An early phase II study of TSU-68 in combination with docetaxel in patients with advanced and metastatic breast cancer progressing anthracycline containing regimen.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221143

Enrollment

Registered

2010-07-01

Start date

2010-07-01

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

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) A patient who herself agreed in writing to become a study subject for this clinical study. 2) A patient at the age of not less than 20 years and not more than 75 years. 3) A woman who was histologically or cytologically diagnosed as breast cancer. 4) A patient whose measurable lesion was identified by the objective data. 5) A patient who has at least one lesion which satisfied the criteria based on the data within 30 days before start of this clinical study. 6) A patient who was judged irresponsive to anthracycline drugs. 7) A patient who has not been treated with a taxane drug. 8) A patient with physiologically well maintained compensatory functions, especially the function of parenchymal organs including bone marrow, liver, kidney and heart. 9) A patient who can receive oral administration. 10) A patient who is expected to live for sufficient period of time. 11) A patient whose WHO's performance status (P.S.) is 0-2.

Exclusion criteria

Exclusion criteria: 1) A patient who was affected by pretreatment. 2) A patient with a large amount of pleural effusion, ascites or pericardial fluid that requires drainage to remove the fluid or affects respiratory or circulatory kinetics. 3) A patient who has cerebral lesion with clinical symptoms. 4) A patient who has active infection. 5) A patient who has serious complication. 6) A patient who has the experience of serious thrombosis. 7) A patient who has the experience of serious anaphylaxis to the polysorbate 80-containing preparation. 8) A patient who routinely requires oral or intravenous steroids. 9) A patient who has colon disorder with active inflammation. 10) A woman who wishes a baby, pregnant woman and a woman in a lactation period.

Design outcomes

Primary

Measure	Time frame
Best overall response rate RECIST guideline	—

Secondary

Measure	Time frame
Adverse event, Adverse drug reaction, Clinical benefit rate NCI-CTC Ver 2.0, RECIST guideline	—

Outcome results

None listed

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