Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07196774

A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer

This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Early-stage or Locally Advanced HER2-positive Breast Cancer

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Shengjing Hospital, China Medical University, Shenyang, Liaoning, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SHR-A1811 for Injection

Drug

SHR-A1811 for injection.

Docetaxel Injection

Drug

Docetaxel injection.

Trastuzumab Injection

Drug

Trastuzumab injection.

Carboplatin for Injection

Drug

Carboplatin for injection.

Pertuzumab Injection

Drug

Pertuzumab injection.

Primary outcomes

  1. Postoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments.

    Time frame: From the enrollment of the first subject to the end of the study, it lasted about 36 months.

Secondary outcomes

  1. Postoperative total pathologic complete response (tpCR) evaluated pathologists at the research center after finishing neoadjuvant treatments.

    Time frame: From the enrollment of the first subject to the end of the study, it lasted about 36 months.

  2. Event-free survival (EFS).

    Time frame: Followed up for at least 3 years.

  3. Disease-free survival (DFS).

    Time frame: Followed up for at least 3 years.

  4. Distant disease-free survival (DDFS).

    Time frame: Followed up for at least 3 years.

  5. Objective response rate (ORR) assessed according to the preoperative evaluation utilizing RECIST v1.1 after finishing neoadjuvant treatments.

    Time frame: Followed up for at least 3 years.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 29, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.