A phase II study of TSU-68 in patient with metastatic breast cancer previously treated with an anthracycline.

A phase II open label randomized multicenter trial of TSU-68 in combination with docetaxel versus docetaxel alone in patients with metastatic breast cancer previously treated with an anthracycline.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221367

Enrollment

Registered

2011-01-25

Start date

2011-01-25

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 : TSU-68, Docetaxel INN of investigational material : TSU-68:orantinib, docetaxel Therapeutic category code : 429 Other antitumor agents Dosage and Adminis

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Signed, written informed consent. (2) Eastern Cooperative Oncology Group (ECOG) performance status of =< 2. (3) Non-pregnant, non-breastfeeding.

Exclusion criteria

Exclusion criteria: (1) Symptomatic brain metastasis or inflammatory breast cancer. (2) Any significant disease that, by the Investigator's opinion, should exclude the patient from the study. (3) History of drug abuse within 6 months prior to the start of study treatment

Design outcomes

Primary

Measure	Time frame
Progression free survival RECIST (ver. 1.0)	—

Secondary

Measure	Time frame
Overall response rate, Overall survival, Safety RECIST (ver. 1.0), CTCAE (ver. 3.0)	—

Outcome results

None listed

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