The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
Breast Cancer, Chemotherapy Effect, Disease-free Survival
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
The original program (NG/NP)
One of the original program (N)
Capecitabine monotherapy
Vinorelbine injection 25mg/m2 on day 1 and day 8, Gemcitabine injection 1250mg/m2 on day1 and day 8,every 3 weeks for 3 cycles(for the patients who used the NG salvage therapy) or Vinorelbine injection 25mg/m2 on day 1 and day 8,Cisplatin injection 25mg/m2 on day1,every 3 weeks for 3 cycles(for the patients who used the NP salvage therapy )
Vinorelbine injection,25mg/m2 on day 1 and day 8,every 3 weeks for 6 cycles. or, Vinorelbine oral 60mg/m2 on day 1,every week for 6 cycles.
Capecitabine oral 1250mg/m2,bid,for 6 cycles