Pilot study of low-dose Nab-paclitaxel as adjuvant chemotherapy in patients with breast cancer

Pilot study of low-dose Nab-paclitaxel as adjuvant chemotherapy in patients with breast cancer - Pilot study of low-dose Nab-paclitaxel as adjuvant chemotherapy in patients with breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012047

Enrollment

Registered

2013-10-16

Start date

2013-09-01

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

4 cycles of low-dose Nab-paclitaxel Low-dose nab-Paclitaxel (HER2 negative) Nab-Paclitaxel(80mg/m2) day1,8,15, every 4 weeks (HER2 positive) Nab-Paclitaxel(80mg/m2) day1,8,15 Trastuzumab 2

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Cytological confirmed breast cancer 2) Curatively resected 3) Age 20 or over 4) No prior therapy(except for endocrine therapy,surgery,radiation) 5) Adequate function of important organs (within 14 days before registaration) 1. WBC: >=3,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T-Bil <= ULN x 2.5 6. AST <= ULN x 1.5 7. ALT <= ULN x 1.5 8. Creatinin <= 1.5mg/dL 6) ECOG performance status 0-1 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity reaction 2) Active double cancer 3) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure. 4) Severe mental disorder 5) Sever bone marrow suppression, renal dysfunction, liver dysfunction 6) Has watery diarrhea 7) Active infection or potentiality infection 8) History of hypersensitivity for albumin 9) Grade2 or grater peripheral neuropathy 10) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 11) Judged ineligible based on physicians' decision

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Feasibility,Relative dose intensity,Disease Free Survival	—

Countries

Japan

Contacts

Public ContactHirohito Seki

Kitasato University Kitasato Institute Hospital Breast Center

hirosuke@blue.ocn.ne.jp03-3444-6161

Outcome results

None listed

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