Breast CancerPhase 2NCT06967103
QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
A Phase 2 study testing QL1706 and Nab-PE in people with Breast Cancer and HR+/HER2- Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are: Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HR+/HER2- Breast Cancer
- What is being tested?
- QL1706 and Nab-PE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2025to 30 May 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria are eligible for inclusion in this study:
- Voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.
- Female, aged ≥18 years .
- Evaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.
- cT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Histologically and/or cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor [ER] or progesterone receptor [PR] nuclear staining >1%) with Ki67 ≥20%.
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- HER2-negative breast cancer, defined as:
- Negative in situ hybridization (ISH) results; or
- Immunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative.
- Willing to provide fresh or archived tumor tissue samples.
- At least one measurable lesion per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate organ function, defined as:
- Hematology:
- Hemoglobin ≥90 g/L
- Absolute neutrophil count ≥1.5 × 10⁹/L
- Platelet count ≥100 × 10⁹/L.
- Biochemistry:
- ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present);
- Total bilirubin ≤1.5 × ULN;
- Serum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min.
- Coagulation:
- Activated partial thromboplastin time (APTT) ≤1.5 × ULN;
- International normalized ratio (INR) ≤1.5 × ULN.
- Cardiac function:
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiography.
- Premenopausal or perimenopausal subjects must agree to use reliable and effective contraception or practice abstinence from the time of informed consent until at least 90 days after the last dose of study treatment.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from this study:
- Known severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients.
- Stage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator.
- Inflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma).
- Major surgery or significant trauma within 28 days prior to the first dose.
- Administration of live attenuated vaccines within 28 days before the first dose or anticipated during the study.
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- Systemic corticosteroids or immunosuppressive therapy within 14 days prior to the first dose or anticipated during the study.
- Active autoimmune disease requiring systemic treatment within 2 years prior to enrollment, or history of autoimmune disorders.
- Severe systemic infection within 28 days or active infection requiring intravenous/oral antibiotics within 14 days prior to the first dose.
- Prior organ or allogeneic bone marrow transplantation or awaiting transplantation.
- History or evidence of interstitial lung disease or active non-infectious pneumonitis.
- Bleeding tendency or high risk of hemorrhage.
- Thromboembolic events (e.g., cerebrovascular accident, pulmonary embolism) within 6 months prior to enrollment.
- Congenital or acquired immunodeficiency (e.g., HIV infection).
- Active hepatitis:
- Hepatitis B: HBsAg-positive with HBV DNA ≥2000 IU/mL;
- Hepatitis C: HCV antibody-positive with HCV RNA above the upper limit of normal.
- Poorly controlled cardiac conditions, including:
- NYHA Class II or higher heart failure or LVEF <50%;
- Unstable angina;
- Myocardial infarction within 1 year;
- QTc interval >470 ms (female) on resting ECG.
- Other malignancies within 5 years (excluding basal cell carcinoma or cervical carcinoma in situ).
- Use of investigational drugs within 4 weeks prior to the first dose.
- History or current diagnosis of neurological or psychiatric disorders (e.g., epilepsy, dementia).
- History of pancreatitis.
- Pregnancy, lactation, or refusal to use contraception.
- Any other condition deemed inappropriate for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou
Jing Ding, 13939001423
About this study
Official title: QL1706 Combined With PE Compared With PE for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are:
Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.
- Conditions
- Breast Cancer, HR+/HER2- Breast Cancer
- Being tested
- QL1706, Nab-PE
- Keywords
- PD1, CTLA4, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
bispecific antibody targeting PD-1 and CLTA-4
Nab-PEDrug
Nab-paclitaxel+Epirubicin
| Study group | Role | What they receive |
|---|---|---|
| QL1706 group | Experimental | NabPE+QL1706 every 3 weeks for 6 cycles. Then participants will receive surgery and QL1706 will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment. Receives: Drug: QL1706; Drug: Nab-PE |
| NabPE group | Active comparator | NabPEevery 3 weeks for 6 cycles. Then participants will receive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Measured: up to 24 weeks
pathological complete response in PDL1 positive subgroup
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
Measured: up to 24 weeks
Secondary outcomes (3)
Event-Free Survival (EFS)
Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Measured: 5-10 years
Objective Response Rate (ORR)
ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)
Measured: up to 24 weeks
adverse events
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start8 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 May 2029 (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
- 238 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
- NCT06967103
- Sponsor's protocol ID
- HELEN-024
- Status last verified
- Jan 2026
- First submitted
- 30 Apr 2025
- Last updated
- 8 Jan 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QL1706 Combined With PE Compared With PE for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT06967103
- Acronym / sponsor ID
- HELEN-024
- Conditions
- Breast Cancer, HR+/HER2- Breast Cancer
- Keywords
- PD1, CTLA4, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 13 May 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 goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are:
Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706 group | Experimental | Drug: QL1706, Drug: Nab-PENabPE+QL1706 every 3 weeks for 6 cycles. Then participants will receive surgery and QL1706 will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment. |
| NabPE group | Active comparator | –NabPEevery 3 weeks for 6 cycles. Then participants will receive surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.
- Female, aged ≥18 years .
- Evaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.
- cT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Histologically and/or cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor [ER] or progesterone receptor [PR] nuclear staining >1%) with Ki67 ≥20%.
Key exclusion criteria (28 listed)
- Known severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients.
- Stage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator.
- Inflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma).
- Major surgery or significant trauma within 28 days prior to the first dose.
- Administration of live attenuated vaccines within 28 days before the first dose or anticipated during the study.
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 |
|---|---|---|
| QL1706bispecific antibody targeting PD-1 and CLTA-4 | Drug | QL1706 group |
| Nab-PENab-paclitaxel+Epirubicin | Drug | QL1706 group |
Primary outcome
pathological complete response
Time frame: up to 24 weeks
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
pathological complete response in PDL1 positive subgroup
Time frame: up to 24 weeks
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
3 secondary outcomes
Event-Free Survival (EFS)
Time frame: 5-10 years
Objective Response Rate (ORR)
Time frame: up to 24 weeks
adverse events
Time frame: up to 24 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 8 Jan 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.
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 QL1706 and Nab-PE in people with Breast Cancer and HR+/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 27 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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 (time frame: up to 24 weeks). 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 8 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.