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New treatment option for Triple Negative Breast Cancer
Official title Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype
ClinicalTrials.gov ID: NCT05954442
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, being studied as a potential treatment for triple negative breast cancer.
Also referred to as Afinitor.
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
- The goal of this clinical trial is to evaluate the efficacy of investigator's choice of chemotherapy, either alone or in combination with everolimus, in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer, luminal androgen receptor (LAR) subtype with PI3K/AKT/mTOR (PAM) pathway mutation, as the first-line treatment.
- Phase 3: a large, late-stage study
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 70, women only
You may be able to join if
- Patients need to meet all of the following conditions
- Patients must be ≥18 and ≤ 70 years of age;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- The expected survival is more than 3 months;
- Pathologically confirmed breast cancer is triple negative breast cancer (IHC ER \< 1%, PR\<1%, HER2 0 OR +, if HER2++, FISH negative), and LAR...
You likely can't join if
- Patients with any of the following conditions were excluded from the study:
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with...
- A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within...
- Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be...
- Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular...
- Pregnant or lactating patients;
See the full eligibility criteria
- Patients need to meet all of the following conditions
- Patients must be ≥18 and ≤ 70 years of age;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- The expected survival is more than 3 months;
- Pathologically confirmed breast cancer is triple negative breast cancer (IHC ER \< 1%, PR\<1%, HER2 0 OR +, if HER2++, FISH negative), and LAR subtype with mutation in PAM pathway;
- Recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible;.
- No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;
- Patients with at least one lesion (measurable and/or unmeasurable) that has not previously received radiation therapy can be accurately evaluated by CT/MRI at baseline and can be evaluated repeatedly according to RECIST...
- The functions of the main organs are basically normal, and the following conditions are met:
- Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
- Biochemical examination shall meet the following standards: TBIL≤1.5× upper limit of normal value(ULN); alanine aminotransferase (ALT) and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1×ULN...
- Patients have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks prior to study initiation, and have recovered from acute toxic effects of prior treatment (if surgery is...
- Fertile female are required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
- Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.
- Patients with any of the following conditions were excluded from the study:
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced...
- A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the...
- Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access);
- Pregnant or lactating patients;
- Other malignancies within the previous 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma;
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
- There is a third space effusion that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites);
- Participated in other anti-tumor drug clinical trials within 4 weeks before taking the study drug for the first time;
- Long-term unhealed wounds or incomplete healing fractures;
- Patients with known Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection active phase or hepatitis B DNA≥500, or chronic phase with abnormal liver function;
- Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
- The investigator does not consider the patient suitable for participation in any other circumstances of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai 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.