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Breast CancerPhase 2NCT07305246

Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer

A Phase 2 study testing SHR-A1811, Letrozole and TAC/AC-T in people with Breast Cancer, run by First Hospital of China Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This is a prospective, randomized, multi-cohort, Phase II clinical trial. The study plans to enroll 120 patients with early-stage or locally advanced, HR-positive, HER2-low breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
SHR-A1811, Letrozole and TAC/AC-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Dec 2025to Sep 2027
Phase
Phase 2
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

  • Female, aged ≥18 years and ≤70 years;
  • Histopathologically confirmed invasive breast cancer with no prior systemic anticancer therapy for breast cancer;
  • Histopathologically confirmed HR-positive (ER ≥1% and/or PR ≥1%) with HER2-low expression (defined as IHC 1+/2+ and FISH negative);
  • Stage II-III breast cancer (cT2-cT4 or N+, cM0) according to the 8th edition AJCC Breast Cancer Staging Manual;
  • At least one measurable target lesion per RECIST V1.1;
  • ECOG performance status score of 0 to 1;
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  • Organ function levels must meet the following requirements (no corrective therapy with blood components or growth factors within 14 days prior to first dose):
  • Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelets ≥100×10^9/L, hemoglobin ≥ 90 g/L;
  • Hepatic and renal function: Albumin level ≥ 3.0 g/dL, total bilirubin ≤ 1.5×upper limit of normal(ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN, alkaline phosphatase ≤ 2.5×ULN, blood urea nitrogen and serum creatinine ≤ 1.5×ULN or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula);
  • Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
  • Echocardiogram (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%;
  • QTcF ≤ 470 msec;
  • Pregnancy tests must be performed within 7 days prior to treatment initiation for premenopausal women of childbearing potential. Serum pregnancy tests must be negative, and participants must not be breastfeeding. All enrolled patients must use adequate barrier contraception throughout the treatment cycle and for 6 months post-treatment;
  • Voluntary participation in the study, signed informed consent, good compliance, and willingness to attend follow-up visits and undergo study-related procedures.

Who cannot join

  • Breast cancer not confirmed by histopathological examination;
  • Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
  • Prior receipt of any form of antitumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
  • Concurrent administration of any other form of antitumor therapy;
  • History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ;
  • Participation in other drug clinical trials within 4 weeks prior to randomization;
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  • Administration of live or attenuated vaccines within 4 weeks prior to randomization;
  • Undergone major non-breast cancer-related surgical procedures within 4 weeks prior to randomization, or not yet fully recovered from such procedures;
  • Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence, including but not limited to: autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects controllable solely with hormone replacement therapy may be included); subjects with skin conditions not requiring systemic treatment such as vitiligo, psoriasis, or alopecia; controlled type 1 diabetes managed with insulin therapy; or childhood asthma in complete remission requiring no intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators;
  • History of immunodeficiency disorders, including HIV-positive status, other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
  • Uncontrolled or significant cardiovascular or cerebrovascular disease, including (but not limited to): occurrence of any of the following within 6 months prior to first dosing: congestive heart failure (NYHA Class III or IV), myocardial infarction or cerebral infarction (excluding lacunar infarction), pulmonary embolism, unstable angina, or presence of treatable arrhythmia at screening; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy); History of clinically significant QTc prolongation, second-degree type II atrioventricular block or third-degree atrioventricular block, or QTc interval (F method) >470 msec (females); atrial fibrillation (EHRA classification ≥2b); uncontrolled hypertension deemed unsuitable for study participation by the investigator;
  • Subjects with known or suspected interstitial pneumonia; other conditions within three months prior to first dosing that may interfere with interfering with drug-related pulmonary toxicity monitoring or management, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obstructive bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung disease, or any autoimmune, connective tissue, or inflammatory disease affecting the lungs, such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis, or prior history of total lung replacement;
  • Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA above upper limit of normal range), or cirrhosis; or severe infections requiring antibiotics, antivirals, or antifungals for control;
  • Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hemophilia, coagulation disorders, etc.);
  • Known allergy or contraindication to the study drug or its excipients;
  • Pregnant or lactating female patients; female patients of childbearing potential with a positive baseline pregnancy test; or female patients of childbearing potential unwilling to use effective contraception throughout the study period;
  • Concomitant conditions judged by the investigator to pose a serious threat to patient safety or interfere with study completion (including but not limited to uncontrolled severe hypertension, severe diabetes, active infections, etc.);
  • History of defined neurological or psychiatric disorders, including epilepsy or dementia, or any other condition deemed by the investigator to make the patient unsuitable for this study.

About this study

This is a prospective, randomized, multi-cohort, Phase II clinical trial. The study plans to enroll 120 patients with early-stage or locally advanced, HR-positive, HER2-low breast cancer. The primary objective is to evaluate the efficacy and safety of SHR-A1811 with or without endocrine therapy compared to standard chemotherapy as neoadjuvant treatment.

Eligible subjects will be randomized centrally via an Interactive Web Response System (IWRS) using a block randomization method. Participants will be assigned in a 1:1:1 ratio to one of three treatment cohorts:

Read more

Cohort A: SHR-A1811 plus endocrine therapy (letrozole ± ovarian function suppression [OFS]) Cohort B: SHR-A1811 monotherapy Cohort C: Standard chemotherapy (investigator's choice of A/EC-T or TEC regimen)

Neoadjuvant Treatment:

Subjects in Cohorts A and B will receive 8 cycles of their assigned regimen. Subjects in Cohort C will receive standard chemotherapy as per the chosen protocol.

Treatment will continue until completion of the regimen, occurrence of unacceptable toxicity, withdrawal of consent, or discontinuation at the investigator's discretion.

Assessments:

Tumor imaging for efficacy evaluation will be performed every 2 cycles, with responses assessed according to RECIST v1.1 criteria. Subjects who complete neoadjuvant treatment and are deemed eligible for surgery will undergo surgical intervention within 4 weeks after treatment completion. Pathological response will be assessed from the surgical specimen. Both radiological and pathological evaluations will be based on the assessments conducted at the study site.

Adjuvant Therapy:

Following surgery, all subjects will receive standard adjuvant endocrine therapy as clinically indicated.

Conditions
Breast Cancer
Being tested
SHR-A1811, Letrozole, TAC/AC-T
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-A1811Drug

    Intravenous infusion at 4.8 mg/kg per dose, administered once every 3 weeks (Q3W). Each 3-week (21-day) period constitutes one treatment cycle, totaling 8 cycles.

    Administration is via intravenous infusion. The initial infusion duration is 90±10 minutes (including the flush phase).

    If no infusion-related reactions occur after the first administration, subsequent infusions may be shortened to approximately 30 minutes (not less than 20 minutes, including the flush phase).

  • LetrozoleDrug

    2.5 mg orally once daily, taken continuously.

  • TAC/AC-TDrug

    Recommended standard dose

Study groups in NCT07305246
Study groupRoleWhat they receive
SHR-A1811 Combined with Endocrine TherapyExperimentalNot described
Receives: Drug: SHR-A1811; Drug: Letrozole
SHR-A1811ExperimentalNot described
Receives: Drug: SHR-A1811
Standard Chemotherapy GroupActive comparatorNot described
Receives: Drug: TAC/AC-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tpCR：ypT0-is/ypN0

    Measured: From enrollment to the end of surgery

Secondary outcomes (2)

  1. ORR

    Measured: From enrollment to the end of treatment，an average of 1 year

  2. EFS

    Measured: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07305246
Sponsor's protocol ID
MA-BC-II-122
Status last verified
Dec 2025
First submitted
26 Nov 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A1811, Letrozole and TAC/AC-T in people with Breast Cancer, run by First Hospital of China Medical 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 14 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 26 Dec 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tpCR：ypT0-is/ypN0 (time frame: From enrollment to the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07305246.

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 26 Dec 2025.

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