Status:
UNKNOWN
Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Hormone Receptor Positive Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
A multi-center non-interventional observational study led by the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib based-therapy as initial endocrine ther...
Detailed Description
This study is designed to be a multi-center non-interventional observational study led by the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients wit...
Eligibility Criteria
Inclusion
- 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
- ≥ 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).
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05343117
Start Date
December 1 2021
End Date
June 1 2024
Last Update
April 26 2022
Active Locations (9)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
3
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China, 100038
4
The Third Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100039