Reducing chemotherapy for early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the presence of circulating tumor DNA (ctDNA) in patients with stage 1 breast cancer who are HER2 positive or triple negative. Blood samples will be collected before and after surgery to analyze ctDNA levels, which can indicate the likelihood of adverse outcomes. The findings aim to help physicians tailor chemotherapy treatments, potentially allowing for reduced chemotherapy intensity while maintaining effective disease management. By identifying patients with residual disease through ctDNA analysis, the study seeks to improve overall disease prognosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
3. Have an estimated life expectancy of at least 5 years
4. Histologically confirmed breast cancer that is either:

   (A) HER2-positive as defined by 2023 ASCO-CAP guidelines determined by local testing\* or (B) Triple negative defined as ER negative (ER staining in \<1% tumour cells or ER Allred score \<3/8) and PR negative (PR staining in \<10% tumour cells or PR Allred score \<6/8) and HER2-negative by 2023 ASCO-CAP guidelines determined by local testing. Patients without PR testing results may enrol on the basis of ER and HER2 results.

   \* Note: Patients negative for ER and PR may enrol whilst awaiting HER2 testing results
5. Pathological stage 1 cancer as below: \*\*

   EITHER
   1. HER2-positive invasive tumour size 5-20mm OR
   2. TNBC invasive tumour size 5-20mm, with high TILs (stromal tumour infiltration lymphocytes \>30%) determined by central testing

   AND (c) Node negative (isolated tumour cells are allowed)

   \*\*Patients may be enrolled pre-operatively with clinical stage 1 cancer with primary tumour size on imaging 5-20mm and a normal axilla ultrasound or a biopsy negative axilla. Patients enrolled before surgery will only continue in study after surgery when confirmed pathological stage 1
6. Planned for and fit enough to receive standard post-operative chemotherapy, with HER2 targeting as appropriate, in the opinion of the investigator
7. Able and willing to provide written informed consent or remote consent
8. Negative serum pregnancy test at screening (females of childbearing potential). Patients able to have children are advised to use a method of contraception, or abstinence, throughout the ctDNA surveillance period
9. Willing and able to comply with scheduled visits, laboratory tests and other procedures
10. Available tissue from breast surgery or diagnostic core (preference to diagnostic core for rapidity of tissue sequencing).

Exclusion criteria:

1. Prior treatment for the current breast cancer, other than surgery if recruited post-operatively
2. Multifocal invasive cancer
3. Micrometastasis or macrometastasis in axillary lymph nodes
4. pT1a invasive tumour size \<5mm
5. Distant metastatic disease on imaging performed as part of standard of care
6. Planned participation in an alternative treatment trial
7. Diagnosis of alternative cancer within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix
8. Known HIV or AIDS-related illness
9. Known positive HBV or HCV test indicating acute or chronic infection

Where it's running

• Royal Cornwall Hospitals NHS Trust
  Truro, Cornwall, United Kingdom Recruiting
• Royal Bournemouth Hospital
  Bournemouth, United Kingdom Recruiting
• The Clatterbridge Cancer Centre
  Liverpool, United Kingdom Recruiting
• Whittington Hospital
  London, United Kingdom Recruiting
• University College London Hospital
  London, United Kingdom Recruiting
• The Royal Free Hospital
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Nicholas Turner — Royal Marsden NHS Foundation Trust
• Study coordinator: Project Manager
• Email: SAFE-DE@rmh.nhs.uk
• Phone: 020 7808 2887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.