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A prospective phase II randomized clinical trial of docetaxel combined with lobaplatin and docetaxel combined with gemcitabine in the treatment of recurrence or metastasis breast cancer

A prospective phase II randomized clinical trial of docetaxel combined with lobaplatin and docetaxel combined with gemcitabine in the treatment of recurrence or metastasis breast cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005633
Enrollment
Unknown
Registered
2014-11-26
Start date
2014-11-01
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

Breast Cancer

Interventions

1:75mg/m2Docetaxel+30mg/m2Lobaplatin
2:75mg/m2Docetaxel+gemcitabine

Sponsors

Guizhou Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Not less than 18 years old, female patients; 2. With the diagnosis of Breast cancer confirmed by pathological or cytology tests; 3. Recurrent or Metastatic breast cancer; 4. With measurable tumor focus; 5. KPS more than 70; 6. Life expectancy longer than 3 months; 7. Laboratory parameters: Bone marrow function: ANC more than 1.5*10^9/L; PLT more than 100*10^9/L; HB more than 90g/L; Hepatic function: STB and CB less than ULN*1.5; ALT and AST less than ULN*2.5 (without liver metastasis), or less than ULN*5 (with liver metastasis); Renal function: Cr less than ULN; Ccr more than 60 ml/min (Cockcroft-Gault); 8. Keep contraception during the administration and 6 months later; not breastfeeding; 9. Voluntary to participate and sign informed consent document.

Exclusion criteria

Exclusion criteria: 1. Allergic to chemotherapy drugs used in the trial; 2. The Blood and the function of liver and kidney abnormalities; 3. Poor compliance; 4. Other cases, such as serious violations of the scheme; 5. Other patients that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The disease control rate;

Contacts

Public ContactRan Li

Guizhou Cancer Hospital

ranli171@hotmail.com+86 13984375768

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026