Breast CancerPhase 3NCT06561607
A Clinical Trial of TQB2102 for Injection in the Treatment of HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
A Phase 3 study testing TQB2102 for Injection and Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel) in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 34 sites in China.
Trial summary
The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent metastatic stage who have not received chemotherapy. 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 Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 34 sitesChina
- Study dates
- 11 Oct 2024to Dec 2028
- 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;
- Pathologically confirmed locally advanced or metastatic breast cancer with low HER2 expression and unresectable:
- Defined hormone receptor (HR) status.
- Imaging-confirmed disease progression (during or after completion of the most recent treatment);
- Have at least one measurable lesion according to RECIST 1.1 criteria;
- Good major organ function.
Who cannot join
- The presence or current concurrent presence of other malignant tumors within 5 years prior to randomization. ;
- Unresolved toxic reactions above Common Terminology Criteria (CTC) for Adverse Events (AE) grade 1 due to any prior therapy;
- Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the pre-randomization period;
- Prolonged unhealed wounds or fractures;
- Previous history of interstitial lung disease/pneumonia requiring steroidal drug intervention;
- The presence of moderate to severe pulmonary dysfunction/disease within 3 months prior to randomization;
Show all 28Show fewer
- The presence of an arterial/deep vein thrombotic event within 6 months prior to randomization;
- The presence of a medical condition that interferes with intravenous administration, intravenous blood collection, or inability to swallow, chronic diarrhea, intestinal obstruction, or the presence of other factors that interfere with the administration and absorption of medications;
- The presence of grade ≥2 myocardial ischemia or myocardial infarction, cardiac arrhythmias (including QT corrected (QTc) ≥450ms (men) and QTc ≥470ms (women)) and grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification); angina pectoris requiring antianginal medication; and clinically significant heart valve disease;
- Active or uncontrolled ≥ CTC AE grade 2 infection present within 14 days prior to randomization;
- Cirrhosis of the liver, active hepatitis that is not well controlled;
- Renal failure requiring hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Those with routine urinalysis suggestive of urinary protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g;
- Those who have used immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization;
- Those with a history of psychotropic substance abuse that cannot be abstained from or those with psychiatric disorders;
- Tumor-related symptoms and treatments:
- Subjects who have been treated with other antineoplastic agents such as chemotherapy, radical radiotherapy, or immunotherapy within 4 weeks prior to randomization, or who are still within 5 half-lives of the drug (whichever occurs shortest);
- Treatment with endocrine therapy, molecularly targeted therapy, or a proprietary Chinese medicine with an anti-tumor indication as specified in the National Medical Products Administration (NMPA) approved drug insert within 2 weeks prior to randomization;
- Presence of carcinomatous lymphadenitis, or uncontrollable pleural effusion, ascites, and pericardial effusion of moderate volume or greater that requires repeated drainage to relieve clinical symptoms, or who have received drainage of plasmapheresis for therapeutic purposes within 2 weeks prior to randomization;
- Known carcinomatous meningitis or clinically active central nervous system metastases;
- Severe bone damage resulting from tumor bone metastases;
- Those who have received a control chemotherapeutic agent of the investigator's choice during the recurrent metastatic phase or for whom a control chemotherapeutic agent of the investigator's choice is inappropriate for reasons such as intolerance or contraindication to that agent;
- Has received prior anti-HER2 therapy;
- Who have developed hypersensitivity to humanized monoclonal antibody products;
- Those who have developed an allergy to any of the study drugs or any component or excipient in the drugs;
- Who have participated in and used another antitumor clinical trial drug within 4 weeks prior to randomization;
- Subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or who are deemed to have other reasons for being unsuitable for enrollment.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites
AnYang Tumor Hospital
Anyang, Henan, 455100
Affiliated Hospital of Hebei University
Baoding, Hebei
Baoji Central Hospital
Baoji, Shanxi, 721008
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
Binzhou Medical College Affiliated Hospital
Binzhou, Shandong, 256699
Binzhou People's Hospital
Binzhou, Shandong, 310053
Chengde Central Hospital
Chengde, Hebei, 067024
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24099
The Second Hospital of DALIAN Medical University
Dalian, Liaoning, 116000
Sun Yet-Sen University Cancer Certer
Guangzhou, Guangdong, 510000
Guigang City People'S Hospital
Guigang, Guangxi, 537100
The Affiliated Cancer Hospital of Guizhou Medical University Co., LTD
Guiyang, Guizhou, 550000
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, 570102
Hainan General Hospital
Haikou, Hainan, 570311
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310004
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
AnHui Province Hospital West District
Hefei, Anhui, 230000
The first Affiliated hospital of anhui medical university
Hefei, Anhui, 230000
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Hennan, 471003
Affiliated Hospital of North Scichuan Medical College
Nanchong, Sichuan, 637000
Cancer Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021
The First affiliated hospital of GuangXi medical university
Nanning, Guangxi, 530021
Fujian Medical University 2nd Affiliated Hospital
Quanzhou, Fujian, 362000
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200082
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430034
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 730000
Zhangzhou Hospital in Fujian Province
Zhangzhou, Fujian, 363000
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
Henan Cancar Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Randomized, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent metastatic stage who have not received chemotherapy. The primary objective of the study is to determine the efficacy and safety of TQB2102 compared to investigator-selected single-agent chemotherapy in the target population. 542 subjects with HER2 immunohistochemistry (IHC )2+/ in situ hybridization (ISH)- and IHC 1+ (HER2-low) expression will be enrolled in 1:1 randomized groups to receive TQB2102 or investigator's choice of single-agent chemotherapy (capecitabine, paclitaxel, or albumin-paclitaxel) until progression of disease (PD), as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1. 1, unless there are unacceptable toxicity, withdrawal of consent, or meeting other discontinuation criteria.
- Conditions
- Breast Cancer
- Being tested
- TQB2102 for Injection, Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)
- 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 (ADC) drug proposed for patients with HER2 low-expressing breast cancer.
Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)Drug
Based on each patient's condition and previous treatment history, the investigator will select one of the chemotherapy drugs for treatment.
- Capecitabine: 1000-1250 mg/m2 twice daily, administered consecutively on day 1-14, 21 days as a treatment cycle.
- Paclitaxel: 175 mg/m2, IV infusion, administered Day1 per cycle, 21 days as a treatment cycle. OR 80 mg/m2 by IV infusion administered weekly.
- Albumin Paclitaxel: 260 mg/m2, IV infusion, administered every cycle of Day1 for 21 days as a treatment cycle. 100 mg/m2 or 125 mg/m2, IV infusion, administered every cycle of Day 1 and Day 8 for 21 days as a treatment cycle; or Day 1, Day 8, and Day 15 administered every cycle for 28 days as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 for Injection | Experimental | Administered by intravenous drip, 7.5 mg/kg per dose, 21 days as a treatment cycle. Receives: Drug: TQB2102 for Injection |
| Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel) | Active comparator | Based on each patient's condition and previous treatment history, the investigator will select one of the following chemotherapy drugs for treatment.
* Capecitabine
* Paclitaxel
* Albumin Paclitaxel Receives: Drug: Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)
Designed to demonstrate that in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy.
Measured: Up to 25 months
Secondary outcomes (14)
Progression-free survival (PFS) in subjects with HER2 low-expressing recurrent/metastatic breast cancer as assessed by IRC
Designed to demonstrate that in subjects with HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy.
Measured: Up to 25 months
Progression-free survival (PFS) as assessed by investigators in the HR-positive, HER2 low-expressing population
To evaluate progression-free survival (PFS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Investigator-assessed overall survival (OS) in HR-positive, low HER2-expressing population.
To evaluate the overall survival (OS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Overall survival (OS) as assessed by investigators in the HR-positive, HER2 low-expressing population
To evaluate the objective remission rate (ORR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Duration of remission (DOR) as assessed by investigators in the HR-positive, HER2 low-expressing population
To evaluate the duration of remission (DOR) of injectable TQB2102 compared to investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Investigator-assessed clinical benefit rate (CBR) in the HR-positive, low HER2-expressing population
To evaluate the clinical benefit rate (CBR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Progression-free survival (PFS) as assessed by investigators in the HER2 low expression population
To evaluate progression-free survival (PFS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Overall survival (OS) as assessed by investigators in the HER2 low expression population
To evaluate the overall survival (OS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Duration of remission (DOR) as assessed by investigators in the HER2 low expression population
To evaluate the duration of remission (DOR) of injectable TQB2102 compared to investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Objective remission rate (ORR) as assessed by investigators in the HER2 low expression population
To evaluate the objective remission rate (ORR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Clinical benefit rate (CBR) as assessed by investigators in the HER2 low expression population
To evaluate the clinical benefit rate (CBR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Measured: Up to 25 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests
To evaluate the safety of TQB2102 for Injection compared to investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer, including: the incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs).
Measured: Up to 52 months
Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102, total antibodies, and 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.
Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 .
Measured: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle).
Immunogenicity of TQB2102: ADA incidence
To evaluate the immunogenicity (ADA) of TQB2102 for injection in subjects with HER2 low expression recurrent/metastatic breast cancer.
Measured: Prior to (-60 min) the first day of dosing in Cycle 1, Cycle 2, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle), and at follow-up 30 days (±7 days) after the last dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start11 Oct 2024
- Primary completionJan 2027 (estimated)
- Study completionDec 2028 (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 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
- 542 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
- NCT06561607
- Sponsor's protocol ID
- TQB2102-III-01
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2024
- Last updated
- 10 Sep 2026
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06561607
- Acronym / sponsor ID
- TQB2102-III-01
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Aug 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.
The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent metastatic stage who have not received chemotherapy. The primary objective of the study is to determine the efficacy and safety of TQB2102 compared to investigator-selected single-agent chemotherapy in the target population. 542 subjects with HER2 immunohistochemistry (IHC )2+/ in situ hybridization (ISH)- and IHC 1+ (HER2-low) expression will be enrolled in 1:1 randomized groups to receive TQB2102 or investigator's choice of single-agent chemotherapy (capecitabine, paclitaxel, or albumin-paclitaxel) until progression of disease (PD), as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1. 1, unless there are unacceptable toxicity, withdrawal of consent, or meeting other discontinuation criteria.
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 InjectionAdministered by intravenous drip, 7.5 mg/kg per dose, 21 days as a treatment cycle. |
| Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel) | Active comparator | Drug: Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)Based on each patient's condition and previous treatment history, the investigator will select one of the following chemotherapy drugs for treatment. * Capecitabine * Paclitaxel * Albumin Paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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;
- Pathologically confirmed locally advanced or metastatic breast cancer with low HER2 expression and unresectable:
- Defined hormone receptor (HR) status.
- Imaging-confirmed disease progression (during or after completion of the most recent treatment);
Key exclusion criteria (28 listed)
- The presence or current concurrent presence of other malignant tumors within 5 years prior to randomization. ;
- Unresolved toxic reactions above Common Terminology Criteria (CTC) for Adverse Events (AE) grade 1 due to any prior therapy;
- Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the pre-randomization period;
- Prolonged unhealed wounds or fractures;
- Previous history of interstitial lung disease/pneumonia requiring steroidal drug intervention;
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 (ADC) drug proposed for patients with HER2 low-expressing breast cancer. | Drug | TQB2102 for Injection |
| Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)Based on each patient's condition and previous treatment history, the investigator will select one of the chemotherapy drugs for treatment. * Capecitabine: 1000-1250 mg/m2 twice daily, administered consecutively on day 1-14, 21 days as a treatment cycle. * Paclitaxel: 175 mg/m2, IV infusion, administered Day1 per cycle, 21 days as a treatment cycle. OR 80 mg/m2 by IV infusion administered weekly. * Albumin Paclitaxel: 260 mg/m2, IV infusion, administered every cycle of Day1 for 21 days as a treatment cycle. 100 mg/m2 or 125 mg/m2, IV infusion, administered every cycle of Day 1 and Day 8 for 21 days as a treatment cycle; or Day 1, Day 8, and Day 15 administered every cycle for 28 days as a treatment cycle. | Drug | Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel) |
Primary outcome
Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)
Time frame: Up to 25 months
Designed to demonstrate that in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy.
14 secondary outcomes
Progression-free survival (PFS) in subjects with HER2 low-expressing recurrent/metastatic breast cancer as assessed by IRC
Time frame: Up to 25 months
Progression-free survival (PFS) as assessed by investigators in the HR-positive, HER2 low-expressing population
Time frame: Up to 25 months
Investigator-assessed overall survival (OS) in HR-positive, low HER2-expressing population.
Time frame: Up to 25 months
Overall survival (OS) as assessed by investigators in the HR-positive, HER2 low-expressing population
Time frame: Up to 25 months
Duration of remission (DOR) as assessed by investigators in the HR-positive, HER2 low-expressing population
Time frame: Up to 25 months
Investigator-assessed clinical benefit rate (CBR) in the HR-positive, low HER2-expressing population
Time frame: Up to 25 months
Progression-free survival (PFS) as assessed by investigators in the HER2 low expression population
Time frame: Up to 25 months
Overall survival (OS) as assessed by investigators in the HER2 low expression population
Time frame: Up to 25 months
Duration of remission (DOR) as assessed by investigators in the HER2 low expression population
Time frame: Up to 25 months
Objective remission rate (ORR) as assessed by investigators in the HER2 low expression population
Time frame: Up to 25 months
Clinical benefit rate (CBR) as assessed by investigators in the HER2 low expression population
Time frame: Up to 25 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests
Time frame: Up to 52 months
Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102, total antibodies, and the small molecule toxin TQ22723
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle).
Immunogenicity of TQB2102: ADA incidence
Time frame: Prior to (-60 min) the first day of dosing in Cycle 1, Cycle 2, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle), and at follow-up 30 days (±7 days) after the last dosing.
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 10 Sep 2026.
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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.
34 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 Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel) in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 34 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 7 inclusion and 28 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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?
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?
Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC) (time frame: Up to 25 months). 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 10 Sep 2026.