breast cancer
Conditions
Interventions
experimental group:palbociclib plus endocrine therapy
control group: endocrine therapy
Sponsors
Guangdong Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female, aged 18-60 years; 2. Histologically or cytologically confirmed breast cancer and has measurable or evaluable lesions; 3. The advanced first-line treatment regimen was endocrine therapy combined with palbociclib; 4. The therapeutic evaluation after advanced first-line treatment was heterogenous disease progression (as defined in the present study); 5. Blood routine examination was normal: A. White blood cell count (WBC) >= 3.0 * 10^9/L; B. Neutrophil count (ANC) >= 1.5 * 10^9 /L; C. Platelet count (PLT) >= 100 * 10^9/L; 6. Liver and kidney function tests were basically normal (the standard was the normal value of laboratory in each research center) : A. Total bilirubin (TBIL) = 60 ml/min; 7. Good physical status (0-2 in ECOG evaluation); 8. Life expectancy greater than 3 months;
Exclusion criteria
Exclusion criteria: 1. Previous history of non-breast malignancy; 2. Symptomatic visceral metastases (visceral crisis); 3. Associated with brain metastases; 4. Primary endocrine resistance (defined as recurrence and metastasis within 2 years of adjuvant endocrine therapy or disease progression within 6 months of advanced first-line endocrine therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical benefit rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;time to progress;duration of clinical benefit; | — |
Countries
China
Contacts
Public ContactQianjun Chen
Guangdong Hospital of Traditional Chinese Medicine
Outcome results
None listed