CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 203 target
Drug / intervention
Everolimus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05954442
NCT05954442Phase 3RecruitingUpdate OverdueUpdated 29mo ago · Completion was 10mo ago
Enrollment Stalled
Update Overdue

An Open, Randomized Phase III Study of Everolimus With Investigator's Choice of Chemotherapy Versus Chemotherapy in The First-Line Treatment of Luminal Androgen Receptor (LAR) Subtype With PI3K/AKT/mTOR Pathway Mutation of Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer (BCTOP-T-M03)

Fudan University·interventional·Posted Jul 20, 2023·Updated Jan 16, 2024

In Brief

A Phase 3 clinical trial evaluating Everolimus and Investigator's Choice of Chemotherapy for Triple Negative Breast Cancer and 2 related conditions. Currently recruiting, targeting 203 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
202420252026
First PostedJul 20, 2023
Enrollment StartSep 13, 2023
Primary CompletionAug 1, 2025
Study CompletionAug 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.9 yearsPosted 2.9 years ago

Interventions

Everolimusdrug

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

Investigator's Choice of Chemotherapydrug

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.