Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 9:25 PM
Study NCT ID:
NCT06967103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 238}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathological complete response', 'timeFrame': 'up to 24 weeks', 'description': 'After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)'}, {'measure': 'pathological complete response in PDL1 positive subgroup', 'timeFrame': 'up to 24 weeks', 'description': 'After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)'}], 'secondaryOutcomes': [{'measure': 'Event-Free Survival (EFS)', 'timeFrame': '5-10 years', 'description': 'Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 24 weeks', 'description': 'ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)'}, {'measure': 'adverse events', 'timeFrame': 'up to 24 weeks', 'description': 'Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD1', 'CTLA4', 'breast cancer'], 'conditions': ['Breast Cancer', 'HR+/HER2- Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are:\n\nDoes QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nSubjects meeting all of the following criteria are eligible for inclusion in this study:\n\nVoluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.\n\nFemale, aged ≥18 years .\n\nEvaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.\n\ncT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；\n\nHistologically and/or cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor \\[ER\\] or progesterone receptor \\[PR\\] nuclear staining \\>1%) with Ki67 ≥20%.\n\nHER2-negative breast cancer, defined as:\n\nNegative in situ hybridization (ISH) results; or\n\nImmunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative.\n\nWilling to provide fresh or archived tumor tissue samples.\n\nAt least one measurable lesion per RECIST 1.1 criteria.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nAdequate organ function, defined as:\n\nHematology:\n\nHemoglobin ≥90 g/L\n\nAbsolute neutrophil count ≥1.5 × 10⁹/L\n\nPlatelet count ≥100 × 10⁹/L.\n\nBiochemistry:\n\nALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present);\n\nTotal bilirubin ≤1.5 × ULN;\n\nSerum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min.\n\nCoagulation:\n\nActivated partial thromboplastin time (APTT) ≤1.5 × ULN;\n\nInternational normalized ratio (INR) ≤1.5 × ULN.\n\nCardiac function:\n\nLeft ventricular ejection fraction (LVEF) ≥50% by echocardiography.\n\nPremenopausal or perimenopausal subjects must agree to use reliable and effective contraception or practice abstinence from the time of informed consent until at least 90 days after the last dose of study treatment.\n\nExclusion Criteria\n\nSubjects meeting any of the following criteria will be excluded from this study:\n\nKnown severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients.\n\nStage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator.\n\nInflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma).\n\nMajor surgery or significant trauma within 28 days prior to the first dose.\n\nAdministration of live attenuated vaccines within 28 days before the first dose or anticipated during the study.\n\nSystemic corticosteroids or immunosuppressive therapy within 14 days prior to the first dose or anticipated during the study.\n\nActive autoimmune disease requiring systemic treatment within 2 years prior to enrollment, or history of autoimmune disorders.\n\nSevere systemic infection within 28 days or active infection requiring intravenous/oral antibiotics within 14 days prior to the first dose.\n\nPrior organ or allogeneic bone marrow transplantation or awaiting transplantation.\n\nHistory or evidence of interstitial lung disease or active non-infectious pneumonitis.\n\nBleeding tendency or high risk of hemorrhage.\n\nThromboembolic events (e.g., cerebrovascular accident, pulmonary embolism) within 6 months prior to enrollment.\n\nCongenital or acquired immunodeficiency (e.g., HIV infection).\n\nActive hepatitis:\n\nHepatitis B: HBsAg-positive with HBV DNA ≥2000 IU/mL;\n\nHepatitis C: HCV antibody-positive with HCV RNA above the upper limit of normal.\n\nPoorly controlled cardiac conditions, including:\n\nNYHA Class II or higher heart failure or LVEF \\<50%;\n\nUnstable angina;\n\nMyocardial infarction within 1 year;\n\nQTc interval \\>470 ms (female) on resting ECG.\n\nOther malignancies within 5 years (excluding basal cell carcinoma or cervical carcinoma in situ).\n\nUse of investigational drugs within 4 weeks prior to the first dose.\n\nHistory or current diagnosis of neurological or psychiatric disorders (e.g., epilepsy, dementia).\n\nHistory of pancreatitis.\n\nPregnancy, lactation, or refusal to use contraception.\n\nAny other condition deemed inappropriate for participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT06967103', 'briefTitle': 'QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'QL1706 Combined With PE Compared With PE for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer', 'orgStudyIdInfo': {'id': 'HELEN-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QL1706 group', 'description': 'NabPE+QL1706 every 3 weeks for 6 cycles. Then participants will receive surgery and QL1706 will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment.', 'interventionNames': ['Drug: QL1706', 'Drug: Nab-PE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NabPE group', 'description': 'NabPEevery 3 weeks for 6 cycles. Then participants will receive surgery'}], 'interventions': [{'name': 'QL1706', 'type': 'DRUG', 'description': 'bispecific antibody targeting PD-1 and CLTA-4', 'armGroupLabels': ['QL1706 group']}, {'name': 'Nab-PE', 'type': 'DRUG', 'description': 'Nab-paclitaxel+Epirubicin', 'armGroupLabels': ['QL1706 group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhenzhen Liu', 'role': 'CONTACT', 'email': 'zlyyliuzhenzhen0800@zzu.edu.cn', 'phone': '13603862755'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhenzhen Liu', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}