Breast CancerPhase 2NCT07136974
Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.
A Phase 2 study testing TQB2102 and Docetaxel + Carboplatin + Trastuzumab +Pertuzumab in people with Breast Cancer and HER2 + Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, HER2 + Breast Cancer
- What is being tested?
- TQB2102 and Docetaxel + Carboplatin + Trastuzumab +Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Aug 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years,
- ECOG performance status 0-1;
- Clinical T2-T4, or T1c with axillary lymph node metastasis; Confirmed HER2-positive status (per 2018 ASCO/CAP HER2 Testing Guidelines, defined as IHC 3+ or FISH positive);
- Clinically measurable lesion: Lesion measurable by ultrasound, mammography, or optional MRI within 1 month before randomization;
- No chemotherapy contraindications based on organ and bone marrow function tests within 1 month prior to chemotherapy: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, Hemoglobin ≥90 g/L, Platelet count ≥100×10⁹/L, Total bilirubin <1.5 × ULN (upper limit of normal), Creatinine <1.5 × ULN, AST/ALT <1.5 × ULN, Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;
- For women of childbearing potential: Negative serum pregnancy test within 14 days before randomization;
- Signed informed consent form.
Who cannot join
- Stage IV (metastatic) breast cancer;
- Prior treatments received including chemotherapy, endocrine therapy, targeted therapy, or radiotherapy; History of other malignancies within 3 years or concurrent malignancies. Exceptions: Other malignancies treated with surgery alone achieving ≥5-year disease-free survival (DFS) . Cured cervical carcinoma in situ or non-melanoma skin cancer;
- Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or incomplete recovery from such procedures;
- Significant cardiac disease or conditions including but not limited to: History of heart failure or systolic dysfunction (LVEF <50%). Uncontrolled high-risk arrhythmias: Atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (Mobitz II second-degree or third-degree AV block). Angina requiring anti-anginal medication. Clinically significant valvular heart disease. ECG evidence of transmural myocardial infarction. Poorly controlled hypertension (SBP >180 mmHg and/or DBP >100 mmHg);
- Contraindications to chemotherapy per investigator's assessment due to severe uncontrolled comorbidities;
- Known hypersensitivity to protocol drug components;
- History of immunodeficiency disorders (including HIV positivity), other acquired/congenital immune deficiencies, or organ transplantation;
- Any concurrent condition that in the investigator's judgment would jeopardize patient safety or compromise study completion, or other grounds for ineligibility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Efficacy of TQB2102 and TCbHP in Neoadjuvant Treatment for HER2-positive Early Breast Cancer: A Randomized Phase II Clinical Trial.
The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Patients will undergo definitive surgery (breast conservation or mastectomy with sentinel lymph-node evaluation or axillary dissection) 3 to 6 weeks after the last cycle of the neoadjuvant phase. Primary endpoint is pathological complete response, defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery.
- Conditions
- Breast Cancer, HER2 + Breast Cancer
- Being tested
- TQB2102, Docetaxel + Carboplatin + Trastuzumab +Pertuzumab
- Keywords
- HER2 positive, neoadjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102Drug
TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.
Docetaxel + Carboplatin + Trastuzumab +PertuzumabDrug
Docetaxel 75 mg/m2(day 1) , Carboplatin (AUC=6) (day 1), Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Pertuzumab (840mg first dose, 420mg/kg sequential) are administered intravenously every 3 weeks for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 group | Experimental | TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles. Receives: Drug: TQB2102 |
| TCbHP | Active comparator | Docetaxel + carboplatin + trastuzumab + pertuzumab (every 3 weeks) Receives: Drug: Docetaxel + Carboplatin + Trastuzumab +Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
pCR was defined as ypT0/Tis ypN0 at surgery
Measured: up to 180 days
Secondary outcomes (4)
Event-Free Survival (EFS)
EFS was defined as time from randomization to invasive progression (local/distant), recurrence, or death.
Measured: 5-10 years
Adverse Event (AE)
Measured: up to 180 days
Overall Survival (OS)
OS was measured from randomization to death from any cause. Patients without documented death were censored at the last contact date.
Measured: 5-10 years
Objective Response Rate （ORR）
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 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 Henan Cancer HospitalThe 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136974
- Sponsor's protocol ID
- HELEN-025
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of TQB2102 and TCbHP in Neoadjuvant Treatment for HER2-positive Early Breast Cancer: A Randomized Phase II Clinical Trial.
- ClinicalTrials.gov ID
- NCT07136974
- Acronym / sponsor ID
- HELEN-025
- Conditions
- Breast Cancer, HER2 + Breast Cancer
- Keywords
- HER2 positive, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 22 Aug 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.
The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Patients will undergo definitive surgery (breast conservation or mastectomy with sentinel lymph-node evaluation or axillary dissection) 3 to 6 weeks after the last cycle of the neoadjuvant phase. Primary endpoint is pathological complete response, defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2102 group | Experimental | Drug: TQB2102TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles. |
| TCbHP | Active comparator | Drug: Docetaxel + Carboplatin + Trastuzumab +PertuzumabDocetaxel + carboplatin + trastuzumab + pertuzumab (every 3 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 years,
- ECOG performance status 0-1;
- Clinical T2-T4, or T1c with axillary lymph node metastasis; Confirmed HER2-positive status (per 2018 ASCO/CAP HER2 Testing Guidelines, defined as IHC 3+ or FISH positive);
- Clinically measurable lesion: Lesion measurable by ultrasound, mammography, or optional MRI within 1 month before randomization;
- No chemotherapy contraindications based on organ and bone marrow function tests within 1 month prior to chemotherapy: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, Hemoglobin ≥90 g/L, Platelet count ≥100×10⁹/L, Total bilirubin <1.5 × ULN (upper limit of normal), Creatinine <1.5 × ULN, AST/ALT <1.5 × ULN, Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;
Key exclusion criteria (8 listed)
- Stage IV (metastatic) breast cancer;
- Prior treatments received including chemotherapy, endocrine therapy, targeted therapy, or radiotherapy; History of other malignancies within 3 years or concurrent malignancies. Exceptions: Other malignancies treated with surgery alone achieving ≥5-year disease-free survival (DFS) . Cured cervical carcinoma in situ or non-melanoma skin cancer;
- Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or incomplete recovery from such procedures;
- Significant cardiac disease or conditions including but not limited to: History of heart failure or systolic dysfunction (LVEF <50%). Uncontrolled high-risk arrhythmias: Atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (Mobitz II second-degree or third-degree AV block). Angina requiring anti-anginal medication. Clinically significant valvular heart disease. ECG evidence of transmural myocardial infarction. Poorly controlled hypertension (SBP >180 mmHg and/or DBP >100 mmHg);
- Contraindications to chemotherapy per investigator's assessment due to severe uncontrolled comorbidities;
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 |
|---|---|---|
| TQB2102TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles. | Drug | TQB2102 group |
| Docetaxel + Carboplatin + Trastuzumab +PertuzumabDocetaxel 75 mg/m2(day 1) , Carboplatin (AUC=6) (day 1), Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Pertuzumab (840mg first dose, 420mg/kg sequential) are administered intravenously every 3 weeks for 6 cycles. | Drug | TCbHP |
Primary outcome
Pathological Complete Response (pCR)
Time frame: up to 180 days
pCR was defined as ypT0/Tis ypN0 at surgery
4 secondary outcomes
Event-Free Survival (EFS)
Time frame: 5-10 years
Adverse Event (AE)
Time frame: up to 180 days
Overall Survival (OS)
Time frame: 5-10 years
Objective Response Rate （ORR）
Time frame: up to 180 days
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 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB2102 and Docetaxel + Carboplatin + Trastuzumab +Pertuzumab in people with Breast Cancer and HER2 + Breast Cancer, run by Henan Cancer Hospital at 1 site 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 8 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: opening soon, as of the sponsor's last update on 22 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 1 site 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?
Contact Zhenzhen Liu (13603862755, zlyyliuzhenzhen0800@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: up to 180 days). 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 22 Aug 2025.