Breast CancerPhase 2NCT06198751
A Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
A Phase 2 study testing 6.0 mg/kg of TQB2102 for injection and 7.5 mg/kg of TQB2102 for injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
Trial summary
To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 6.0 mg/kg of TQB2102 for injection and 7.5 mg/kg of TQB2102 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 7 sitesChina
- Study dates
- 5 Feb 2024to Feb 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- History of invasive breast cancer.
- Occurrence of any other malignant tumors within the last 3 years or current simultaneous presence.
- Underwent significant surgical treatment, incisional biopsy, or significant trauma within 28 days before the start of the study.
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- Unhealed wounds or fractures.
- Ocular diseases deemed clinically significant by the investigator.
- Occurrence of arterial/deep venous thrombotic events within the last 6 months.
- History of substance abuse with inability to quit or individuals with mental disorders.
- ≥ Grade 2 myocardial ischemia or infarction, arrhythmias, or ≥ Grade 2 congestive heart failure.
- Uncontrolled ≥ CTCAE Grade 2 infection within 14 days before the start of the study.
- 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:
- Received surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the start of the study.
- Received traditional Chinese medicine treatment with indications for anti-tumor effects within 2 weeks before the start of the study.
- 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:
- Experienced severe hypersensitivity reactions after using monoclonal antibodies.
- Developed uncontrollable active autoimmune diseases within 2 weeks before the start of the study.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Hunan Cancer Hospital
Changsha, Hunan, 410013
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Guizhou Cancer Hospital
Guiyang, Guizhou, 550001
Harbin medical university cancer hospital
Harbin, Heilongjiang, 150040
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- 6.0 mg/kg of TQB2102 for injection, 7.5 mg/kg of TQB2102 for injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6.0 mg/kg of TQB2102 for injectionDrug
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg.
7.5 mg/kg of TQB2102 for injectionDrug
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| 6 mg/kg of TQB2102 for injection | Experimental | 6 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles. Receives: Drug: 6.0 mg/kg of TQB2102 for injection |
| 7.5 mg/kg of TQB2102 for injection | Experimental | 7.5 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles. Receives: Drug: 7.5 mg/kg of TQB2102 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total physiological complete response (tpCR)
The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer and the regional lymph nodes are negative.
Measured: Up to 12 months.
Secondary outcomes (8)
Breast pathological complete (bpCR) response
The percentage of the patients where the primary breast lesion shows no residual infiltrating cancer.
Measured: Up to 12 months.
Objective response rate (ORR)
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.
Measured: Up to 12 months.
Event-free survival (EFS)
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.
Measured: Up to 60 months.
Invasive Disease-free survival (IDFS)
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.
Measured: Up to 60 months.
The occurrence rate of all adverse events (AEs)
The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
Measured: 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)
The severity of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).
Measured: 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)
Incidence of anti-drug antibody (ADA)
Measured: 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.
Overall survival (OS)
The time from the date of surgery completion to death due to any cause.
Measured: Up to 60 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start5 Feb 2024
- Primary completion8 May 2025
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198751
- Sponsor's protocol ID
- TQB2102-II-01
- Status last verified
- Feb 2025
- First submitted
- 27 Dec 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li JJ, Zhang WJ, Zeng XH, Zhang QY, Chen L, Wu J, Liu GY, Wang ZH, Hu XB, Hu YY, Li ZL, Shao ZM. Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial. J Clin Oncol. 2026 Jan;44(1):20-30. doi: 10.1200/JCO-25-01153. Epub 2025 Nov 25.
PubMed 41289548
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06198751
- Acronym / sponsor ID
- TQB2102-II-01
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 Jan 2024 (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.
To evaluate the efficacy and safety of neoadjuvant treatment with TQB2102 for injection in patients with Her2 positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 mg/kg of TQB2102 for injection | Experimental | Drug: 6.0 mg/kg of TQB2102 for injection6 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles. |
| 7.5 mg/kg of TQB2102 for injection | Experimental | Drug: 7.5 mg/kg of TQB2102 for injection7.5 mg/kg TQB2102, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, for 6 or 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (23 listed)
- 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:
- Tumor-related symptoms and treatment:
- Study treatment-related:
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 |
|---|---|---|
| 6.0 mg/kg of TQB2102 for injectionTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg. | Drug | 6 mg/kg of TQB2102 for injection |
| 7.5 mg/kg of TQB2102 for injectionTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 7.5 mg/kg. | Drug | 7.5 mg/kg of TQB2102 for injection |
Primary outcome
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.
8 secondary outcomes
Breast pathological complete (bpCR) response
Time frame: Up to 12 months.
Objective response rate (ORR)
Time frame: Up to 12 months.
Event-free survival (EFS)
Time frame: Up to 60 months.
Invasive Disease-free survival (IDFS)
Time frame: Up to 60 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 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.
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.
Overall survival (OS)
Time frame: Up to 60 months after study start
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 19 Aug 2025.
- Derived from this study: PubMed 41289548Li JJ, Zhang WJ, Zeng XH, Zhang QY, Chen L, Wu J, Liu GY, Wang ZH, Hu XB, Hu YY, Li ZL, Shao ZM. Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial. J Clin Oncol. 2026 Jan;44(1):20-30. doi: 10.1200/JCO-25-01153. Epub 2025 Nov 25.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6.0 mg/kg of TQB2102 for injection and 7.5 mg/kg of TQB2102 for injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
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 8 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Total physiological complete response (tpCR) (time frame: Up to 12 months.). 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 NCT06198751, which also lists 1 linked publication.
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 19 Aug 2025.