ISRCTN81408940进行中（未招募）未知
The HER2-RADiCAL study (Response ADaptive CAre pLan) – tailoring treatment for HER2 positive early breast cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 21/12/2023:
- •1. Female or male, age =16 years
- •2. Histologically confirmed invasive breast cancer that is HER2-positive (IHC3+, and/or ISH positive/amplified) as determined by the local laboratory in accordance with national guidelines
- •3. Has received neoSACT chemotherapy with concomitant trastuzumab and pertuzumab
- •4. pCR (ypT0/is ypN0) in breast and sampled regional lymph nodes as per local pathology reporting
- •5. Imaging of breast and axilla prior to initiation of neoSACT and either:
- •5.1. Breast primary radiological measurement =20 mm prior to neoSACT and limited nodal involvement (cN1) confirmed by axillary core biopsy or FNA (cT1N1)
- •5.2. Breast primary radiological measurement >20 mm but =50 mm and node-negative (cT2N0) or limited nodal involvement (cT2N1)
- •6. Multiple ipsilateral cancers are permitted provided at least one meets the tumour size and axillary node inclusion criteria and none meet any of the exclusion criteria
- •7. Bilateral cancers are permitted provided at least one meets the tumour size and axillary node inclusion criteria and none meet any of the exclusion criteria
- •8. Pre-treatment diagnostic breast tumour biopsy sample available
- •9. Patient must be fit to continue treatment with trastuzumab and have no concomitant medical, psychiatric or social problems that might interfere with informed consent, adherence to the reduced treatment pathway or follow-up
- •10. Provision of written informed consent to participate in HER2-RADiCAL
- •Previous inclusion criteria:
- •1. Female or male, age =16 years
- •2. Histologically confirmed invasive breast cancer that is HER2-positive (IHC3+, and/or ISH positive/amplified) as determined by the local laboratory in accordance with national guidelines
- •3. Has received neoSACT with a non-anthracycline chemotherapy regimen with at least 3 cycles of concomitant trastuzumab and pertuzumab
- •4. pCR (ypT0/is ypN0) in breast and sampled regional lymph nodes as per local pathology reporting
- •5. Imaging of breast and axilla prior to initiation of neoSACT and either:
- •5.1. Breast primary radiological measurement =20 mm prior to neoSACT and limited nodal involvement (cN1) confirmed by axillary core biopsy or FNA (cT1N1)
- •5.2. Breast primary radiological measurement >20 mm but =50 mm and node-negative (cT2N0) or limited nodal involvement (cT2N1)
- •6. Multiple ipsilateral cancers are permitted provided at least one meets the tumour size and axillary node inclusion criteria and none meet any of the exclusion criteria
- •7. Bilateral cancers are permitted provided at least one meets the tumour size and axillary node inclusion criteria and none meet any of the exclusion criteria
- •8. Pre-treatment diagnostic breast tumour biopsy sample available
- •9. Study consent =6 weeks after completing breast cancer surgery
- •10. Patient must be fit to continue treatment with trastuzumab and have no concomitant medical, psychiatric or social problems that might interfere with informed consent, adherence to the reduced treatment pathway or follow-up
- •11. Provision of written informed consent to participate in HER2-RADiCA
排除标准
- •Current exclusion criteria as of 21/12/2023:
- •1. Evidence of metastatic disease at any time since diagnosis
- •2. Any residual invasive disease following neoSACT. This includes isolated tumour cells in axillary nodes or tissue or evidence of lymphovascular invasion in the breast. Persistent ductal or lobular non-invasive disease (DCIS or LCIS) is permitted. Resection margins must be deemed clear of any residual DCIS according to local MDT protocol
- •3. Breast-conserving primary surgery where it is known that breast irradiation will not be administered (e.g. due to contraindication or patient preference)
- •4. Intraoperative assessment of post-neoSACT axillary SLN using one-stop nucleic acid amplification (OSNA)
- •5. Any planned further resectional surgery for breast cancer (including re-excision, mastectomy, or axillary surgery)
- •6. HER2-negative invasive breast carcinoma
- •7. Breast cancer with clinical stage of T=3 at diagnosis
- •8. Evidence of scarring (or other pathological features consistent with previous malignant involvement) in >4 axillary nodes or clinical nodal stage N=2 at any time9. Positive SLNB pre-neoadjuvant systemic therapy as this precludes determination of pCR
- •10. Pregnant and/or lactating women
- •11. Female patient of child-bearing potential, unwilling to use an effective form of contraception during trastuzumab treatment and for 7 months after their last dose of trastuzumab
- •12. Previous diagnosis of invasive breast carcinoma
- •13. Previous diagnosis of any other (non-breast) malignancy unless disease-free for at least 5 years and considered to be at low risk of recurrence or treated basal cell or localised squamous cell carcinoma of the skin or cervical intraepithelial neoplasia
- •14. Chemotherapy administered following surgery (NB. Pertuzumab and/or trastuzumab may have been continued after surgery as per local practice prior to study entry)
- •15. Has received >9 cycles trastuzumab. In the event a patient has received 9 cycles prior to study entry then consent must occur within 3 weeks of the last dose of trastuzumab.
- •16. Clinically significant cardiac disease within 12 months of starting trastuzumab, including unstable angina, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure, cerebral vascular accident, or cardiac arrhythmia associated with haemodynamic instability
- •17. Left ventricular ejection fraction (LVEF) less than 50% on most recent cardiac imaging
- •18. History of interstitial lung disease
- •19. Any medical or other contra-indication to continuing trastuzumab
- •Previous exclusion criteria:
- •1. Evidence of metastatic disease at any time since diagnosis
- •2. Any residual invasive disease following neoSACT. This includes isolated tumour cells in axillary nodes or tissue or evidence of lymphovascular invasion in the breast. Persistent ductal or lobular non-invasive disease (DCIS or LCIS) is permitted. Resection margins must be deemed clear of any residual DCIS according to local MDT protocol
- •3. Any planned further resectional surgery for breast cancer (including re-excision, mastectomy, or axillary surgery)
- •4. HER2-negative invasive breast carcinoma
- •5. Breast cancer with clinical stage of T=3 at diagnosis
- •6. Evidence of scarring (or other pathological features consistent with previous malignant involvement) in >4 axillary nodes or clinical nodal stage N=2 at any time
- •7. Positive SLNB pre-neoadjuvant systemic therapy as this precludes determination of pCR
- •8. Pregnant and/or lactating women
研究者
相似试验
已完成
不适用
Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)Breast CancerNCT05415943SDS Optic S.A.18
进行中（未招募）
1 期
PREDIX HER2 - preoperative treatment of HER2 positive breast cancerPrimary breast cancerMedDRA version: 20.0Level: PTClassification code: 10006201Term: Breast cancer stage III Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10006188Term: Breast cancer female NOS Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10006200Term: Breast cancer stage II Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10006191Term: Breast cancer male NOS Class: 10029104CTIS2023-508411-23-00Karolinska University Hospital200
进行中（未招募）
1 期
PREDIX HER2 - preoperative treatment of HER2 positive breast cancerEUCTR2014-000808-10-SEKarolinska University Hospital200
已完成
不适用
Observational study of HER2 positive rate in advanced or recurrent gastric cancerAdvanced or recurrent gastric cancerJPRN-UMIN000006190Japanese Foundation for Multidisciplinary Treatment of Cancer1,200
进行中（未招募）
1 期
A clinical research study to test different doses of a study drug (ARX788), to see which dose is safest and its effectiveness(shrinks tumor size) in patients with advanced cancer.Metastatic Breast Cancer Resistant or RefractoryMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001246-36-ESAmbrx, Inc.210