Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer

Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer - Neoadjuvant Paclitaxel/Bevacizumab followed by FEC therapy for triple negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010228

Enrollment

Registered

2013-03-13

Start date

2013-03-13

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 Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) invasive breast cancer by needle biopsy 2) operable primary breast cancer (cStage I~IIIA) 3) ER(-), PgR(-) 4) HER2 negative (IHC 0, 1+ or FISH -) 5) P.S. = 0~1 6) measurable lesions 7) preserving the functions of bone marrow, heart, liver, and kidney 8) written informed consent

Exclusion criteria

Exclusion criteria: 1) drug allergy 2) severe complications (malignant hypertension, congestive heart failure, coronary heart disease, myocardial infarction (onset within 6 months), arrhythmia (treated), infectious disease, bleeding tendency, etc) 3) feber, infection 4) peripheral neuropathy 5) pleural effusion, pericardial effusion 6) active double cancer 7) inflammatory breast cancer 8) male breast cancer 9) pregnancy 10) severe edema 11) interstitial pneumonia, fibrous lung disease 12) steroid-using patients 13) psychosomatic disease 14) active digestive ulcer 15) unsuitable patients

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Pathological complete response rate, Breast-conserving rate, Overall Survival, Relapse-free survival, Safety	—

Countries

Japan

Contacts

Public ContactKoiciro Tsugawa

St. Marianna University School of Medicine Department of Surgery, Division of Breast and Endocrine Surgery

koitsuga@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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