Breast CancerNCT04289974
Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer
An observational study of Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a multi-center, observational study designed to explore the regulatory mechanism of palbociclib correlative pathways in therapeutic process of breast cancer, employing next generation sequencing (NGS) on DNA and RNA. This study also monitor the clonal evolution of genes by tracing the ctDNA. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Palbociclib
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2019to Apr 2022
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: metastatic breast cancer patients of ER+/HER2- with resistance of first line endocrine therapy
Who may be able to join
- women aged 18-70 years old at the time of sign informed consent
- patients diagnosed as breast cancer with evidence supporting metastatic disease, unsuitable for radical operation or radiotherapy, with no chemotherapy indication
- full histological or cytological assessment of ER+, HER2- breast cancer
- refractory to the most recent endocrine therapy, or progression within 12 months of endocrine therapy
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1, no refractory within recent 2 weeks
- patients with at least 1 measuralbe lesion; lesions will be excluded if received radiotherapy, unless had confirmed progression
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- life expectancy of 12 weeks or more
- clinical laboratory test indicators meet the following criteria:
- PLT≥100×10^9/L
- ANC≥1.5×10^9/L
- Hgb≥90 g/L
- TBil≤1.5 ULN
- ALT and AST ≤3 ULN
- creatinine≤1.5 ULN or creatinine clearance rate≥50 mL/min
- patients who signed informed consents before any projects, sampling and analysis; be available of tumor tissue biopsy and liquid biopsy; be cooperative for observation period
- patients can swallow oral drugs
- In addition to alopecia and stable peripheral neurotoxicity below grade 2, any clinical toxicity associated with previous treatment prior to enrollment must be restored to baseline or grade 1.
Who cannot join
- no prior treatment
- receiving treatment other than the trial 4 weeks prior to the study, or participating in another clinical study
- unwilling to provide tissue and blood for genetic testing
- non-resistant on endocrine therapy before treating with palbociclib
- progress of ≥ 2nd line endocrine therapy
- patients with advanced disease, symptoms, visceral spread, and life-threatening complications in the short term (including large uncontrollable spills [thoracic, pericardium, abdominal cavity], pulmonary lymphangitis, and liver involvement>50%)
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- patients with active, uncontrolled or symptomatic central nervous system metastases, cancerous meningitis or clinical signs suggesting pia mater disease, brain edema and/or tumor growth. Patients with a history of central nervous system metastasis or spinal cord compression, if they have received local treatment (such as radiation therapy, stereotactic surgery) and are clinically stable, they need to stop convulsions and steroids for at least 4 weeks before randomization.
- patients received major surgery, chemotherapy, radiation therapy, or other anticancer treatments within 2 weeks prior to enrollment
- diagnosis of any other malignant tumor, within 3 years prior to the enrollment, except adequately treated basal/squamous cell skin cancer or cervical carcinoma
- assessed as not eligible to participate in the trial
- infused whole blood without leukocytes removing within 120 days prior to sampling
- during lactation or with positive blood or urine pregnancy test
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, ChineseAMS
Beijing, Beijing Municipality, 100021
Qiao LI, MD, 86-10-87788120, liqiaopumc@yahoo.cn
Binghe XU, MD, PHD, 86-10-87788495, xubinghe@medmail.com.cn
About this study
Official title: An Open, Multicenter Study for the Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer
This is a multi-center, observational study designed to explore the regulatory mechanism of palbociclib correlative pathways in therapeutic process of breast cancer, employing next generation sequencing (NGS) on DNA and RNA. This study also monitor the clonal evolution of genes by tracing the ctDNA.
- Conditions
- Breast Cancer
- Being tested
- Palbociclib
- Keywords
- Palbociclib, endocrinotherapy, resistance
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Fulvestrant
Palbociclib (125 mg PO qDay for Days 1-21 of each 28-day cycle) combined with Fulvestrant (500 mg IM on Days 1, 15, and 29, and then once monthly thereafter)
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib+fulvestrant | 100 cases of patients with ER+, HER2- breast cancer, experienced resistance after first line endocrinotherapy, will be assigned participants into treatment regimen, including palbociclib combined with fulvestrant.
FFPE blocks/sections or fresh tumor tissues/biopsies will be obtained from the hospitals on the points before administration and since resistance appearance. The tissue will be sequenced by a pan-cancer DNA panel (500+ genes) and whole transcriptome sequencing (WTS).
5-10 ml peripheral blood will be collected from each patient on the points before administration, 1 month after treatment, every subsequent visit and resistance appearance. The liquid biopsy will be sequenced by a pan-cancer ctDNA panel (300+ genes).
The genomic characteristics of patients received resistance will be analyzed. The relevant pathway mechanisms will be identified. Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathway regulatory mechanism during palbociclib treatment on ER+/HER2- breast cancer.
Crosstalk patterns of genetic change processes with significant correlation with treatment of palbociclib combined endocrinotherapy, assessed by DNA and RNA sequencing.
Measured: 2 year
Patterns of clonal changing on lesions during treatment of palbociclib combined endocrinotherapy.
The evolution patterns of genetic profiles since the begining of palbociclib combined endocrinotherapy until occurance of drug resistance obtained by collecting ctDNA variations dynamically.
Measured: 2 year
Secondary outcomes (2)
Genetic indicators of effect and prognosis of palbociclib combined endocrinotherapy on ER+/HER2- breast cancer.
Indicator genes with measurable up/down regulated activities of ER+/HER2- breast cancer patients significantly correlated with treatment of palbociclib combined endocrinotherapy.
Measured: 2 year
Genetic indicators of resistance of palbociclib combined endocrinotherapy on ER+/HER2- breast cancer.
Specific genetic aberrations in alternative pathways, i.e. CCND1 amplification or RB1 inactivation, before treatment of palbociclib combining with endocrinotherapy and after drug-resistance of the breast cancer patients.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start14 Feb 2019
- Primary completionJun 2020 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- OrigiMed
- Responsible party
- Principal investigator, Li Qiao, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, PHD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289974
- Sponsor's protocol ID
- LQ005
- Status last verified
- Feb 2020
- First submitted
- 31 Jul 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Study for the Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer
- ClinicalTrials.gov ID
- NCT04289974
- Acronym / sponsor ID
- LQ005
- Conditions
- Breast Cancer
- Keywords
- Palbociclib, endocrinotherapy, resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- OrigiMed
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 28 Feb 2020 (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.
This is a multi-center, observational study designed to explore the regulatory mechanism of palbociclib correlative pathways in therapeutic process of breast cancer, employing next generation sequencing (NGS) on DNA and RNA. This study also monitor the clonal evolution of genes by tracing the ctDNA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib+fulvestrant | – | Drug: Palbociclib100 cases of patients with ER+, HER2- breast cancer, experienced resistance after first line endocrinotherapy, will be assigned participants into treatment regimen, including palbociclib combined with fulvestrant. FFPE blocks/sections or fresh tumor tissues/biopsies will be obtained from the hospitals on the points before administration and since resistance appearance. The tissue will be sequenced by a pan-cancer DNA panel (500+ genes) and whole transcriptome sequencing (WTS). 5-10 ml peripheral blood will be collected from each patient on the points before administration, 1 month after treatment, every subsequent visit and resistance appearance. The liquid biopsy will be sequenced by a pan-cancer ctDNA panel (300+ genes). The genomic characteristics of patients received resistance will be analyzed. The relevant pathway mechanisms will be identified. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic breast cancer patients of ER+/HER2- with resistance of first line endocrine therapy
Key inclusion criteria (17 listed)
- women aged 18-70 years old at the time of sign informed consent
- patients diagnosed as breast cancer with evidence supporting metastatic disease, unsuitable for radical operation or radiotherapy, with no chemotherapy indication
- full histological or cytological assessment of ER+, HER2- breast cancer
- refractory to the most recent endocrine therapy, or progression within 12 months of endocrine therapy
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1, no refractory within recent 2 weeks
Key exclusion criteria (12 listed)
- no prior treatment
- receiving treatment other than the trial 4 weeks prior to the study, or participating in another clinical study
- unwilling to provide tissue and blood for genetic testing
- non-resistant on endocrine therapy before treating with palbociclib
- progress of ≥ 2nd line endocrine therapy
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 |
|---|---|---|
| PalbociclibAlso: FulvestrantPalbociclib (125 mg PO qDay for Days 1-21 of each 28-day cycle) combined with Fulvestrant (500 mg IM on Days 1, 15, and 29, and then once monthly thereafter) | Drug | Palbociclib+fulvestrant |
Primary outcome
Pathway regulatory mechanism during palbociclib treatment on ER+/HER2- breast cancer.
Time frame: 2 year
Crosstalk patterns of genetic change processes with significant correlation with treatment of palbociclib combined endocrinotherapy, assessed by DNA and RNA sequencing.
Patterns of clonal changing on lesions during treatment of palbociclib combined endocrinotherapy.
Time frame: 2 year
The evolution patterns of genetic profiles since the begining of palbociclib combined endocrinotherapy until occurance of drug resistance obtained by collecting ctDNA variations dynamically.
2 secondary outcomes
Genetic indicators of effect and prognosis of palbociclib combined endocrinotherapy on ER+/HER2- breast cancer.
Time frame: 2 year
Genetic indicators of resistance of palbociclib combined endocrinotherapy on ER+/HER2- breast cancer.
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Binghe Xu, PHD principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site 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 17 inclusion and 12 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Qiao Li, MD (86-10-87788120, liqiaopumc@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathway regulatory mechanism during palbociclib treatment on ER+/HER2- breast cancer. (time frame: 2 year). The study lists 2 primary outcomes in all. 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 28 Feb 2020.