Breast Cancer FemalesPhase 3POLARISNCT07407517
Adjuvant Intensification for LAR
A Phase 3 study testing Everolimus 10 mg daily in people with Breast Cancer Females and Triple Negative Breast Cancer (TNBC), run by Fudan University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Females, Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Everolimus 10 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 904 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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.
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- 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.
- Biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; serum Cr ≤ 1 × ULN, with creatinine clearance >50 mL/min (Cockcroft-Gault formula).
- 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.
Who cannot join
- Patients who meet any of the following criteria will be excluded from this study:
- 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.
- History of clinically significant pulmonary disease, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonitis (except for asymptomatic radiation changes not requiring intervention); or suspected such disease based on screening examinations.
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- History of other malignancies within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- Pregnant or lactating women; women of childbearing potential who cannot practice effective contraception.
- Patients concurrently participating in other clinical trials.
- Patients with a history of hypersensitivity or known allergy to any component of the study drugs; or patients with a history of allergy to other monoclonal antibodies.
- Severe or uncontrolled infection.
- Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
- History of gastrointestinal bleeding within the past 6 months, or clear tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, locally active ulcerative lesions, or fecal occult blood ≥ (++). Patients with fecal occult blood (+) must undergo gastroscopy for further evaluation.
- Known active HBV or HCV infection (HBV-DNA ≥ 500 IU/mL), or chronic infection with abnormal liver function.
- Urinalysis showing urine protein ≥ ++, or 24-hour urine protein quantification > 1.0 g.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment.
- History of drug abuse (psychoactive substances) with inability to abstain, or history of psychiatric disorders.
- Patients deemed unsuitable for participation by the investigator's judgment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Standard Chemotherapy Plus Oral Everolimus as Adjuvant Therapy for LAR Breast Cancer Patients: A Randomized, Open-Label, Phase III Trial （POLARIS）
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).
- Being tested
- Everolimus 10 mg daily
- Keywords
- breast cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus 10 mg dailyDrug
After completion of standard chemotherapy, everolimus at a fixed dose of 10 mg orally once daily continuously for a duration of 1 year.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Everolimus 10 mg daily |
| SOC | No intervention | After completion of standard chemotherapy, undergo observation and follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 year
Secondary outcomes (6)
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.
Measured: 3 year
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.
Measured: 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.
Measured: 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.
Measured: 3 year
Safety and Tolerability
Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 5.0) Toxicity Reporting Criteria.
Measured: 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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2033 (estimated)
- Study completion1 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 904 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407517
- Sponsor's protocol ID
- SCHBCC-N0108
- Acronym
- POLARIS
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Chemotherapy Plus Oral Everolimus as Adjuvant Therapy for LAR Breast Cancer Patients: A Randomized, Open-Label, Phase III Trial （POLARIS）
- ClinicalTrials.gov ID
- NCT07407517
- Acronym / sponsor ID
- POLARIS / SCHBCC-N0108
- Keywords
- breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 904 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2033 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC-everolimus | Experimental | Drug: Everolimus 10 mg dailyAfter completion of standard chemotherapy, everolimus at a fixed dose of 10 mg orally once daily continuously for a duration of 1 year. |
| SOC | No intervention | –After completion of standard chemotherapy, undergo observation and follow-up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- 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.
Key exclusion criteria (18 listed)
- Patients who meet any of the following criteria will be excluded from this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus 10 mg dailyAfter completion of standard chemotherapy, everolimus at a fixed dose of 10 mg orally once daily continuously for a duration of 1 year. | Drug | SOC-everolimus |
Primary outcome
iDFS
Time frame: 3 year
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.
6 secondary outcomes
DFS
Time frame: 3 year
DDFS
Time frame: 3year
RFS
Time frame: 3 year
OS
Time frame: 3 year
Safety and Tolerability
Time frame: 3 year
Quality of Life score in the per-protocol population
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus 10 mg daily in people with Breast Cancer Females and Triple Negative Breast Cancer (TNBC), run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao Professor (08664175590 ext. Ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.