Adjuvant Intensification for LAR
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
This study enrolled patients with early-stage triple-negative breast cancer who had undergone radical surgery. The postoperative pathology met the TNM staging criteria of pT1c-3N0-3M0, and immunohistochemistry (IHC) results confirmed ER-negative status (IHC showed \<1% of tumor cells positive for ER), PR-negative status (IHC showed \<1% of tumor cells positive for PR), and HER2-negative status (IHC intensity of 0 or 1+; or IHC intensity of 2+ but with negative in situ hybridization results). Additionally, patients either exhibited high AR expression (IHC showing AR ≥10%) or were classified as the LAR subtype based on digital pathology.
This study plans to prospectively enroll 904 subjects, who will be randomized in a 1:1 ratio after completing standard chemotherapy. They will be allocated to either the standard-of-care (SOC) chemotherapy followed by everolimus group or the SOC-alone group. The study aims to evaluate the efficacy of SOC chemotherapy followed by everolimus versus SOC chemotherapy alone as adjuvant therapy for patients with early-stage radically resected triple-negative breast cancer of the LAR subtype, with the primary endpoint being 3-year invasive disease-free survival (iDFS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, aged ≥18 years and ≤70 years.
ECOG performance status 0-1.
Histologically confirmed invasive triple-negative breast cancer (**definition**: breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all confirmed negative by pathology. Specifically: **ER-negative**: IHC <1%; **PR-negative**: IHC <1%; **HER2-negative**: IHC 0/1+ or IHC 2+ but FISH/CISH negative. Additionally, histology must confirm **high AR expression**: AR IHC ≥10%, **or** digital pathology indicates the LAR subtype.
Underwent radical surgery for early-stage breast cancer, with postoperative pathology meeting TNM staging **pT1c-3N0-3M0**.
Disqualifiers
Bilateral breast cancer.
Metastatic disease at any site.
Patients with cT > 2 cm or positive lymph nodes **and** carrying pathogenic/likely pathogenic germline BRCA1/2 mutations.
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.
Trial design
Design model
Parallel
Treatments tested in this trial
Everolimus 10 mg daily
DrugAfter completion of standard chemotherapy, everolimus at a fixed dose of 10 mg orally once daily continuously for a duration of 1 year.
Treatment groups
904 Participants
are divided into 2 treatment groupsGroup A: SOC-everolimusExperimental treatment 1 intervention
Group B: SOCNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
iDFS
It is defined as the percentage of patients who remain free of invasive disease recurrence, secondary primary invasive cancers, or death from any cause over a 3-year period from randomization or initiation of study treatment.
Time frame
3 yearSecondary outcomes
1
DFS
It measures the proportion of patients who remain free of detectable disease (including recurrence, progression, or new primary cancer) and alive for 3 years after starting treatment or randomization.
Time frame
3 year2
DDFS
3-year DDFS is an oncology clinical trial endpoint that specifically measures the proportion of patients who remain free of distant metastasis (spread of cancer to remote organs) and death from the cancer within 3 years after initiation of study treatment or randomization. It focuses exclusively on distant metastatic events rather than all disease recurrences.
Time frame
3year3
RFS
3-year RFS is an oncology clinical trial endpoint that measures the proportion of patients who remain free of disease recurrence (local, regional, or distant) for 3 years following curative-intent treatment (typically surgery). It specifically focuses on recurrence of the original primary cancer and does not include new primary cancers unrelated to the initial diagnosis.
Time frame
3 year4
OS
Overall Survival (OS) is the gold standard efficacy endpoint in oncology clinical trials, defined as the time from randomization (or treatment initiation) to death from any cause. It represents the most objective and clinically meaningful measure of treatment benefit, directly reflecting whether a therapy prolongs patients' lives.
Time frame
3 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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