Triple Negative Breast Cancer (TNBC)Phase 2NCT07342283
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
A Phase 2 study testing Immunotherapy combined with chemotherapy in people with Triple Negative Breast Cancer (TNBC), run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Immunotherapy combined with chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2026to 25 Dec 2028
- 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
- Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score <3 or <1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;
- Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
- Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
- Treatment-naïve subjects;
- Age ≥18 years, both genders eligible;
- ECOG performance status 0-1;
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- Adequate bone marrow, cardiac, and organ function;
- Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;
- Ability to comprehend and provide written informed consent.
Who cannot join
- History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
- Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
- Stage IV metastatic breast cancer;
- Administration of a vaccine within 30 days before the first dose of the study treatment;
- Subjects with severe systemic diseases;
- Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
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- Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;
- Lactating women should discontinue breastfeeding during the study;
- Subjects with known allergies to the study drug or any of its excipients;
- Any other condition deemed inappropriate for participation in the study by the investigator.
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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
Affiliated Hospital of Nantong University
Nantong, Jiangsu
0513 8505 2222
About this study
This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Being tested
- Immunotherapy combined with chemotherapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy combined with chemotherapyDrug
Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | QL1706 plus carboplatin and albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 plus doxorubicin/epirubicin and cyclophosphamide (21-day cycles for 4 cycles) Receives: Drug: Immunotherapy combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR) rates
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 9 months
Secondary outcomes (4)
Objective response rate（ORR）
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1
Measured: Up to approximately 27-30 weeks
3y-EFS
Percentage of patients who, from the initiation of treatment, remain free of any of the following events within three years: disease progression to unresectable status, local or distant recurrence, development of a second primary malignancy (breast cancer or other cancers), or death from any cause.
Measured: Up to approximately 3 years
Overall survival (OS)
OS is defined as the time from the initiation of treatment to death due to any cause. Participants without documented death at the time of the analysis will be censored at the date of the last follow-up.
Measured: Up to approximately 8 years
Adverse events
AEs will be assessed according to NCI CTCAE v5.0, by grade
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start25 Feb 2026
- Primary completion25 Dec 2027 (estimated)
- Study completion25 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342283
- Sponsor's protocol ID
- 2025-K223-02
- Status last verified
- Dec 2025
- First submitted
- 8 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07342283
- Acronym / sponsor ID
- 2025-K223-02
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 15 Jan 2026 (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 is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Immunotherapy combined with chemotherapyQL1706 plus carboplatin and albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 plus doxorubicin/epirubicin and cyclophosphamide (21-day cycles for 4 cycles) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score <3 or <1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;
- Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
- Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
- Treatment-naïve subjects;
- Age ≥18 years, both genders eligible;
Key exclusion criteria (11 listed)
- History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
- Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
- Stage IV metastatic breast cancer;
- Administration of a vaccine within 30 days before the first dose of the study treatment;
- Subjects with severe systemic diseases;
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 |
|---|---|---|
| Immunotherapy combined with chemotherapyAlbumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle. | Drug | experimental group |
Primary outcome
Pathologic complete response (pCR) rates
Time frame: Up to approximately 9 months
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.
4 secondary outcomes
Objective response rate（ORR）
Time frame: Up to approximately 27-30 weeks
3y-EFS
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 8 years
Adverse events
Time frame: up to 18 months
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 2 Mar 2026.
- 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.
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 Immunotherapy combined with chemotherapy in people with Triple Negative Breast Cancer (TNBC), run by Affiliated Hospital of Nantong University 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 9 inclusion and 11 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 2 Mar 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 Liu Fan (86+18912250939, lflove2009@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (pCR) rates (time frame: Up to approximately 9 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 2 Mar 2026.