Evaluation of efficacy and safety of Abraxane for metastatic breast cancer

Evaluation of efficacy and safety of Abraxane for metastatic breast cancer - Abraxane Phase II study for metastatic breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006158

Enrollment

Registered

2011-08-15

Start date

2011-04-01

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

Abraxane: 260mg/m2, iv, day 1 Every 3 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed metastatic breast cancer. 2. Age are more than 19 years old 3. within withiin 1 prior treatment for metastatic breast cancer. 4. With evaluable leasion 5. Performance statu is 0,1,2. 6. Required baseline laboratory data. (within 14 days of registration) WBC > 4,000 /mm3 or Neu > 2,000/mm3 PLT > 100,000 /mm3 Hb > 9.0 g/dL ALT and AST < ULNx2.5 ALT and AST < ULNx2.5 T-Bil < 1.5mg/dL serum creatine < 1.5mg/dL 9. Expected survival time: more than 3 months. 10.Written informed- consent

Exclusion criteria

Exclusion criteria: 1. With history of hypersensitivity reaction for paclitaxel and/or Albumin. 2. With severe complications. 3. Pregnant or nursing women. 4. With widespread liver metastases or with dyspnea in pulmonary lymphangitis. 5. With severe complications. 6. With brain metastasis. 7. with uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease. 8. With pulmonary fibrosis or pneumonitis. 9. With dyspnea at rest. 10. With pleural effusion, ascites, pericardial effusion. 11. Doctor's decision not to be registered to this study.

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Response rate Progression-free survival	—

Countries

Japan

Contacts

Public ContactYutaka Yamamoto

Kumamoto university, Graduate School ofMedical Sciences Department of Breast and Endocrine surgery

096-373-5521

Outcome results

None listed

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