Breast CancerPhase 2NCT07372079
Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy
A Phase 2 study testing QL1706 combined with Chemotherapy in people with Breast Cancer and Neoadjuvant Therapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Therapy, Immune Checkpoint Inhibitors
- What is being tested?
- QL1706 combined with Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2026to 30 Dec 2029
- Phase
- Phase 2
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily join this study, sign the informed consent form, and demonstrate good compliance;
- Age: 18-75 years old (at the time of signing the informed consent form);
- ECOG PS score: 0-1; expected survival time exceeding 6 months;
- Patients with primary breast cancer confirmed by histopathological or cytological examination;
- Primary tumor diameter > 2 cm as measured by local standard assessment methods;
- Judged by the investigator to meet the American Joint Committee on Cancer (AJCC) 8th edition breast cancer TNM staging criteria as cT2-cT4, cN0-cN3, cM0, with locally advanced or early-stage, unilateral, and histologically confirmed invasive breast cancer;
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- According to the latest ASCO/CAP guideline definitions, histopathologically confirmed early-stage triple-negative invasive breast carcinoma meeting all of the following criteria:Tumors are triple-negative on pathological subtyping, defined as: ER-negative: IHC ≤10%; PR-negative: IHC ≤10%; HER2-negative: IHC 0/1+, or IHC 2+ with negative ISH.
- At least one measurable lesion according to RECIST 1.1;
- The patient agrees to undergo breast cancer resection surgery when meeting the surgical criteria after neoadjuvant therapy;
- PD-L1 expression status is known;
- Major organ functions are in good condition;
- Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use acceptable and effective contraception from screening onward and agree to continue these precautions until 12 months after the last dose of the study drug; periodic abstinence and rhythm methods are not acceptable contraceptive methods.
- The subject is willing to provide core needle biopsy tissue samples for research analysis.
Who cannot join
- Patients with stage IV metastatic breast cancer or other patients deemed by the investigator as unable to achieve curative surgical resection through neoadjuvant therapy;
- Patients with inflammatory breast cancer;
- Patients who have had or currently have other malignancies within the past 3 years. The following two conditions may be eligible: other malignancies treated with a single surgical procedure, achieving continuous 5-year disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)];
- Breast cancer patients who have received antitumor therapies such as chemotherapy, endocrine therapy, or immune checkpoint inhibitors within the past 3 years, or who have undergone breast surgery (except diagnostic biopsy for primary breast cancer);
- Patients who have undergone major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (except diagnostic biopsy for primary breast cancer);
- Presence of any active autoimmune disease or a history of autoimmune disease;
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- Patients currently using immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (at a dose >10 mg/day prednisone or equivalent steroids) and continuing such treatment within 2 weeks prior to enrollment;
- Allergy to any study drug or any component or excipient of the drug;
- Patients with concomitant diseases judged by the investigator as seriously endangering the subject's safety or affecting study completion, or those deemed unsuitable for enrollment for other reasons.
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
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Yongsheng Jia, Doctor, +86 18622199359, yongshengjia@tjmuch.com
Jun Zhang, doctor, doctorjunzhang@163.com
About this study
Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). This is a prospective clinical study that plans to enroll screened, eligible early-stage breast-cancer patients to receive neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive four additional AC cycles before surgery. A key feature is the incorporation of an response-guided neoadjuvant therapy（RGN）model to identify sensitive patients who can forgo anthracyclines, thereby reducing long-term cardiotoxicity.
- Being tested
- QL1706 combined with Chemotherapy
- 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 combined with ChemotherapyDrug
Participants receive QL1706 every 3 weeks (Q3W) + Albumin-bound paclitaxel every 3 weeks (Q3W) + Cisplatin (Q3W) x 4 cycles. After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive QL1706 Q3W + epirubicin Q3W + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy before surgery.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 Combination Therapy | Experimental | neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). Receives: Drug: QL1706 combined with Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR（ypT0/is ypN0）
Measured: Up to approximately 27-30 weeks
Secondary outcomes (6)
Radiologic complete response rate (iCR)
Measured: Up to approximately 27-30 weeks
epirubicin-cyclophosphamide regimen utilization rate
Measured: Up to approximately 16 weeks
Event-free Survival (EFS) as assessed by Investigator
Measured: Up to approximately 8 years
Percentage of participants who experience an adverse event (AE)
Measured: Up to approximately 60 weeks
Overall survival (OS)
Measured: Up to approximately 8 years
Health-Related Quality of Life (HR-QoL) score
Measured: Up to approximately 27-30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start14 Apr 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongsheng Jia, Study chair, Tianjin Medical University Cancer Institute and HospitalJun Zhang, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372079
- Sponsor's protocol ID
- E20251311
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No