Phase II study of tri-weekly administration of nanoparticle albumin-bound-paclitaxel for first-line chemotherapy in advanced and metastatic HER2- negative breast cancer

Phase II study of tri-weekly administration of nanoparticle albumin-bound-paclitaxel for first-line chemotherapy in advanced and metastatic HER2- negative breast cancer - Phase II study of Nab-paclitaxel treatment in HER2-negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007342

Enrollment

Registered

2012-02-27

Start date

2011-09-01

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

advanced and metastatic breast cancer

Interventions

Nab-paclitaxel 250 mg/m2 (i.v.) x every 3 weeks x 6 cycles or more

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1 Histological diagnosis of invasive and HER2-negative breast cancer 2 Stage IV or recurrent breast cancer 3 No prior chemotherapy after diagnosis of metastases 4 Measurable disease 5 No treatment with radiation within 7 days or endocrine therapy within 14 days of the study. Any kind of primary chemotherapy or adjuvant chemotherapy at the diagnosis of operable breast cancer 6 Acceptable organ condition 7 ECOG PS of 0 to 2 8 A written informed consent

Exclusion criteria

Exclusion criteria: Past history of viral B or C hepatitis Interstitial pulmonary disease or its past history Other invasive cancer

Design outcomes

Primary

Measure	Time frame
Tumor response rate	—

Secondary

Measure	Time frame
safety overall survival progression-free survival adverse events QOL	—

Countries

Japan

Contacts

Public ContactHirotsugu Isaka

Kyorin University Hospital Department of Breast Surgery

imoto@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

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