A Phase I Study of weekly ABI-007 in Combination with TS-1 in Patients with Metastatic Breast Cancer

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221553

Enrollment

Registered

2011-09-01

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

Metastatic breast cancer

Interventions

investigational material(s) Generic name etc : ABI-007 INN of investigational material : paclitaxel Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Adminis

Cycle 1: from Day 1 morning through Day 14 evening, Cycle 2 - : from Day 1 evening through Day 15 morning.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: - Patient has no prior chemotherapy or one for metastatic breast cancer. No prior chemotherapy of Taxanes or TS-1 for metastatic breast caner. - Patient has no over-expressed HER2 for IHC or FISH.

Exclusion criteria

Exclusion criteria: - Patient has recurrent disease within 12 months following the end of neo-adjuvant or adjuvant chemotherapy with a Taxane-containing regimen.

Design outcomes

Primary

Measure	Time frame
Safety CTCAE (ver.4.0)	—

Secondary

Measure	Time frame
Pharmacokinetics, Efficacy RECIST (ver.1.1)	—

Outcome results

None listed

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