Efficacy and feasibility study of docetaxel + capecitabine followed by FEC neoadjuvant therapy for hormone receptor positive and HER2 negative breast cancer

Efficacy and feasibility study of docetaxel + capecitabine followed by FEC neoadjuvant therapy for hormone receptor positive and HER2 negative breast cancer - docetaxel + capecitabine followed by FEC neoadjuvant therapy for triple negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013274

Enrollment

Registered

2014-02-25

Start date

2012-11-20

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

Neoadjuvant Chemotherapy Docetaxel + Capecitabine q 3wks x 3 cycles follwed by FEC q 3wks x 3 cycles

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1 Histologically confirmed ER and PgR negative, HER2 negative invasive breast cancer. 2 ECOG PS 0-1 3 Tumor size >=1cm,N0-2, M0 4 Adequate visceral function 1) WBC >=3000/mm3 2) Hb >=8.0g/dL 3) Platelet >=100000/mm3 4) Total bilirubin <=1.5mg/dL 5) AST/ALT <= x 2.5 upper normal limits 6) serum Cr <=1.5mg/dL 5 Written informed consent

Exclusion criteria

Exclusion criteria: 1 HER2 positive 2 Pregnant or breast feeding 3 Severe infectious disease 4 Active another cancer 5 Hypersensitivity for 5FU, docetaxel or polysolvate 6 Investigator's judgement of inappropriateness for perticipation

Design outcomes

Primary

Measure	Time frame
pathological CR rate, Feasibility, Overal response rate	—

Secondary

Measure	Time frame
Adverse effects	—

Countries

Japan

Contacts

Public ContactTsutomu Takashima

Osaka City University Graduate School of Medicine Surgical Oncology

tsitomu-@rd5.so-net.ne.jp06-6645-3838

Outcome results

None listed

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