Triple-Negative Breast Cancer (TNBC)Phase 2NCT07005583
Clinical Study of QL1706 in Combination With Olaparib for the Treatment of Patients With Previously Treated Homologous Recombination Repair-Deficient Recurrent or Metastatic Triple-Negative Breast Cancer
A Phase 2 study testing QL1706 Plus Olaparib in people with Triple-Negative Breast Cancer (TNBC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a single-arm, prospective, Phase II clinical trial designed to assess the efficacy and safety of QL1706 in combination with olaparib in patients with recurrent or metastatic triple-negative breast cancer (TNBC) harboring homologous recombination repair deficiency (HRD) who have received prior therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- QL1706 Plus Olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 20 May 2030
- 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
- Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
- Female breast cancer patients aged ≥18 and ≤75 years, with histologically or cytologically confirmed recurrent or metastatic triple-negative breast cancer (TNBC) as defined by the latest ASCO/CAP guidelines (based on the most recent biopsy or other pathological specimens).
- Have received at least 1 but no more than 2 prior lines of anti-tumor therapy （ Disease progression during or within 12 months after completing neoadjuvant/adjuvant therapy counts as one line of therapy；Must have received taxane-based therapy at any stage；A maximum of 1 prior antibody-drug conjugate (ADC) therapy is allowed.）
- Documented homologous recombination repair deficiency (HRD) (BRCA1/2 mutation and/or HRD-positive status.
- Any PD-L1 expression status (no restriction).
- Have at least one measurable lesion according to RECIST 1.1 criteria (assessed by CT or MRI). Bone-only lesions are considered non-measurable and do not qualify for enrollment.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Availability of tumor tissue samples for biomarker testing.
- Ability to swallow tablets normally.
- Expected survival ≥3 months.
- Presence of adequate bone marrow and organ function.
Who cannot join
- Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1, anti-CTLA-4) or PARP inhibitors (e.g., olaparib, niraparib).
- Current use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
- History of severe allergic reactions to monoclonal antibodies.
- 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.
- History of CNS metastases or current CNS metastases. Baseline imaging to confirm absence of brain metastases is not mandatory. Patients with unknown CNS status but clinical signs suggestive of CNS involvement are eligible if CNS metastases are ruled out by CT/MRI.
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- History of other malignancies (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless disease-free for ≥3 years.
- Uncontrolled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg) despite antihypertensive therapy. History of hypertensive crisis or hypertensive encephalopathy.
- History of unstable angina, myocardial infarction, chronic heart failure (LVEF <50%), or clinically significant arrhythmias requiring treatment (except stable atrial fibrillation) within 6 months prior to treatment.
- Current therapeutic anticoagulation or thrombolysis (prophylactic low-dose aspirin/LMWH permitted).
- Clinically significant effusions (pleural, peritoneal, or pericardial) requiring drainage, unless stabilized post-drainage per investigator assessment.
- Arterial/venous thromboembolic events (e.g., CVA, TIA, DVT, PE) within 6 months prior to enrollment.
- Major vascular disease (e.g., aortic aneurysm requiring repair or recent peripheral arterial thrombosis) within 6 months.
- Major surgery within 4 weeks prior to treatment or anticipated during the study (excluding diagnostic procedures).
- Urine protein ≥++ on dipstick with confirmed 24-hour urine protein >1.0 g.
- Prior radiotherapy (except palliative bone radiation), chemotherapy, or surgery (excluding biopsy) within 4 weeks before treatment initiation; <4 weeks since last antibody therapy; <5 half-lives since last targeted therapy (including investigational agents); or unresolved toxicities (>CTCAE grade 1, except alopecia).
- Active infection, unexplained fever ≥38.5°C within 7 days, or baseline WBC >15×10⁹/L.
- Immunodeficiency (e.g., HIV); HBsAg-positive with HBV DNA ≥2000 IU/mL; or HCV antibody-positive.
- Active or history of autoimmune diseases (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Exceptions: vitiligo, childhood asthma resolved without intervention, or stable hypothyroidism on hormone replacement.
- Live vaccination within 4 weeks prior to treatment or planned during the study.
- Planning pregnancy, pregnancy, or suckling period;
- The investigator judged that the patients are not suitable for participating in this trial.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Zhong-Sheng Tong, MD, +862223340123 ext. 2131, 18622221181@163.com
Wei-Peng Zhao, MD, +86 13662040377, maoxun1977@163.com
About this study
This is a single-arm, prospective, Phase II clinical trial designed to assess the efficacy and safety of QL1706 in combination with olaparib in patients with recurrent or metastatic triple-negative breast cancer (TNBC) harboring homologous recombination repair deficiency (HRD) who have received prior therapy.
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- QL1706 Plus Olaparib
- 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.
QL1706 Plus OlaparibDrug
QL1706: 5 mg/kg administered via intravenous (IV) infusion every 3 weeks (Q3W). Olaparib: 300 mg (two 150 mg tablets) taken orally twice daily (BID). Treatment will continue until protocol-defined discontinuation criteria are met, including disease progression, unacceptable toxicity, withdrawal of consent, or death.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 + Olaparib | Experimental | Not described Receives: Drug: QL1706 Plus Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) - investigator assessment
Measured: Up to 2 years
Secondary outcomes (4)
Objective response rate (ORR) - Investigator assessment
Measured: Up to 2 years
Duration of response (DOR) - Investigator assessment
Measured: Up to 2 years
Overall survival (OS)
Measured: Up to 5 years
Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion20 May 2030 (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 Tianjin Medical University Cancer Institute and 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
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005583
- Sponsor's protocol ID
- E20250403
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 5 Jun 2025
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of QL1706 in Combination With Olaparib for the Treatment of Patients With Previously Treated Homologous Recombination Repair-Deficient Recurrent or Metastatic Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07005583
- Acronym / sponsor ID
- E20250403
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 20 May 2030 (estimated)
- First posted
- 5 Jun 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 is a single-arm, prospective, Phase II clinical trial designed to assess the efficacy and safety of QL1706 in combination with olaparib in patients with recurrent or metastatic triple-negative breast cancer (TNBC) harboring homologous recombination repair deficiency (HRD) who have received prior therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 + Olaparib | Experimental | Drug: QL1706 Plus Olaparib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
- Female breast cancer patients aged ≥18 and ≤75 years, with histologically or cytologically confirmed recurrent or metastatic triple-negative breast cancer (TNBC) as defined by the latest ASCO/CAP guidelines (based on the most recent biopsy or other pathological specimens).
- Have received at least 1 but no more than 2 prior lines of anti-tumor therapy （ Disease progression during or within 12 months after completing neoadjuvant/adjuvant therapy counts as one line of therapy；Must have received taxane-based therapy at any stage；A maximum of 1 prior antibody-drug conjugate (ADC) therapy is allowed.）
- Documented homologous recombination repair deficiency (HRD) (BRCA1/2 mutation and/or HRD-positive status.
- Any PD-L1 expression status (no restriction).
Key exclusion criteria (22 listed)
- Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1, anti-CTLA-4) or PARP inhibitors (e.g., olaparib, niraparib).
- Current use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
- History of severe allergic reactions to monoclonal antibodies.
- 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.
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 Plus OlaparibQL1706: 5 mg/kg administered via intravenous (IV) infusion every 3 weeks (Q3W). Olaparib: 300 mg (two 150 mg tablets) taken orally twice daily (BID). Treatment will continue until protocol-defined discontinuation criteria are met, including disease progression, unacceptable toxicity, withdrawal of consent, or death. | Drug | QL1706 + Olaparib |
Primary outcome
Progression-Free Survival (PFS) - investigator assessment
Time frame: Up to 2 years
4 secondary outcomes
Objective response rate (ORR) - Investigator assessment
Time frame: Up to 2 years
Duration of response (DOR) - Investigator assessment
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 5 years
Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Time frame: Up to 5 years
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 5 Jun 2025.
- 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 QL1706 Plus Olaparib in people with Triple-Negative Breast Cancer (TNBC), run by Tianjin Medical University Cancer Institute and 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 11 inclusion and 22 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 5 Jun 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 Zhong-Sheng Tong, MD (+86 022-23340123 ext. 2131, 18622221181@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) - investigator assessment (time frame: Up to 2 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 5 Jun 2025.