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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC-everolimus | Experimental | After completion of standard chemotherapy, everolimus at a fixed dose of 10 mg orally once daily continuously for a duration of 1 year. |
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| SOC | No Intervention | After completion of standard chemotherapy, undergo observation and follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus 10 mg daily | Drug | After completion of standard chemotherapy, everolimus at a fixed dose of 10 mg orally once daily continuously for a duration of 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 year |
| DDFS |
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Inclusion Criteria:
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Patients must meet **all** of the following inclusion criteria to be enrolled in this study:
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**.
Patients with early-stage breast cancer who have received **at least 4 cycles of neoadjuvant chemotherapy containing anthracycline or taxane agents**, **did not achieve pathological complete response (pCR)**, and **do not carry pathogenic/likely pathogenic germline BRCA1/2 mutations**.
Adequate organ function, meeting the following criteria:
**Hematology**: HB ≥ 90 g/L (no transfusion within 14 days); ANC ≥ 1.5 × 10⁹/L; PLT ≥ 75 × 10⁹/L.
Surgical wound fully healed before study initiation.
Females of childbearing potential must use a medically approved contraceptive method during the study treatment and for at least 3 months after the last dose of study drug.
The patient voluntarily agrees to participate, signs the informed consent form, demonstrates good compliance, and agrees to follow-up.
Exclusion Criteria:
Patients who meet **any** of the following criteria will be excluded from this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao Professor | Contact | 08664175590 | Ext. 88807 | zhimingshao@yahoo.com |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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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.
| 3year |
| 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. | 3 year |
| 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. | 3 year |
| Safety and Tolerability | Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 5.0) Toxicity Reporting Criteria. | 3 year |
| Quality of Life score in the per-protocol population | The quality of life of patients was assessed using the EORTC QLQ-C30 questionnaire before, during, and after treatment. | 3 year |
| D017437 |
| Skin and Connective Tissue Diseases |