A pilot study of neoajuvant fluorouracil, epirubicin and cyclophosphamide followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer.

A pilot study of neoajuvant fluorouracil, epirubicin and cyclophosphamide followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer. - Neoajuvant FEC followed by paclitaxel plus high dose toremifene in women with node positive or high-risk breast cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003091

Enrollment

Registered

2010-01-26

Start date

2009-11-01

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

Primari breast cancer

Interventions

high dose toremifene 120mg/body

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Case signedinformed consent of the patients for the registration 2.Case confirmed by pathological diagnosis 3.Postmenopausal women with breast cancer 4.Node positive, high-risk, stage II breast cancer 5.Case that survival more than 6 months is anticipated 6.Case with PS 0 or 1 7.Case with measurable primary lesions 8.Case with a satisfactory function of a heart/liver/kidney/bone marrow ant to satisfy the next condition Hb:more than 8g/dl AST(GOT), ALT(GPT):less than 2.5 times of the normal value upper limit of the institution WBC:more than 4000/mm3 Plt:more than 100000/mm3 TB:less than 1.5mg/dl Crea:less than 1.5 times of the normal value upper limit of the institution

Exclusion criteria

Exclusion criteria: 1.Case with active other malignancies 2.Case with past history of drug allergy or hypersensitivity 3.Case during pregnancy or lactation 4.Case with adverse myelosuppression 5.Case with infectious disease 6.Case with inflammatory breast cancer 7.Case with metastatic breast cancer 8.Case judged inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
pathological response rate.	—

Secondary

Measure	Time frame
clinila response rate, adverse events, breast concerving rate.	—

Countries

Japan

Contacts

Public ContactTatsuko Kawasaki

Fukushima Medical University School of Medicine Department of Breast Surgery

024-547-1259

Outcome results

None listed

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