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A phase II study of pemetrexed in patients pretreated with an anthracycline, a taxane, and capecitabine for advanced breast cancer.

A phase II study of pemetrexed in patients pretreated with an anthracycline, a taxane, and capecitabine for advanced breast cancer.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TNC-09000349
Enrollment
Unknown
Registered
2009-03-07
Start date
2009-02-20
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced breast cancer

Interventions

patient:pemetrexed

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age is from 18-65 years old; 2. Histological/cytological confirmation of breast cancer patient who stage IIIB-IV, and pre-treated with an anthracycline, a taxane, and capecitabine; 3. Patient with measurable disease as per RECIST criteria; 4. untreated with pemetrexed; 5. ECOG PS: 0-2; 6. normal marrow function: PLT>100*10^9/L, Hb> 10g/dL, neutrophilic granulocyte>1.5*10^9/L, normal renal function: serum creatinine clearance >=45ml/min. Normal liver function: bilirubin<1.5 ULRR and AST/ALT<2ULRR if no demonstrable liver metastasases or bilirubin<1.5 ULRR and AST/ALT<5ULRR in presence of liver metastasases; 7. Provision of informed consent.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactation; 2. hypersusceptibility to pemetrexed or excipient; 3. uncontoled heart, liver or renal disease; 4. difficult to be controlled infection; 5. psychosis or disorientation; 6. can not be follow-up; 7. brain metastasases with symptom.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
PFS;response phase;survival;

Countries

China

Contacts

Public ContactXiaojia Wang
wxj88851@yahoo.com.cn+86 0 13906500190

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026