Status:
UNKNOWN
The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
Lead Sponsor:
Zhiyong Yu
Conditions:
Breast Cancer
Chemotherapy Effect
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Worldwide, breast cancer is the most incident and prevalent cancer among women. Despite advances in the treatment of advanced breast cancer (ABC) during the past decade, adjuvant systemic therapy has ...
Detailed Description
The trial is designed to help us to choose the maintain treatment regiment for the patients with effective first-line salvage therapy. After inorelbine and gemcitabine (NG) or vinorelbine and platinum...
Eligibility Criteria
Inclusion
- All patients were required to give written informed consent.
- Patients with distant metastasis who primary received anthracycline and taxane adjuvant chemotherapy after surgery.
- After inorelbine and gemcitabine (NG) or vinorelbine and platinum (NP) regiments for 6 cycles,patients were assessed the effect of treatment. As for the patients with complete response (CR), partly response (PR) and stable disease(SD).
- Have normal cardiac functions by echocardiography
- ECOG scores are ≤ 0-1.
- Patients are disposed to practice contraception during the whole trial.
- The results of patients' blood tests are as follows:
- Hb ≥ 90 g/L WBC ≥ 3.0×109/L Plt ≥ 100×109/L Neutrophils ≥ 1.5×109/L ALT and AST ≤ 2.5 times of normal upper limit. TBIL ≤ 1.5 times of normal upper limit. Creatinine ≤ 1.5 times of normal upper limit.
Exclusion
- Have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
- Active infections.
- Severe non-cancerous diseases.
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 8 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03423849
Start Date
February 8 2018
End Date
February 8 2020
Last Update
February 6 2018
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