Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC

NCT05343117 | Unknown

• 1 other identifier: NCC3222
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 9

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 therapy versus palbociclib based-therapy after chemotherapy for HR+/HER2- advanced breast cancer.

Conditions

Hormone Receptor Positive Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Objective response rate (ORR)

  From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.

• Disease control rate (DCR)

  From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.

Study Arms (2)

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

Palbociclib based-therapy as initial endocrine therapy DRUG

Palbociclib + aromatase inhibitor/fulvestrant (initial endocrine therapy)

Palbociclib based-therapy as initial endocrine therapy

Palbociclib based-therapy after chemotherapy DRUG

Palbociclib + aromatase inhibitor/fulvestrant (after chemotherapy)

Palbociclib based-therapy after chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy as initial endocrine therapy versus palbociclib based-therapy after chemotherapy from August 1, 2018 to December 31, 2023.

You may qualify if:

• 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).

You may not qualify if:

• ≥ 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);

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (9)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

The Third Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100043, China

RECRUITING

The Fourth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

PLA Strategic Support Force Characteristic Medical Center

Beijing, Beijing Municipality, 100101, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Study Officials

• Peng Yuan, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, M.D.

CONTACT

+8613501270834; yuanpeng01@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

CN (9)