A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

August 14, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of TQB2102 for Injection for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zhimin Shao, Doctor
  • Phone Number: 13524514617
  • Email: szm@163.com

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Chongqing Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • Guizhou Cancer Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Harbin Medical University Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Liaoning Cancer Hospital & Institute
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntarily participate in this study and sign informed consent;
  • Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; expected survival of more than 3 months;
  • Histologically confirmed invasive breast cancer, no history of any systemic anti-tumor therapy for breast cancer;
  • Confirmed as HER2 positive;
  • Clinical stage at the time of visit is T0-4, N1-3, M0 or T2-4, N0, M0;
  • Agree to undergo breast cancer surgery when reaching the surgical criteria after neoadjuvant therapy;
  • Major organ functions are good, meeting certain criteria;
  • Agree to use contraception during the study and within 6 months after the study ends; female patients must have a negative serum pregnancy test within 7 days before enrollment and must be non-lactating.

Exclusion Criteria:

  • IV stage metastatic breast cancer or deemed unable to achieve curative surgical resection through neoadjuvant therapy by other investigators.
  • Bilateral invasive breast cancer.

  • Coexisting diseases and medical history:

    1. History of invasive breast cancer.
    2. Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
    3. Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
    4. Unhealed wounds or fractures.
    5. Ocular diseases deemed clinically significant by the investigator.
    6. Occurrence of arterial/deep venous thrombotic events within the last 6 months.
    7. History of substance abuse with inability to quit or individuals with mental disorders.
    8. ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
    9. Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
    10. History of interstitial lung disease/pneumonia requiring intervention with steroid treatment, or current presence, or suspected interstitial lung disease/pneumonia during the screening period that cannot be ruled out by the investigator; individuals with pulmonary diseases deemed unsuitable for participation by the investigator.

  • Tumor-related symptoms and treatment:

    1. Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.
    2. Received traditional Chinese medicine treatment with indications for anti-tumor effects within 2 weeks before the start of the study.
    3. Radiological evidence of tumor invasion into major vessels or judged by the investigator to be highly likely to invade major vessels during the subsequent study period, leading to fatal hemorrhage.

  • Study treatment-related:

    1. Experienced severe hypersensitivity reactions after using monoclonal antibodies.
    2. Developed uncontrollable active autoimmune diseases within 2 weeks before the start of the study.
    3. Allergic to any component or excipient in any study drug.
  • Participated in other clinical trials of anti-tumor drugs within 4 weeks before the start of the study.
  • Deemed inappropriate for inclusion based on the investigator's judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 6 mg/kg of TQB2102 for injection
6 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles.
Drug: 6.0 mg/kg of TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.
Experimental: 7.5 mg/kg of TQB2102 for injection
7.5 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles.
Drug: 7.5 mg/kg of TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total physiological complete response (tpCR)
Time Frame: Up to 12 months.
The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer and the regional lymph nodes are negative.
Up to 12 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breast pathological complete (bpCR) response
Time Frame: Up to 12 months.
The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer.
Up to 12 months.
Objective response rate (ORR)
Time Frame: Up to 12 months.
The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Up to 12 months.
The occurrence rate of all adverse events (AEs)
Time Frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
The severity of all adverse events (AEs)
Time Frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
The severity of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).
From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)
Time Frame: 1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 6 Day1, Cycle 8 Day1, and 90 days after the end of the last infusion. Each cycle is 21 days.
Incidence of anti-drug antibody (ADA)
1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 6 Day1, Cycle 8 Day1, and 90 days after the end of the last infusion. Each cycle is 21 days.
Event-free survival (EFS)
Time Frame: Up to 60 months.
The time from the date of surgery completion to the first occurrence of the following events，including disease progression precluding surgery, ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.
Up to 60 months.
Invasive Disease-free survival (IDFS)
Time Frame: Up to 60 months.
The time from the date of surgery completion to the first occurrence of the following events，including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, a second primary malignancy in a non-breast site, and death for any reason.
Up to 60 months.
Overall survival (OS)
Time Frame: Up to 60 months after study start
The time from the date of surgery completion to death due to any cause.
Up to 60 months after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TQB2102-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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