Breast CancerPhase 3NCT07003074
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
A Phase 3 study testing TQB2102 for Injection and Docetaxel combined + Trastuzumab +Pertuzumab in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 25 sites in China.
Trial summary
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively. 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?
- TQB2102 for Injection and Docetaxel combined + Trastuzumab +Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 642 participants
- Where
- 25 sitesChina
- Study dates
- 23 Jun 2025to Jul 2030
- Phase
- Phase 3
- 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
- Subjects voluntarily enrolled in this study with good compliance
- Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1
- HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology
- Defined hormone receptor (HR) status
- Has not received systemic anti-tumor therapy during the recurrence/metastasis stage (acceptable ≤ first-line endocrine therapy)
- If receiving (new) adjuvant therapy, it is required that the time interval between the end of systemic therapy (excluding endocrine therapy) and the discovery of recurrence/metastasis be greater than 12 months
- Have at least one measurable lesion according to RECIST 1.1 criteria;
- Good major organ function
Who cannot join
- It is known that there is spinal cord compression or active central nervous system metastasis;
- Subjects with only skin and/or brain lesions as target lesions
- Combined diseases and medical history
- Have had or currently have other malignant tumors within the past 5 years of randomization
- Unrelieved toxic reactions above Common Terminology Criteria (CTC) AE grade 1 caused by any previous treatment
- Received major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to randomization
Show all 35Show fewer
- There are diseases that affect intravenous injection and venous blood collection
- There are congenital bleeding and coagulation disorders present
- An arterial/deep vein thrombosis event occurred within 6 months prior to the first administration
- Poor blood pressure control
- Suffering from significant cardiovascular disease
- There is an uncontrolled infection of ≥ CTC AE grade 2 within 14 days before the start of treatment
- History of interstitial lung disease/pneumonia (non infectious) requiring steroid medication intervention in the past
- Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first administration
- Active viral hepatitis with poor control
- Active syphilis infected individuals in need of treatment
- Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
- Immunosuppressants or systemic or absorbable local hormone therapy are required to achieve immunosuppression
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases
- Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g
- Patients with renal failure requiring hemodialysis or peritoneal dialysis
- Poor control of diabetes
- Individuals with epilepsy who require treatment
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders
- Tumor related symptoms and treatment
- There is a third interstitial fluid accumulation or cancerous lymphangitis that cannot be controlled by drainage or other methods
- History of cumulative dose exposure to anthracyclines in the past
- Received radiation therapy within 3 weeks prior to the start of study treatment and endocrine therapy within 2 weeks prior to the start of study treatment
- Traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the start of the study treatment
- Research treatment related
- Previously received antibody conjugate therapy consisting of topoisomerase I inhibitors,;
- Allergic to any research drug or any ingredient or excipient in the drug;
- Individuals who experience severe hypersensitivity reactions after using monoclonal antibodies;
- Participated in other clinical trials of anti-tumor therapy within 4 weeks before the start of the research treatment.
- According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
China25 sites, 25 recruiting
- Not yet recruiting
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
Wenyan Wang, Doctor, 13521193449, wwyan89@sina.com
- Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130000
Jiuwei Cui, Doctor, 15843073215, jdyycjw@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Quchang OuYang, Doctor, 13973135318, ouyangquchang@hnca.org.cn
- Not yet recruiting
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116000
Xiang Li, Master, 18018931093, 94207842@qq.com
- Not yet recruiting
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116000
Ruoyu Wang, Doctor, 13942875869, wry1963@soho.com
- Not yet recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Qingyuan Zhang, Doctor, 13313612989, ns86298333@163.com
- Not yet recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Shikai Hong, Doctor, 18963789035, shikhong@163.com
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
Nannan Lu, Doctor, 18130056850, lnn279@ustc.edu.cn
- Not yet recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Huihui Li, Doctor, 15553103209, 15553103209@163.com
- Not yet recruiting
Huaihe Hospital of Henan University
Kaifeng, Henan, 475099
Hong Lu, Doctor, 138337850019, hhyyluhong@126.com
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Yanxiang Guo, Bachelor, 13919409550, 35956138@qq.com
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Xiaorong Bai, Bachelor, 13893217378, 13893217378@163.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Yongmei Yin, Doctor, 13951842727, ym.yin@hotmail.com
- Not yet recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Wenbin Yue, Doctor, 13839276125, yuewenbin2013@163.com
- Not yet recruiting
Fudan University shanghai cancer center
Shanghai, Shanghai Municipality, 201321
Zhimin Shao, Doctor, 18017312288, szm@163.com
- Not yet recruiting
Shantou Central Hospital
Shantou, Guangdong, 515031
Zhiyong Wu, Doctor, 13502953050, stwuzy@163.com
- Not yet recruiting
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, 110000
Tao Sun, Doctor, 13940404526, lnzlrxnsy@163.com
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Guohui Han, Master, 13754858188, 13754858188@163.com
- Not yet recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300060
Chunfang Hao, Doctor, 13602031629, haochf@163.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Yehui Shi, Doctor, 18622221183, shiyehui@tjmuch.com
- Not yet recruiting
The Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 831399
Bing Zhao, Doctor, 13899908184, 819502412@qq.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 434000
HaiJun Yu, Doctor, 13971665181, doctoryhj@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi'An Jiaoting Yniversity
Xi'an, Shaanxi, 710000
Jin Yang, Doctor, 18991232383, Yj_Clinicalstudy@163.com
- Not yet recruiting
Yuncheng Central Hospital, Shanxi Province
Yuncheng, Shanxi, 044099
Xiaoke Hou, Master, 17703591026, hxk13720980018@163.com
- Not yet recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000
Lige Yao, Master, 13693718212, 577663634@qq.com
About this study
Official title: A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.
- Conditions
- Breast Cancer
- Being tested
- TQB2102 for Injection, Docetaxel combined + Trastuzumab +Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 for InjectionDrug
TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer.
Docetaxel combined + Trastuzumab +PertuzumabDrug
Positive control.
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 for Injection | Experimental | Administer by intravenous infusion, with a 21-day treatment cycle. Receives: Drug: TQB2102 for Injection |
| Docetaxel combined + Trastuzumab +Pertuzumab | Active comparator | Docetaxel: 75mg/m2, administered once every 3 weeks, intravenous infusion for 60 minutes, for a total of 6 cycles; Trastuzumab: The initial loading dose is 8mg/kg, and 6mg/kg is administered every 3 weeks thereafter; Pertuzumab: initial loading dose of 840mg, intravenous infusion for 60 minutes; Afterwards, administer 420mg every 3 weeks. After each infusion of pertuzumab, it is recommended to observe for 30-60 minutes. After the observation, trastuzumab or chemotherapy can be continued. Receives: Drug: Docetaxel combined + Trastuzumab +Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Measured: Up to approximately 30 months
Progression-Free Survival
It refers to the time between enrollment and the occurrence of objective disease progression or death caused by various reasons (whichever occurs first).
Measured: Up to approximately 30 months
Secondary outcomes (8)
Overall Survival
It refers to the time between enrollment and death caused by various reasons.
Measured: Up to approximately 30 months
Duration of Remission
The subjects with the best response determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as complete response (CR) or partial response (PR) are defined as the period from the first recorded tumor response to the first recorded disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 30 months
The incidence of adverse events
During the period from the signing of the informed consent form by the subjects to 28 days after the last dose of medication/initiation of new anti-tumor treatment (based on the first occurrence), the incidence of adverse events was recorded according to the common adverse event (AE) evaluation criteria of the National Cancer Institute (NCI CTC AE 5.0 version).
Measured: Up to approximately 52 months
The severity of adverse events
During the period from the signing of the informed consent form by the subjects to 28 days after the last dose of medication/initiation of new anti-tumor treatment (based on the first occurrence), the severity of adverse events was recorded according to the common AE evaluation criteria of the National Cancer Institute (NCI CTCAE 5.0 version).
Measured: Up to approximately 52 months
Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102
To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb)
The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb)
Measured: within 60 minutes prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8, Cycle16,and before administration and 28 days (± 7 days), (21 days as a treatment cycle)
Total antibodies
To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
The small molecule toxin TQ22723
To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start23 Jun 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 642 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003074
- Sponsor's protocol ID
- TQB2102-III-06
- Status last verified
- Apr 2025
- First submitted
- 21 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07003074
- Acronym / sponsor ID
- TQB2102-III-06
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 642 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 4 Jun 2025 (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.
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2102 for Injection | Experimental | Drug: TQB2102 for InjectionAdminister by intravenous infusion, with a 21-day treatment cycle. |
| Docetaxel combined + Trastuzumab +Pertuzumab | Active comparator | Drug: Docetaxel combined + Trastuzumab +PertuzumabDocetaxel: 75mg/m2, administered once every 3 weeks, intravenous infusion for 60 minutes, for a total of 6 cycles; Trastuzumab: The initial loading dose is 8mg/kg, and 6mg/kg is administered every 3 weeks thereafter; Pertuzumab: initial loading dose of 840mg, intravenous infusion for 60 minutes; Afterwards, administer 420mg every 3 weeks. After each infusion of pertuzumab, it is recommended to observe for 30-60 minutes. After the observation, trastuzumab or chemotherapy can be continued. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily enrolled in this study with good compliance
- Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1
- HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology
- Defined hormone receptor (HR) status
- Has not received systemic anti-tumor therapy during the recurrence/metastasis stage (acceptable ≤ first-line endocrine therapy)
Key exclusion criteria (35 listed)
- It is known that there is spinal cord compression or active central nervous system metastasis;
- Subjects with only skin and/or brain lesions as target lesions
- Combined diseases and medical history
- Tumor related symptoms and treatment
- Research 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 |
|---|---|---|
| TQB2102 for InjectionTQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer. | Drug | TQB2102 for Injection |
| Docetaxel combined + Trastuzumab +PertuzumabPositive control. | Drug | Docetaxel combined + Trastuzumab +Pertuzumab |
Primary outcome
Objective Response Rate
Time frame: Up to approximately 30 months
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Progression-Free Survival
Time frame: Up to approximately 30 months
It refers to the time between enrollment and the occurrence of objective disease progression or death caused by various reasons (whichever occurs first).
8 secondary outcomes
Overall Survival
Time frame: Up to approximately 30 months
Duration of Remission
Time frame: Up to approximately 30 months
The incidence of adverse events
Time frame: Up to approximately 52 months
The severity of adverse events
Time frame: Up to approximately 52 months
Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: within 60 minutes prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8, Cycle16,and before administration and 28 days (± 7 days), (21 days as a treatment cycle)
Total antibodies
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
The small molecule toxin TQ22723
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
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 25 Jun 2025.
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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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2102 for Injection and Docetaxel combined + Trastuzumab +Pertuzumab in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 25 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 35 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Zhimin Shao, Doctor (18017312288, szm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to approximately 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.