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Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to assess the rates of circulating tumour DNA (ctDNA) in patients treated with surgery for stage 1 breast cancer that is HER2 positive or triple negative. The study will involve collecting blood samples from patients before and after surgery, if patients are enrolled after surgery, blood samples will be collected after the procedure. On the follow-up visit, the results obtained from the blood tests will serve as a diagnostic method to discern adverse outcomes in the groups of patients with positive and negative ctDNA detection. Also, the results obtained will aid physicians in determining treatment courses for patients, in order to reduce the intensity of adjuvant chemotherapy. By identifying the patients with residual disease with ctDNA analysis, it is possible that this will improve disease prognosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older.

• Patients with histologically confirmed breast cancer that is either

• A) HER2 positive as defined by 2018 ASCO-CAP guidelines determined by local testing 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 2018 ASCO-CAP guidelines determined by local testing. Patients without PR testing results may enrol on the basis of ER and HER2 results.

• Note that patients negative for ER and PR may enrol whilst awaiting HER2 testing results

• Stage 1 cancer excluding pT1aN0 cancer, defined as

• A) Patients prior to surgery with primary tumour size on imaging 6-20mm and a normal axilla ultrasound or a biopsy negative axilla

• Patients who enrol prior to surgery will only continue further testing in the trial if their pathological staging fits the after surgery criteria.

• B) Patients after surgery with either

⁃ Primary tumour size pT1b or pT1c (6-20mm) and pN0 or pN1mi (micrometastasis).

⁃ Primary tumour size pT1a (1-5mm) and pN1mi

• Note that patients consenting after surgery may not enrol with pT1aN0 stage disease

• Patients should consent prior to surgery (preferred) or within 2 weeks of surgery. Patients who consent after surgery may extend consent to 4 weeks after surgery, although this will delay the receipt of ctDNA results.

• Planned and fit enough to receive full standard post-operative chemotherapy, with HER2 targeting as appropriate.

• Ability to give informed consent and comply with study procedures including blood tests and follow-up for five years.

Locations
Other Locations
United Kingdom
The Royal Marsden NHS Foundation Trust, Chelsea
RECRUITING
London
The Royal Marsden NHS Foundation Trust, Sutton
RECRUITING
Sutton
Contact Information
Primary
Project Manager
SAFE-DE@rmh.nhs.uk
020 7808 2887
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2028-12-05
Participants
Target number of participants: 400
Treatments
Experimental: All participants
All participants
Related Therapeutic Areas
Sponsors
Collaborators: Natera, Inc., Massachusetts General Hospital
Leads: Royal Marsden NHS Foundation Trust

This content was sourced from clinicaltrials.gov

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