Comparative Effectiveness of PAL Based-therapy as Initial... | NCT05343117

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Palbociclib based-therapy as initial endocrine therapy		Adult patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy as initial endocrine therapy from August 1, 2018 to December 31, 2023.	Drug: Palbociclib based-therapy as initial endocrine therapy
Palbociclib based-therapy after chemotherapy		Adult patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy after chemotherapy from August 1, 2018 to December 31, 2023.	Drug: Palbociclib based-therapy after chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Palbociclib based-therapy as initial endocrine therapy	Drug	Palbociclib + aromatase inhibitor/fulvestrant (initial endocrine therapy)	Palbociclib based-therapy as initial endocrine therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	It is defined as the time (months) from the start of palbociclib based-therapy to progressive disease or all-cause mortality. The progressive disease is determined by clinicians based on the results of clinical evaluation, laboratory tests, imaging or pathological examinations. Patients who have not died or have not experienced progressive disease will be censored at the beginning of next-line treatment or at the last visit during the study period.	From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) reported by doctors among all patients with response data available.	From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years, female (retrospective part);
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);
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);
The follow-up time was not less than 3 months after the initiation of palbociclib in combination with endocrine therapy (retrospective part);
Age ≥ 18 years, female (prospective part);
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);
ECOG PS ≤ 2, and expected survival of more than half a year and no life-threatening visceral metastasis (prospective part);
Measurable disease (prospective part);
No or up to 1 regimen of chemotherapy for advanced breast cancer (prospective part);
The patient has good compliance, and needs to receive the treatment with the palbociclib-based therapy according to the condition (prospective part);
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);
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:

≥ 2 prior lines of chemotherapy for advanced breast cancer (retrospective part);
Treatment with other CDK4/6 inhibitors (abemaciclib or ribociclib) or endocrine therapy only (retrospective part);
Life-threatening visceral metastases, and lesions not evaluable for response (prospective part);
Neutrophils < 1.5 × 10^9/L; platelets < 100 × 10^9/L; not improved after medication (prospective part);
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);
Have central nervous system or meningeal invasion (prospective part);
Women who are pregnant, lactating, or planning to have children (prospective part);
Received ≥ 2 prior lines of chemotherapy for advanced breast cancer (prospective part);
Treatment with other CDK4/6 inhibitors (abemaciclib or ribociclib) or endocrine therapy only (prospective part);
Concomitant poorly controlled serious illness, major surgery, or history of other malignancy within 5 years (prospective part);
Other conditions that the investigator considers inappropriate for inclusion (prospective part).