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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Katie
Goddard
+44 (0)20 8722 4185
her2radical-icrctsu@icr.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
HER2-positive early breast cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
Patients with the “HER2-positive” type of early breast cancer (HER2+ EBC) usually receive a course of drug treatment as well as surgery. This drug treatment improves chances of cure by destroying any breast cancer cells that might have already begun to spread. The aim is to reduce the burden of treatment and the risk of serious long-term side effects for some patients with HER2+ EBC. The researchers want to find out if they can adjust the amount of drug treatment given to patients after surgery according to the way the cancer initially responds to drug treatment before surgery.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
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)
OR
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 c
You may not be able to take part if:
Current exclusion criteria as of 21/12/2023:1. Evidence of metastatic disease at any time since diagnosis2. 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 protocol3. 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 carcinoma7. Breast cancer with clinical stage of T≥3 at diagnosis8. 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 pCR10. Pregnant and/or lactating women11. 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 trastuzumab12. Previous diagnosis of invasive breast carcinoma13. 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 neoplasia14. 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 instability17. Left ventricular ejection fraction (LVEF) less than 50% on most recent cardiac imaging18. History of interstitial lung disease19. Any medical or other contra-indication to continuing trastuzumab
Previous exclusion criteria:1. Evidence of metastatic disease at any time since diagnosis2. 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 protocol3. Any planned further resectional surgery for breast cancer (including re-excision, mastectomy, or axillary surgery)4. HER2-negative invasive breast carcinoma5. Breast cancer with clinical stage of T≥3 at diagnosis6. Evidence of scarring (or other pathological features consistent with previous malignant involvement) in >4 axillary nodes or clinical nodal stage N≥2 at any time7. Positive SLNB pre-neoadjuvant systemic therapy as this precludes determination of pCR8. Pregnant and/or lactating women9. 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 trastuzumab10. Previous diagnosis of invasive breast carcinoma11. 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 neoplasia12. Chemotherapy administered following surgery (NB. Pertuzumab and/or trastuzumab may have been continued after surgery as per local practice prior to study entry)13. Has received >9 cycles trastuzumab14. Any medical or other contra-indication to continuing trastuzumab
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Katie
Goddard
+44 (0)20 8722 4185
her2radical-icrctsu@icr.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Institute of Cancer Research and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: ..
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 50425
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