Breast CancerPhase 2NCT07246317
Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or Locally Advanced HER2+ Breast Cancer
A Phase 2 study testing QL1706 injection, Trastuzumab (or biosimilar) and Pertuzumab (or biosimilar) in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 8 sites in China.
Trial summary
This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- QL1706 injection, Trastuzumab (or biosimilar) and Pertuzumab (or biosimilar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 8 sitesChina
- Study dates
- 15 Dec 2025to 31 Dec 2032
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent and compliant.
- Age 18-70 years.
- ECOG PS 0-1; life expectancy >6 months.
- Histologically/cytologically confirmed primary breast cancer.
- Primary tumor >2cm (by local standard assessment) or node-positive disease.
- AJCC 8th edition Stage II-IIIC (T2-T4 any N, or any T N1-3 M0) unilateral invasive breast cancer.
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- Confirmed HER2-positive (IHC 3+ or ISH positive). Note: Patients with HER2-negative primary tumor but HER2-positive nodes are eligible.
- At least one measurable lesion per RECIST 1.1.
- Agreement to undergo surgery if indicated after neoadjuvant therapy.
- Willing to provide tumor tissue for biomarker analysis.
- Adequate organ function:
- ANC ≥1.5×10⁹/L; PLT ≥100×10⁹/L; HGB ≥90 g/L
- Albumin ≥30 g/L
- -. TBIL ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases); AKP ≤2.5×ULN
- Creatinine ≤1.5×ULN
- PT/APTT/INR ≤1.5×ULN (or within therapeutic range if on anticoagulants)
- For women of childbearing potential: negative pregnancy test within 7 days prior to treatment; must not be breastfeeding.
- Use of highly effective contraception during and for 3 months after treatment.
Who cannot join
- Stage IV metastatic breast cancer or patients deemed ineligible for curative surgery after neoadjuvant therapy.
- Inflammatory breast cancer.
- Other malignancies within 3 years, except: those treated with surgery alone and disease-free for 5 years; cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder cancer [Ta, Tis, T1].
- Prior anti-tumor therapy (chemotherapy, endocrine, anti-HER2) or breast surgery for breast cancer within 3 years (excluding diagnostic biopsy).
- Major surgery or significant traumatic injury within 28 days before treatment (excluding diagnostic biopsy).
- Active or history of autoimmune diseases (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Exceptions: vitiligo, childhood asthma in complete remission without intervention in adulthood.
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- Current use of immunosuppressants or systemic corticosteroids (>10mg/day prednisone equivalent) within 2 weeks prior to enrollment.
- History of severe hypersensitivity to monoclonal antibodies.
- Known central nervous system metastases.
- Poorly controlled concurrent illnesses, including:
- Uncontrolled hypertension (SBP>150 or DBP>100 mmHg on medication) or history of hypertensive crisis/encephalopathy.
- History of heart failure or systolic dysfunction (LVEF <55%).
- Myocardial ischemia/infarction (≥Grade 2), arrhythmias (QTc≥450ms M, ≥470ms F), or CHF (≥NYHA Class II).
- Angina requiring medication; clinically significant valvular disease.
- Active HCV (RNA+), HIV+, syphilis (unless cured), or HBV (HBsAg+ with HBV DNA≥2000 IU/ml or positive qualitative test).
- Use of Chinese patent medicines with approved anti-tumor indications within 2 weeks prior to treatment.
- Significant bleeding tendency or clinical bleeding within 3 months; positive fecal occult blood requiring gastroscopy if persistently positive.
- Tumor invasion or high risk of invasion into major vessels, potentially causing fatal hemorrhage.
- Pleural, peritoneal, or pericardial effusion requiring drainage (eligible if stable after drainage).
- Arterial/venous thromboembolic events within 6 months (e.g., CVA, TIA, DVT, PE).
- Known hereditary or acquired bleeding/thrombotic tendencies (e.g., hemophilia).
- Severe, non-healing wounds, active ulcers, or untreated fractures.
- Urinary protein ≥++ confirmed by 24-hour urine protein >1.0g.
- Active infection, unexplained fever ≥38.5°C within 7 days, or baseline WBC >15×10⁹/L.
- History of drug abuse or psychiatric disorders.
- Participation in other anti-tumor drug trials within 4 weeks.
- Allergy to any study drug or its components.
- Any condition deemed by the investigator to pose a safety risk or affect study completion.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
The West China Second University Hospital of Sichuan University (WCSUH- SCU)
Chengdu, Sichuan
Rutie Yin, 86+18180609015, hxyrtgcp@126.com
Rutie Yin
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Kun Wang, 86+13922118086, gzwangkun@126.com
Kun Wang
The First Affiliated Hospital, Sun Yat-sen University (FAH-SYSU)
Guangzhou, Guangdong
Ying Lin, 86+13076873871, frostlin@hotmail.com
Ying Lin
Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang
Caiping Chen, 86+13967370819, luyun6@163.com
Caiping Chen
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Limin Wei, 86+13783100995, 13783100995@163.com
Limin Wei
Nanyang Central Hospital
Nanyang, Henan
Zheng Wang, 86+13723010881, 20090957@qq.com
Hao Zhang
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Cuizhi Geng, 86+18435221693, cuizhi_geng@163.com
Cuizhi Geng
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Jin Zhang, +8618622221173, zhangjintjmuch1@163.com
Jin Zhang
About this study
Official title: A Multicenter, Prospective, Randomized Phase II Trial Evaluating Trastuzumab, Pertuzumab, Docetaxel Combined With QL1706 Versus Combined With Carboplatin as Neoadjuvant Therapy for Early or Locally Advanced HER2+ Breast Cancer
This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.
Read the detailed description
This multicenter, randomized phase II trial evaluates the efficacy and safety of neoadjuvant therapy with trastuzumab, pertuzumab, and docetaxel plus QL1706 versus the same regimen plus carboplatin in patients with operable or locally advanced HER2-positive breast cancer.
The study will enroll 188 subjects, randomly assigned 1:1 to either the QL1706 combination arm or the carboplatin combination arm, stratified by nodal status and hormone receptor status (<10% vs ≥10%). Both treatment groups will receive four 3-week cycles of assigned therapy followed by surgical resection and response assessment. Postoperative adjuvant treatment will be administered according to investigator discretion and guideline recommendations.
- Conditions
- Breast Cancer
- Being tested
- QL1706 injection, Trastuzumab (or biosimilar), Pertuzumab (or biosimilar), Docetaxel, Carboplatin
- Keywords
- QL1706, HER2+, breast cancer, neoadjuvant therapy, Pertuzumab, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 injectionDrug
On Day 1 of each cycle at a dose of 5 mg/kg, IV infusion
Trastuzumab (or biosimilar)Drug
On Day 1 of each cycle; 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks
Pertuzumab (or biosimilar)Drug
On Day 1 of each cycle; 840 mg IV loading dose followed by 420 mg IV every 3 weeks
DocetaxelDrug
On Day 1 of each cycle at a dose of 75 mg/m², IV infusion
CarboplatinDrug
On Day 1 of each cycle at a dose of AUC = 4, IV infusion
| Study group | Role | What they receive |
|---|---|---|
| QL1706 arm | Experimental | Trastuzumab, pertuzumab, docetaxel combined with QL1706, q3w, for a total of 4 cycles Receives: Drug: QL1706 injection; Drug: Trastuzumab (or biosimilar); Drug: Pertuzumab (or biosimilar); Drug: Docetaxel |
| Standard therapy arm | Active comparator | Trastuzumab, pertuzumab, docetaxel combined with carboplatin, q3w, for a total of 4 cycles Receives: Drug: Trastuzumab (or biosimilar); Drug: Pertuzumab (or biosimilar); Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Measured: Up to approximately 16-18weeks
Secondary outcomes (7)
pCR rate using the definition of ypT0/Tis (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery
Measured: Up to approximately 16-18 weeks
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
ORR is defined as the percentage of participants in the analysis population who achieve confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Measured: Up to approximately 12 weeks
Event Free Survival
EFS is defined as the time from randomization to any of the following events: preoperative disease progression as determined by the investigator according to RECIST v1.1 - any evidence of contralateral in situ disease is not considered disease progression (PD), while all evidence of contralateral invasive disease is considered PD; postoperative disease recurrence (local, regional, distant, or contralateral); death from any cause. (Whichever occurs first)
Measured: Up to approximately 5 years
Disease-free Survival
DFS is defined as the time from date of surgery (date of no disease) to the first documentation of progressive disease (local, regional, distant, or contralateral) or death.
Measured: Up to approximately 5 years
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 5 years
Breast-conserving surgery rate
Breast-conserving surgery rate is the proportion of patients who underwent breast-conserving surgery among all patients who underwent surgery.
Measured: Up to approximately 16-18 weeks
Radical resection rate
The proportion of patients who achieved radical resection among all patients.
Measured: Up to approximately 16-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (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 Tianjin Medical University Cancer Institute and 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
- 188 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246317
- Sponsor's protocol ID
- QL-BC-QIBA-1005
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Phase II Trial Evaluating Trastuzumab, Pertuzumab, Docetaxel Combined With QL1706 Versus Combined With Carboplatin as Neoadjuvant Therapy for Early or Locally Advanced HER2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT07246317
- Acronym / sponsor ID
- QL-BC-QIBA-1005
- Conditions
- Breast Cancer
- Keywords
- QL1706, HER2+, breast cancer, neoadjuvant therapy, Pertuzumab, Trastuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 24 Nov 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 study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.
Detailed description
This multicenter, randomized phase II trial evaluates the efficacy and safety of neoadjuvant therapy with trastuzumab, pertuzumab, and docetaxel plus QL1706 versus the same regimen plus carboplatin in patients with operable or locally advanced HER2-positive breast cancer.
The study will enroll 188 subjects, randomly assigned 1:1 to either the QL1706 combination arm or the carboplatin combination arm, stratified by nodal status and hormone receptor status (<10% vs ≥10%). Both treatment groups will receive four 3-week cycles of assigned therapy followed by surgical resection and response assessment. Postoperative adjuvant treatment will be administered according to investigator discretion and guideline recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706 arm | Experimental | Drug: QL1706 injection, Drug: Trastuzumab (or biosimilar), Drug: Pertuzumab (or biosimilar), Drug: DocetaxelTrastuzumab, pertuzumab, docetaxel combined with QL1706, q3w, for a total of 4 cycles |
| Standard therapy arm | Active comparator | Drug: Trastuzumab (or biosimilar), Drug: Pertuzumab (or biosimilar), Drug: Docetaxel, Drug: CarboplatinTrastuzumab, pertuzumab, docetaxel combined with carboplatin, q3w, for a total of 4 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent and compliant.
- Age 18-70 years.
- ECOG PS 0-1; life expectancy >6 months.
- Histologically/cytologically confirmed primary breast cancer.
- Primary tumor >2cm (by local standard assessment) or node-positive disease.
Key exclusion criteria (28 listed)
- Stage IV metastatic breast cancer or patients deemed ineligible for curative surgery after neoadjuvant therapy.
- Inflammatory breast cancer.
- Other malignancies within 3 years, except: those treated with surgery alone and disease-free for 5 years; cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder cancer [Ta, Tis, T1].
- Prior anti-tumor therapy (chemotherapy, endocrine, anti-HER2) or breast surgery for breast cancer within 3 years (excluding diagnostic biopsy).
- Major surgery or significant traumatic injury within 28 days before treatment (excluding diagnostic biopsy).
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 |
|---|---|---|
| QL1706 injectionOn Day 1 of each cycle at a dose of 5 mg/kg, IV infusion | Drug | QL1706 arm |
| Trastuzumab (or biosimilar)On Day 1 of each cycle; 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks | Drug | QL1706 arm, Standard therapy arm |
| Pertuzumab (or biosimilar)On Day 1 of each cycle; 840 mg IV loading dose followed by 420 mg IV every 3 weeks | Drug | QL1706 arm, Standard therapy arm |
| DocetaxelOn Day 1 of each cycle at a dose of 75 mg/m², IV infusion | Drug | QL1706 arm, Standard therapy arm |
| CarboplatinOn Day 1 of each cycle at a dose of AUC = 4, IV infusion | Drug | Standard therapy arm |
Primary outcome
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Time frame: Up to approximately 16-18weeks
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
7 secondary outcomes
pCR rate using the definition of ypT0/Tis (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Time frame: Up to approximately 16-18 weeks
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Time frame: Up to approximately 12 weeks
Event Free Survival
Time frame: Up to approximately 5 years
Disease-free Survival
Time frame: Up to approximately 5 years
Overall survival (OS)
Time frame: Up to approximately 5 years
Breast-conserving surgery rate
Time frame: Up to approximately 16-18 weeks
Radical resection rate
Time frame: Up to approximately 16-18 weeks
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 28 Nov 2025.
- Individual participant dataSharing planned: No
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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.
8 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 QL1706 injection, Trastuzumab (or biosimilar) and Pertuzumab (or biosimilar) in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 8 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 18 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: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Contact Jin Zhang (+8618622221173, zhangjintjmuch1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (time frame: Up to approximately 16-18weeks). 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 28 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.