HR-positive/HER2-negative Breast CancerPhase 2NEO-ITHRANNCT07396324
Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab, Paclitaxel and Carboplatin in people with HR-positive/HER2-negative Breast Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR-positive/HER2-negative Breast Cancer
- What is being tested?
- Iparomlimab and Tuvonralimab, Paclitaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to Dec 2031
- 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
- Aged ≥18 years
- Histologically confirmed hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer
- Subjects with at least one evaluable lesion
- ECOG 0-1
- Adequate organ function
Who cannot join
- Metastatic disease (Stage IV)
- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
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
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Wenjin Yin, 86(21)68385569, yinwenjin@renji.com
About this study
Official title: NEOadjuvant Iparomlimab and Tuvonralimab (QL1706) Plus Chemotherapy in Patients With Hormone Receptor Positive And HER2-Negative Breast Cancer: a Prospective, Single Arm, Multicenter Clinical Trial
This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
- Conditions
- HR-positive/HER2-negative Breast Cancer
- Being tested
- Iparomlimab and Tuvonralimab, Paclitaxel, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and TuvonralimabDrug
Also called QL1706
5.0mg/kg qw, start from C1D15
PaclitaxelDrug
Also called PTX
80mg/m^2 qw
CarboplatinDrug
Also called CBP
AUC=1.5, D1, 8, 15, every 28 days
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant Iparomlimab and Tuvonralimab (QL1706) | Experimental | Iparomlimab and Tuvonralimab (QL1706) in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy Receives: Drug: Iparomlimab and Tuvonralimab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with pCR
Number of patients with pathological complete response/Number of all eligible patients
Measured: 1-2 weeks after surgery
Secondary outcomes (1)
Proportion of patients with adverse events
Number of patients with adverse events during neoadjuvant therapy assessed according to the NCI CTCAE v5.0/Number of all eligible patients
Measured: From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR-positive/HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Wenjin Yin, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396324
- Sponsor's protocol ID
- LY2025-422-A
- Acronym
- NEO-ITHRAN
- Status last verified
- May 2026
- First submitted
- 1 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, SAP and ICF are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOadjuvant Iparomlimab and Tuvonralimab (QL1706) Plus Chemotherapy in Patients With Hormone Receptor Positive And HER2-Negative Breast Cancer: a Prospective, Single Arm, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07396324
- Acronym / sponsor ID
- NEO-ITHRAN / LY2025-422-A
- Conditions
- HR-positive/HER2-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 9 Feb 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 an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant Iparomlimab and Tuvonralimab (QL1706) | Experimental | Drug: Iparomlimab and Tuvonralimab, Drug: Paclitaxel, Drug: CarboplatinIparomlimab and Tuvonralimab (QL1706) in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Histologically confirmed hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer
- Subjects with at least one evaluable lesion
- ECOG 0-1
- Adequate organ function
Key exclusion criteria (2 listed)
- Metastatic disease (Stage IV)
- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
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 |
|---|---|---|
| Iparomlimab and TuvonralimabAlso: QL17065.0mg/kg qw, start from C1D15 | Drug | neoadjuvant Iparomlimab and Tuvonralimab (QL1706) |
| PaclitaxelAlso: PTX80mg/m^2 qw | Drug | neoadjuvant Iparomlimab and Tuvonralimab (QL1706) |
| CarboplatinAlso: CBPAUC=1.5, D1, 8, 15, every 28 days | Drug | neoadjuvant Iparomlimab and Tuvonralimab (QL1706) |
Primary outcome
Proportion of patients with pCR
Time frame: 1-2 weeks after surgery
Number of patients with pathological complete response/Number of all eligible patients
1 secondary outcome
Proportion of patients with adverse events
Time frame: From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)
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 13 May 2026.
- Individual participant dataSharing planned: Yes. Study protocol, SAP and ICF are to be shared with other researchers.
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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.
Wenjin Yin principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
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 Iparomlimab and Tuvonralimab, Paclitaxel and Carboplatin in people with HR-positive/HER2-negative Breast Cancer, run by RenJi 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 5 inclusion and 2 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 13 May 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 Wenjin Yin (86(21)68385569, yinwenjin@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with pCR (time frame: 1-2 weeks after surgery). 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 13 May 2026.