Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination DeficiencyPhase 2NCT07113964
QL1706 With Olaparib for Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)
A Phase 2 study testing QL1706 + olaparib in people with Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study will evaluate the safety and efficacy of QL1706 and Olaparib in human epidermal growth factor receptor 2 (HER2)-negative unresectable and/or metastatic breast cancer who had received 2-4 line of prior systematic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency
- What is being tested?
- QL1706 + olaparib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 30 Mar 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75 years; Eastern Cooperative Oncology Group (ECOG) score status 0-1.
- Pathologically documented HER2-negative locally advanced or metastatic breast cancer (IHC0, IHC 1+\& IHC 2+/ISH-) that was hormone-receptor positive (i.e., estrogen-receptor positive, progesterone-receptor positive, or both) or was triple negative.
- Has been treated with 2-4 previous therapy regimens for metastatic disease.
- HRD positive confirmed, known germline and/or systemic BRCA mutation status that is predicted to be deleterious or suspected deleterious allow preferential enrolment.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.
- Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
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- A life expectancy of at least 12 weeks.
- Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 3 months. Negative serum or urine pregnancy test within 7 days before study enrollment, and must be a non-lactating subject.
- Volunteer to participate in this study and sign the informed consent.
Who cannot join
- Has any active autoimmune disease, which may worsen when receiving immune stimulants.
- Prior treatment with immune checkpoint inhibitors (ICI) (anti-CTLA-4, anti-PD-1, anti-PD-L1, combined therapy anti-PD-1/PD-L1 with anti-CTLA-4) or olaparib for advanced disease.
- Has unresolved toxicities from previous anticancer therapy.
- Has uncontrolled or significant cardiovascular disease.
- Discontinuation of prior anti-PD-1/PD-L1/CTLA-4 therapy due to immune-related toxicity.
- Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
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- Has received a live vaccine vaccination within 28 days before enrolment.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has known history of or is positive for Hepatitis B or Hepatitis C.
- Any severe or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding susceptibility or active infection, as judged by the investigator.
- Has untreated or clinically active central nervous system metastases.
- Female subjects who are pregnant, lactating or plan to become pregnant during the study.
- Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
The First Affiliated Hospital with Nanjing Medical University, 025-68307102, ymyin@njmu.edu.cn
About this study
Official title: QUEEN-OSCAR: A Prospective, Multicenter, Single-arm, Phase 2 Study of QL1706 in Combination With Olaparib in Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)
This study will evaluate the safety and efficacy of QL1706 and Olaparib in human epidermal growth factor receptor 2 (HER2)-negative unresectable and/or metastatic breast cancer who had received 2-4 line of prior systematic therapy.
- Conditions
- Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency
- Being tested
- QL1706 + olaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 + olaparibDrug
QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD1 IgG4 and anti-CTLA4 IgG1 antibodies.
Other Names: Iparomlimab and Tuvonralimab Injection Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor with biologic activity in ovarian cancer as well as other solid tumors..
Other Names: NA
| Study group | Role | What they receive |
|---|---|---|
| Experimental:QL1706 + olaparib | Experimental | Not described Receives: Drug: QL1706 + olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination DeficiencyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 79 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113964
- Sponsor's protocol ID
- QLMA-BC-IIT-002
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUEEN-OSCAR: A Prospective, Multicenter, Single-arm, Phase 2 Study of QL1706 in Combination With Olaparib in Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)
- ClinicalTrials.gov ID
- NCT07113964
- Acronym / sponsor ID
- QLMA-BC-IIT-002
- Conditions
- Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 11 Aug 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 will evaluate the safety and efficacy of QL1706 and Olaparib in human epidermal growth factor receptor 2 (HER2)-negative unresectable and/or metastatic breast cancer who had received 2-4 line of prior systematic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental:QL1706 + olaparib | Experimental | Drug: QL1706 + olaparib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 - 75 years; Eastern Cooperative Oncology Group (ECOG) score status 0-1.
- Pathologically documented HER2-negative locally advanced or metastatic breast cancer (IHC0, IHC 1+\& IHC 2+/ISH-) that was hormone-receptor positive (i.e., estrogen-receptor positive, progesterone-receptor positive, or both) or was triple negative.
- Has been treated with 2-4 previous therapy regimens for metastatic disease.
- HRD positive confirmed, known germline and/or systemic BRCA mutation status that is predicted to be deleterious or suspected deleterious allow preferential enrolment.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.
Key exclusion criteria (13 listed)
- Has any active autoimmune disease, which may worsen when receiving immune stimulants.
- Prior treatment with immune checkpoint inhibitors (ICI) (anti-CTLA-4, anti-PD-1, anti-PD-L1, combined therapy anti-PD-1/PD-L1 with anti-CTLA-4) or olaparib for advanced disease.
- Has unresolved toxicities from previous anticancer therapy.
- Has uncontrolled or significant cardiovascular disease.
- Discontinuation of prior anti-PD-1/PD-L1/CTLA-4 therapy due to immune-related toxicity.
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 + olaparibQL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD1 IgG4 and anti-CTLA4 IgG1 antibodies. Other Names: Iparomlimab and Tuvonralimab Injection Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor with biologic activity in ovarian cancer as well as other solid tumors.. Other Names: NA | Drug | Experimental:QL1706 + olaparib |
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to approximately 3 years
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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 + olaparib in people with Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency, run by The First Affiliated Hospital with Nanjing Medical 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 13 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 11 Aug 2025. 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 Yongmei Yin, MD,PhD (025-68307102, ymyin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Up to approximately 3 years). 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 11 Aug 2025.