| Eligibility |
Inclusion Criteria:
1. Age = 18 years, female (retrospective part);
2. Histologically or cytologically confirmed recurrent or metastatic HR+/HER2- breast
cancer, if there was metastatic pathology, the histological pathology of metastases
should prevail (retrospective part);
3. Received palbociclib in combination with endocrine therapy as initial therapy in the
first line and received at least 1 cycle; or received systemic chemotherapy in the
first line followed by sequential palbociclib in combination with endocrine therapy
and received at least 1 cycle (retrospective part);
4. The follow-up time was not less than 3 months after the initiation of palbociclib in
combination with endocrine therapy (retrospective part);
5. Age = 18 years, female (prospective part);
6. Histologically or cytologically confirmed recurrent or metastatic HR+/HER2- breast
cancer, if there is metastatic pathology, the histological pathology of metastases
should prevail (prospective part);
7. ECOG PS = 2, and expected survival of more than half a year and no life-threatening
visceral metastasis (prospective part);
8. Measurable disease (prospective part);
9. No or up to 1 regimen of chemotherapy for advanced breast cancer (prospective part);
10. The patient has good compliance, and needs to receive the treatment with the
palbociclib-based therapy according to the condition (prospective part);
11. Normal function of major organs and hematopoietic function, i.e. meeting the following
criteria: Blood cell count criteria should be in accordance with: (no blood
transfusion and blood products, no G-CSF and other hematopoietic stimulating factors
for correction in recent 14 days): Hemoglobin (HB) = 80 g/L; Neutrophils (ANC) = 1.5 ×
10^9/L; Platelet (PLT) = 75 × 10^9/L. Liver function, renal function and electrolytes
meeting the following criteria: Total bilirubin (TBIL) < 1.5 upper limit of normal
(ULN), = 3 ULN for patients with liver metastases; Alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) = 3 ULN, and = 5 ULN for patients with liver
metastases; Serum Cr = 1.5 ULN or endogenous creatinine clearance = 60 ml/min
(Cockcroft-Gault formula); Electrolytes: magnesium = lower limit of normal (LLN)
(prospective part);
12. The patient is compliant and voluntarily accepts the treatment, follow-up visit,
laboratory examination and other study procedures according to the doctor's
prescription (prospective part).
Exclusion Criteria:
1. = 2 prior lines of chemotherapy for advanced breast cancer (retrospective part);
2. Treatment with other CDK4/6 inhibitors (abemaciclib or ribociclib) or endocrine
therapy only (retrospective part);
3. Life-threatening visceral metastases, and lesions not evaluable for response
(prospective part);
4. Neutrophils < 1.5 × 10^9/L; platelets < 100 × 10^9/L; not improved after medication
(prospective part);
5. Total bilirubin = 1.5 times the upper limit of normal, AST and ALT = 2 times the upper
limit of normal; serum Cr = 1.5 times the upper limit of normal (prospective part);
6. Have central nervous system or meningeal invasion (prospective part);
7. Women who are pregnant, lactating, or planning to have children (prospective part);
8. Received = 2 prior lines of chemotherapy for advanced breast cancer (prospective
part);
9. Treatment with other CDK4/6 inhibitors (abemaciclib or ribociclib) or endocrine
therapy only (prospective part);
10. Concomitant poorly controlled serious illness, major surgery, or history of other
malignancy within 5 years (prospective part);
11. Other conditions that the investigator considers inappropriate for inclusion
(prospective part).
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