The HER2-RADiCAL study (Response ADaptive CAre pLan) – tailoring treatment for HER2 positive early breast cancer

Institute of Cancer Research0 sites720 target enrollmentOctober 11, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 11, 2021

End Date

November 30, 2029

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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