SHR-A1811 versus standard neoadjuvant therapy for early or locally advanced HER2-positive breast cancer

A Randomized, Open-label, Multicenter Phase III Study of SHR-A1811 Compared to Docetaxel+Carboplatin+Trastuzumab+Pertuzumab as a Neoadjuvant Therapy for the Initial Treatment of Early-stage or Locally Advanced HER2-positive Breast Cancer

This trial will test whether giving SHR-A1811 before surgery works as well as or better than the standard TCbHP regimen for women with early-stage or locally advanced HER2-positive breast cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 740 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Shenyang, Liaoning and 1 other locations)
• Trial ID: NCT07196774 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label Phase 3 study enrolling 650 women who will be assigned 1:1 to receive neoadjuvant SHR-A1811 or the TCbHP regimen (docetaxel, carboplatin, trastuzumab, pertuzumab). Participants who complete neoadjuvant therapy and are operable will proceed to surgery, and tumor response will be centrally reviewed by an independent review committee and local pathologists. The primary endpoint is total pathologic complete response (tpCR) assessed by the IRC, and patients who undergo surgery will be followed for at least three years for event-free survival, disease-free survival, and distant disease-free survival. The trial is conducted at multiple cancer centers in China and is open-label.

Who should consider this trial

Good fit: Women aged 18–75 with previously untreated, pathologically confirmed HER2-positive early-stage or locally advanced breast cancer, ECOG 0–1, acceptable laboratory results, a negative pregnancy test, and informed consent are the intended candidates.

Not a fit: Patients who are HER2-negative, have prior systemic anti-cancer treatment, significant comorbidities or immune-modulating treatments, recent transplants or vaccines within specified windows, are pregnant or breastfeeding, or otherwise meet exclusion criteria are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If SHR-A1811 is superior or noninferior, it could increase rates of complete tumor clearance before surgery and potentially improve long-term outcomes for HER2-positive patients.

How similar studies have performed: Dual HER2-targeted neoadjuvant regimens such as trastuzumab plus pertuzumab with chemotherapy have improved pCR rates, but SHR-A1811 is a newer agent with limited published phase 3 data so far.

Eligibility criteria

Inclusion Criteria:

1. Females treated for the first time, 18-75 years old;
2. ECOG score 0-1;
3. Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
4. Results of laboratory tests meet the enrollment requirements;
5. Pregnancy test result must be negative and must agree to contraception;
6. Has signed the informed consent form.

Exclusion Criteria:

1. Confirmed HER2 negative;
2. Has tumor-related medical history or treatment history;
3. Has severe combined disease/medical history and treatment history;
4. Has received treatment with systemic immunostimulants or immunosuppressants;
5. Be allergic to the test drug;
6. Participate in other clinical trials simultaneously;
7. Has received vaccine within 30 days before the first dose;
8. Has received allograft bone marrow transplantation;
9. Has given birth within one year or is breastfeeding;
10. Has history of psychological drug abuse, alcoholism or drug use.

Where this trial is running

Shenyang, Liaoning and 1 other locations

• Shengjing Hospital, China Medical University — Shenyang, Liaoning, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yang Wu

Conditions Early-stage or Locally Advanced HER2-positive Breast Cancer