Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype

NCT05954442 | Recruiting Phase 3

• 1 other identifier: SCHBCC-N058
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Cancer; Metastatic Breast Cancer; Mutation

Keywords

triple negative breast cancer; metastatic breast cancer; PI3K/AKT/mTOR mutation

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.

  Approximately 3 years

Secondary Outcomes (6)

• Objective response rate (ORR)

  Approximately 3 years

• Duration of response (DoR)

  Approximately 3 years

• Disease control rate (DCR)

  Approximately 3 years

• Overall survival (OS)

  Approximately 3 years

• Safety and tolerability

  Approximately 3 years

Study Arms (2)

Arm A

EXPERIMENTAL

Everolimus plus Investigator's Choice of Chemotherapy

Drug: Everolimus; Drug: Investigator's Choice of Chemotherapy

Arm B

ACTIVE COMPARATOR

Investigator's Choice of Chemotherapy

Drug: Investigator's Choice of Chemotherapy

Interventions

Everolimus DRUG

Everolimus is a kind of mTOR inhibitors which has been approved to use in several kinds of cancers, especially in metastatic breast cancer .

Also known as: Afinitor

Arm A

Investigator's Choice of Chemotherapy DRUG

Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic triple negative breast cancer, including nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone.

Also known as: ICC

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 1.1;
• 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, endogenous creatinine clearance \> 50ml/min (Cockcroft-Gault formula);
• 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 present, the wound has fully healed); No peripheral neuropathy or grade I peripheral neurotoxicity;
• 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.

You may not qualify 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 clinically suspected central nervous system metastasis, enhanced CT or enhanced MRI must be performed within 28 days before the first dose to rule out central nervous system metastasis.
• 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 investigator's notes;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Zhimin Shao, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 20, 2023
• Study Start: September 13, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CN (1)