Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06551220
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns
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': 'C000614160', 'term': 'trastuzumab deruxtecan'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Paraffin section'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.', 'description': 'The Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was used as the standard for evaluating treatment response to T-DXd. The response was evaluated based on the change in the tumor relative to baseline and was categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Objective response rate (ORR) is defined as the proportion of patients who achieved CR or PR.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.', 'description': 'The Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was used as the standard for evaluating treatment response to T-DXd. The response was evaluated based on the change in the tumor relative to baseline and was categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Disease control rate (DCR) was defined as the proportion of patients who achieved CR, PR, or SD.'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'From screening and every 2-6 weeks up to progressive disease, or unacceptable toxicity, assessed up to 60 months.', 'description': 'The Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was used as the standard for evaluating treatment response to T-DXd. The response was evaluated based on the change in the tumor relative to baseline and was categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The clinical benefit rate (CBR) was defined as the proportion of patients who achieved CR, PR, or SD for at least 24 weeks.'}], 'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months.', 'description': 'Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.', 'description': 'Overall survival (OS) is defined as the time from treatment initiation to death from any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Trastuzumab Deruxtecan', 'HER2'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is:\n\n\\- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a multicenter, retrospective study led by the Sun Yat-sen University Cancer Center. A total of 16 centers are planned to participate in the study, and it aims to include patients with advanced or locally unresectable breast cancer who have received treatment with T-DXd.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced or locally unresectable breast cancer;\n* Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;\n* HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;\n* Measurable lesions with treatment response results that can be evaluated through imaging examinations;\n* Able to follow up with the latest progression-free survival or overall survival.\n\nExclusion Criteria:\n\n* Patients with missing basic clinical information or HER2 immunohistochemistry staining information;\n* Patients with missing pathological results for both primary and metastatic/recurrent lesions;\n* Patients with no measurable lesions and unable to evaluate T-DXd treatment response;\n* Discontinue T-DXd therapy for unacceptable adverse events or other reasons;\n* Patients lost to follow-up after T-DXd treatment.'}, 'identificationModule': {'nctId': 'NCT06551220', 'acronym': 'HEROIC', 'briefTitle': 'Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'HER2 Heterogeneity and Its Impact on Benefit from Trastuzumab Deruxtecan in Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'SYSUCC-B2022-617-X01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trastuzumab Deruxtecan', 'interventionNames': ['Drug: Trastuzumab Deruxtecan']}], 'interventions': [{'name': 'Trastuzumab Deruxtecan', 'type': 'DRUG', 'description': 'The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.', 'armGroupLabels': ['Trastuzumab Deruxtecan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiwei Huang', 'role': 'CONTACT', 'email': 'haungstudenth@163.com', 'phone': '86-591-62002050'}], 'facility': 'Fujian Cancer Hospital, Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Dongguan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyu Chen', 'role': 'CONTACT', 'email': 'chenxy769@mail3.sysu.edu.cn', 'phone': '86-0769-28637920'}], 'facility': 'The 10th Affiliated Hospital of Southern Medical University', 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'city': 'Foshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lewei Zhu', 'role': 'CONTACT', 'email': 'zlwei@fsyyy.com', 'phone': '86-0757-83833633'}], 'facility': "The First People's Hospital of Foshan", 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'city': 'Foshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pangzhou Chen', 'role': 'CONTACT', 'email': 'lychenpz@scut.edu.cn', 'phone': '86-0757-89932927'}], 'facility': 'The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoming Xie, MD, PhD', 'role': 'CONTACT', 'email': 'xiexm@sysucc.org.cn', 'phone': '86-020-87343806'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qianjun Chen, MD', 'role': 'CONTACT', 'email': 'cqj55@163.com', 'phone': '86-020-39318100'}], 'facility': 'Guangdong Provincial Hospital of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongsheng Li', 'role': 'CONTACT', 'email': 'lihongsheng@gzhmu.edu.cn', 'phone': '86-020-66673666'}], 'facility': 'The Affiliated Cancer Hospital, Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weige Tan', 'role': 'CONTACT', 'email': 'tanweige@gzhmu.edu.cn', 'phone': '86-020-83062114'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Huang', 'role': 'CONTACT', 'email': 'huangmeigztcm@163.com', 'phone': '86-020-36591912'}], 'facility': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shaoguan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuansheng Yang', 'role': 'CONTACT', 'email': 'ychssmile@163.com', 'phone': '86-0751-691330'}], 'facility': "Yuebei People's Hospital of Shantou University", 'geoPoint': {'lat': 24.8, 'lon': 113.58333}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caiwen Du', 'role': 'CONTACT', 'email': 'dusumc@aliyun.com', 'phone': '86-0755-66618168'}], 'facility': 'National Cancer Center Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Hu', 'role': 'CONTACT', 'email': 'hu.hong@szhospital.com', 'phone': '86-0755-25533018'}], 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shien Cui', 'role': 'CONTACT', 'email': 'cuishiencse@163.com', 'phone': '86-0760-89880389'}], 'facility': "Zhongshan City People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peijian Peng, MD', 'role': 'CONTACT', 'email': 'pengpjian@163.com', 'phone': '86-756-2528015'}], 'facility': 'The Fifth Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}, {'city': 'Changde', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Wu', 'role': 'CONTACT', 'email': 'radiotherapy_wutao@qq.com', 'phone': '86-0736-7788000'}], 'facility': 'Changde Hospital, Xiangya School of Medicine, Central South University', 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quchang Ouyang, MD', 'role': 'CONTACT', 'email': 'oyqc1969@126.com', 'phone': '86-0731-89762160'}], 'facility': 'Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenjun Yi', 'role': 'CONTACT', 'email': 'yiwenjun@csu.edu.cn', 'phone': '0731-85295999'}], 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Hengyang', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuehua Li', 'role': 'CONTACT', 'email': 'liyuehua2020@stu.usc.edu.cn', 'phone': '86-0734-8279467'}], 'facility': 'The First Affiliated Hospital, Hengyang Medical School, University of South China', 'geoPoint': {'lat': 26.88946, 'lon': 112.61888}}, {'city': 'Hohhot', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiu-Mei Wang', 'role': 'CONTACT', 'email': 'wangxiumei75@163.com', 'phone': '86-0471-6575447'}], 'facility': 'Affiliated Cancer Hospital of Inner Mongolia Medical University', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianchun Gu', 'role': 'CONTACT', 'email': 'gujianchun@126.com', 'phone': '021-26077653'}], 'facility': 'Xinhua Hospital Afliated to Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingkuan Shao', 'role': 'CONTACT', 'email': 'ykshao@zju.edu.cn'}], 'facility': 'The Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'status': 'RECRUITING', 'contacts': [{'name': 'Haoming Wu', 'role': 'CONTACT', 'email': 'ahand@126.com', 'phone': '86-0754-88599616'}], 'facility': 'Cancer Hospital of Shantou University Medical College'}, {'status': 'RECRUITING', 'contacts': [{'name': 'Songming Li', 'role': 'CONTACT', 'email': '36602798@qq.com', 'phone': '86-020-34859190'}], 'facility': 'The Affiliated Panyu Central Hospital, Guangzhou Medical University'}], 'centralContacts': [{'name': 'Xiaoming Xie, MD, PhD', 'role': 'CONTACT', 'email': 'xiexm@sysucc.org.cn', 'phone': '86-020-87343806'}, {'name': 'Yutian Zou, MD, PhD', 'role': 'CONTACT', 'email': 'zouyt@sysucc.org.cn', 'phone': '86-020-87343806'}], 'overallOfficials': [{'name': 'Xiaoming Xie, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yutian Zou', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}