Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT07254858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'C000632826', 'term': 'sintilimab'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 302}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The breast-conserving rate of breast malignant tumor surgery', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'The breast-conserving rate of breast malignant tumor surgery'}], 'primaryOutcomes': [{'measure': 'Pathological complete response rate（pCR）', 'timeFrame': 'Pathological diagnosis results were obtained tithin one month after the operation', 'description': 'Postoperative pathological assessment (tumor Miller-Payne system grading and axillary lymph node pathological assessment)'}], 'secondaryOutcomes': [{'measure': 'Objective response rate(ORR)', 'timeFrame': 'At the end of Cycle 8 (each cycle is 28 days)', 'description': 'The proportion of patients achieving complete response (CR) and partial response (PR) after tumor treatment was used as the second endpoint of the primary endpoint for hierarchical testing.'}, {'measure': 'Event-free survival rate', 'timeFrame': 'Long-term follow-up monitoring was conducted until 3 years after enrollment', 'description': 'The time from randomization to the event (recurrence, metastasis or death)'}, {'measure': 'Incidence of adverse reactions', 'timeFrame': '1 year', 'description': 'Continuous monitoring, assessment and patient feedback.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Radiotherapy', 'Immunotherapy'], 'conditions': ['HR+/HER2- Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy in the neoadjuvant treatment of high-risk HR+/HER2- breast cancer patients.\n\nThe study plans to enroll treatment-naïve HR+/HER2- breast cancer patients aged 18-75 with high-risk features (e.g., tumor size ≥3 cm or lymph node positivity, Ki-67 ≥20%). Eligible subjects will be randomized in a 1:1 ratio into two groups: the control group will receive neoadjuvant chemotherapy (nab-paclitaxel followed by epirubicin + cyclophosphamide) in combination with sintilimab immunotherapy; the experimental group will receive the same chemotherapy and immunotherapy regimen with the addition of stereotactic body radiotherapy (SBRT) administered early during treatment, at a prescribed dose of 8 Gy per fraction for 3 fractions, with one fraction per day.\n\nThe study has dual primary endpoints: pathological complete response (pCR,) and objective response rate (ORR ). Secondary endpoints include 3-year event-free survival (EFS), incidence of adverse events (CTCAE v5.0), and postoperative cosmetic outcomes of the breast. The study design incorporates hierarchical testing to control for multiplicity, and long-term follow-up is planned to evaluate survival benefits.\n\nThe study has been approved by the ethics committee, and all participants are required to provide written informed consent. The results are expected to offer a novel neoadjuvant treatment strategy for high-risk HR+/HER2- breast cancer patients and improve their therapeutic outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed, untreated breast cancer;\n2. Age: 18 years ≤ age ≤ 75 years;\n3. Histologically confirmed hormone receptor-positive (HR+) tumor specimen (estrogen receptor \\[ER\\] ≥ 10%);\n4. Human epidermal growth factor receptor-2 immunohistochemistry (HER2-IHC) result of 0/1+ or 2+ with negative fluorescence in situ hybridization (FISH) test;\n5. Histologically confirmed cell proliferation index (Ki67) ≥ 20%;\n6. Programmed death-ligand 1 combined positive score (PD-L1 CPS) evaluable (i.e., availability of fresh/archived specimens);\n7. Good pulmonary function;\n8. Adequate hepatic and renal function;\n9. Histological grade ≥ 2;\n10. cN0, cT ≥ 3 cm or cN1-3, cT ≥ 2 cm (cT: clinically assessed maximum diameter of primary tumor; cN: clinically assessed regional lymph node status);\n11. Eastern Cooperative Oncology Group Performance Status (ECOG score) 0-1. Exclusion Criteria:\n\n1.Pregnancy; 2.Tumor \\> 8 cm with skin ulceration; 3.History of thoracic radiotherapy or contraindications to radiotherapy; 4.Active autoimmune disease; 5.Prior use of PD-L1 antibody therapy; 6.De novo breast cancer; 7.There are factors that may significantly increase the risk of lung or cardiac toxicity related to radiotherapy, such as (1) maximum lung depth(MLD) \\>3.2cm； (2) maximum heart distance(MHD) \\<2.4cm。'}, 'identificationModule': {'nctId': 'NCT07254858', 'acronym': 'CISN-L', 'briefTitle': 'Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer: A Prospective Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KY2025-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy+Immunotherapy', 'description': 'Control Group: Neoadjuvant chemotherapy combined with immunotherapy, wherein the neoadjuvant chemotherapy regimen follows the clinical standard protocol.\n\nNeoadjuvant Chemotherapy Regimen:\n\nA sequential chemotherapy strategy is adopted, with the specific regimen as follows:\n\nTaxane-based Chemotherapy Phase (T Phase):\n\nNab-paclitaxel (125 mg/m²), administered by intravenous infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 4 cycles.\n\nAnthracycline-based Combination Chemotherapy Phase (EC Phase):\n\nEpirubicin (75-100 mg/m²) in combination with cyclophosphamide (600 mg/m²), administered by intravenous infusion every 21 days (Q3W), for a total of 4 cycles.\n\nThe EC phase commences upon completion of the T phase.\n\nImmunotherapy Regimen:\n\nSintilimab (200 mg), administered by intravenous infusion every three weeks (Q3W).\n\nDosing begins on Day 2 of the chemotherapy cycles, for a total of 8 treatment cycles.', 'interventionNames': ['Drug: Neoadjuvant Chemotherapy (NACT)', 'Drug: Immunotherapy (Sintilimab)']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy + Immunotherapy + Radiotherapy', 'description': 'Neoadjuvant chemotherapy combined with immunotherapy（same as Arm1) + Neoadjuvant Radiotherapy', 'interventionNames': ['Radiation: Neoadjuvant radiotherapy', 'Drug: Neoadjuvant Chemotherapy (NACT)', 'Drug: Immunotherapy (Sintilimab)']}], 'interventions': [{'name': 'Neoadjuvant radiotherapy', 'type': 'RADIATION', 'description': 'Neoadjuvant Radiotherapy Regimen:\n\n1. Radiotherapy Technique: Stereotactic Body Radiation Therapy (SBRT) Radiation Dose and Fractionation: 8 Gy per fraction, for a total of 3 fractions, amounting to a total dose of 24 Gy\n2. Radiotherapy Schedule: Irradiation begins on the second day of the first chemotherapy cycle and is administered every other day\n3. Target Volume Definition: The radiotherapy target volume is defined based on baseline imaging (e.g., CT, MRI, or PET-CT)\n4. Radiotherapy Equipment and Planning: Treatment is delivered using a linear accelerator equipped with Image-Guided Radiotherapy (IGRT) technology to ensure precise irradiation and dose optimization', 'armGroupLabels': ['Chemotherapy + Immunotherapy + Radiotherapy']}, {'name': 'Neoadjuvant Chemotherapy (NACT)', 'type': 'DRUG', 'description': 'Neoadjuvant Chemotherapy Regimen:\n\nA sequential chemotherapy strategy is adopted, with the specific regimen as follows:\n\nTaxane-based Chemotherapy Phase (T Phase):\n\nNab-paclitaxel (125 mg/m²), administered by intravenous infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 4 cycles.\n\nAnthracycline-based Combination Chemotherapy Phase (EC Phase):\n\nEpirubicin (75-100 mg/m²) in combination with cyclophosphamide (600 mg/m²), administered by intravenous infusion every 21 days (Q3W), for a total of 4 cycles.\n\nThe EC phase commences upon completion of the T phase.', 'armGroupLabels': ['Chemotherapy + Immunotherapy + Radiotherapy', 'Chemotherapy+Immunotherapy']}, {'name': 'Immunotherapy (Sintilimab)', 'type': 'DRUG', 'description': 'Immunotherapy Regimen:\n\nSintilimab (200 mg), administered by intravenous infusion every three weeks (Q3W).\n\nDosing begins on Day 2 of the chemotherapy cycles, for a total of 8 treatment cycles.', 'armGroupLabels': ['Chemotherapy + Immunotherapy + Radiotherapy', 'Chemotherapy+Immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Professor Wang', 'role': 'CONTACT', 'email': 'woc099@163.com', 'phone': '86+13957706099'}], 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Wang Ouchen', 'investigatorAffiliation': 'First Affiliated Hospital of Wenzhou Medical University'}}}}