Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Chinese Academy of Medical Sciences
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Updated on 16 February 2024
See if I qualify
cancer
breast cancer
metastasis
hormone therapy
endocrine therapy
palbociclib
liquid biopsy
her2-negative breast cancer
her2/neu-negative breast cancer
hair thinning
HER2

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.

Details
Condition Breast Cancer, Breast Cancer
Age 18years - 70years
Treatment Palbociclib
Clinical Study IdentifierNCT04289974
SponsorChinese Academy of Medical Sciences
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
life expectancy of 12 weeks or more
clinical laboratory test indicators meet the following criteria
PLT10010^9/L
ANC1.510^9/L
Hgb90 g/L
TBil1.5 ULN
ALT and AST 3 ULN
creatinine1.5 ULN or creatinine clearance rate50 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

Exclusion Criteria

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%)
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
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cancer
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hormone therapy
endocrine therapy
palbociclib
liquid biopsy
her2-negative breast cancer
her2/neu-negative breast cancer
hair thinning
HER2

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