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

April 24, 2022 updated by: PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Comparative Effectiveness of Palbociclib Based-therapy as Initial Endocrine Therapy Versus Palbociclib Based-therapy After Chemotherapy for HR+/HER2- Advanced Breast Cancer in Chinese Clinical Practice: a Real-world Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 with HR+/HER2- advanced breast cancer who received palbociclib based-therapy as initial endocrine therapy or palbociclib based-therapy after chemotherapy from August 1, 2018 to December 31, 2023. It is expected to enroll 400 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected in a mixed manner, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China, 100038
        • Recruiting
        • Beijing Shijitan Hospital
      • Beijing, Beijing, China, 100039
        • Recruiting
        • The Third Medical Center of PLA General Hospital
      • Beijing, Beijing, China, 100043
        • Recruiting
        • Beijing Chao-Yang Hospital
      • Beijing, Beijing, China, 100048
        • Recruiting
        • The Fourth Medical Center of PLA General Hospital
      • Beijing, Beijing, China, 100101
        • Recruiting
        • PLA Strategic Support Force Characteristic Medical Center
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • The Fourth Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 + aromatase inhibitor/fulvestrant (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
Palbociclib + aromatase inhibitor/fulvestrant (after chemotherapy)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
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.
Disease control rate (DCR)
Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
DCR is defined as the proportion of patients who have reached CR, PR, or stable disease (SD) reported by the 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCC3222

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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