, breast-conserving rate, safety, overall survical, disease-free survival	—

Countries

Japan

Contacts

Public ContactNorikazu MASUDA

Breast Cancer PST Study Group Executive Office

nmasuda@alpha.ocn.ne.jp06-6942-1331

Outcome results

None listed

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