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New treatment option for HR+/HER2- Advanced Breast Cancer
Official title Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer
ClinicalTrials.gov ID: NCT05983107
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, being studied as a potential treatment for hr+/her2- advanced breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+/HER2- advanced breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- The age at the time of signing the informed consent form is ≥ 18 years old and ≤ 75 years old, for menopausal/premenopausal women (premenopausal...
- Breast cancer patients with HR positive (ER expression ≥ 10%, PR positive or negative) and HER2 negative (Immunohistochemical(IHC)0,1+; 2+...
- Histologically confirmed locally advanced breast cancer (no radical local treatment) or recurrent and metastatic breast cancer.
- The patients who had previously progressed after the treatment of first-line or second-line cyclin-dependent kinases 4 and 6 inhibitors（CDK4/6...
- At least one measurable primary lesion (according to RECIST v1.1 standard) before enrollment.
You likely can't join if
- Those who have received any mammalian target of rapamycin（mTOR） and histone deacetylase（HDAC） inhibitors at any time in the past.
- Received chemotherapy, Targeted therapy, immunotherapy, treatment therapy or other systematic anti-tumor treatment within 4 weeks before the first...
- people who have undergone major surgical procedures or obvious trauma within 4 weeks prior to enrollment, or are expected to undergo major surgical...
- people with brain or subdural metastasis are excluded. Unless its stability has been maintained for at least 4 weeks or Asymptomatic brain metastasis...
- According to the investigator's judgment, there are concomitant diseases (such as severe hypertension, Thyroid disease, hyperlipidemia, active...
- Patients with poor control of diabetes shall be determined by the researcher.
See the full eligibility criteria
- The age at the time of signing the informed consent form is ≥ 18 years old and ≤ 75 years old, for menopausal/premenopausal women (premenopausal women need to receive ovarian function suppression treatment at the same...
- Breast cancer patients with HR positive (ER expression ≥ 10%, PR positive or negative) and HER2 negative (Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH) not expanded) confirmed by histology.
- Histologically confirmed locally advanced breast cancer (no radical local treatment) or recurrent and metastatic breast cancer.
- The patients who had previously progressed after the treatment of first-line or second-line cyclin-dependent kinases 4 and 6 inhibitors（CDK4/6 inhibitors）of endocrine and whose chemotherapy was ≤ second-line (relapse...
- At least one measurable primary lesion (according to RECIST v1.1 standard) before enrollment.
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2.
- The toxic and side effects caused by previous anti-tumor therapy were relieved to 0-1 levels before the screening period (judged according to The NCI Common Terminology Criteria for Adverse Events version5.0...
- The functional level of organs must meet the following requirements: 1) Blood routine: Absolute neutrophil count(ANC)≥1.5 × 109/L (growth factor not used within 14 days); Platelet(PLT) ≥100 × 109/L (no corrective...
- Expected survival time ≥ 3 months.
- Voluntarily participate in this clinical trial and sign a written informed consent form.
- Those who have received any mammalian target of rapamycin（mTOR） and histone deacetylase（HDAC） inhibitors at any time in the past.
- Received chemotherapy, Targeted therapy, immunotherapy, treatment therapy or other systematic anti-tumor treatment within 4 weeks before the first administration of the study drug, or received radiotherapy within 3...
- people who have undergone major surgical procedures or obvious trauma within 4 weeks prior to enrollment, or are expected to undergo major surgical treatment.
- people with brain or subdural metastasis are excluded. Unless its stability has been maintained for at least 4 weeks or Asymptomatic brain metastasis can be included in the group.
- According to the investigator's judgment, there are concomitant diseases (such as severe hypertension, Thyroid disease, hyperlipidemia, active infection, etc.) that seriously endanger the patient's safety or affect the...
- Patients with poor control of diabetes shall be determined by the researcher.
- Clinically obvious gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, Bowel obstruction, etc.).
- Severe cardiovascular injury (greater than a history of congestive heart failure at New York Heart Association(NYHA) level II, unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia.
- people have active hepatitis (hepatitis B reference: HBsAg positive and hepatitis B virus(HBV) DNA ≥ 500 international unit(IU)/ml; hepatitis C reference: hepatitis C virus(HCV) antibody positive and HCV copy...
- Female patients during pregnancy and lactation, female patients with Fertility and positive baseline Pregnancy test, or those of childbearing age who are unwilling to take effective contraceptive measures during the...
- Have a clear history of neurological or mental disorders, including epilepsy or dementia, in the past.
- Any medical condition in which the researcher believes that the subject is not suitable for entry into the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.