Hormone Receptor Positive Advanced Breast CancerNCT05343117
Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC
An observational study of Hormone Receptor Positive Advanced Breast Cancer, run by Chinese Academy of Medical Sciences at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor Positive Advanced Breast Cancer
- What is being tested?
- Palbociclib based-therapy as initial endocrine therapy and Palbociclib based-therapy after chemotherapy
- How many people
- 400 participants
- Where
- 9 sitesChina
- Study dates
- 1 Dec 2021to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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);
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- 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).
Who cannot join
- ≥ 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);
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- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
- Recruiting
The Third Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039
- Recruiting
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100043
- Recruiting
The Fourth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100048
- Recruiting
PLA Strategic Support Force Characteristic Medical Center
Beijing, Beijing Municipality, 100101
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
About this study
Official title: 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.
Read the 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.
- Being tested
- Palbociclib based-therapy as initial endocrine therapy, Palbociclib based-therapy after chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib based-therapy as initial endocrine therapyDrug
Palbociclib + aromatase inhibitor/fulvestrant (initial endocrine therapy)
Palbociclib based-therapy after chemotherapyDrug
Palbociclib + aromatase inhibitor/fulvestrant (after chemotherapy)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Palbociclib based-therapy after chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343117
- Sponsor's protocol ID
- NCC3222
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05343117
- Acronym / sponsor ID
- NCC3222
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palbociclib based-therapy as initial endocrine therapy | – | Drug: Palbociclib based-therapy as initial endocrine therapyAdult patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy as initial endocrine therapy from August 1, 2018 to December 31, 2023. |
| Palbociclib based-therapy after chemotherapy | – | Drug: Palbociclib based-therapy after chemotherapyAdult patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy after chemotherapy from August 1, 2018 to December 31, 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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);
Key exclusion criteria (11 listed)
- ≥ 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palbociclib based-therapy as initial endocrine therapyPalbociclib + aromatase inhibitor/fulvestrant (initial endocrine therapy) | Drug | Palbociclib based-therapy as initial endocrine therapy |
| Palbociclib based-therapy after chemotherapyPalbociclib + aromatase inhibitor/fulvestrant (after chemotherapy) | Drug | Palbociclib based-therapy after chemotherapy |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Yuan, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone Receptor Positive Advanced Breast Cancer, run by Chinese Academy of Medical Sciences at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Yuan, M.D. (+8613501270834, yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.