RecruitingNot ApplicableNCT05058183

Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

400 participants

Start Date

Jun 5, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a blood-based biomarker test (ctDNA or "liquid biopsy") can safely identify stage 1 breast cancer patients who don't need full chemotherapy after surgery, allowing some people to skip chemo if their risk is low. This is called "de-escalation" — doing less treatment when it may be equally safe. **You may be eligible if...** - You are 18 or older with confirmed stage 1 breast cancer (tumor 6–20mm) - Your cancer is either HER2-positive or triple-negative - You are willing to have blood tests at multiple timepoints **You may NOT be eligible if...** - Your cancer is a different subtype (e.g., hormone receptor-positive, HER2-negative) - Your tumor is very small (under 5mm) with no lymph node involvement - You have stage 2 or higher cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTctDNA

Patients with stage 1 HER2 positive and triple negative breast cancer will receive ctDNA test after surgery. Treating clinicians will receive results and may change treatment plans in event of negative test.

Locations(2)

The Royal Marsden NHS Foundation Trust, Chelsea

London, United Kingdom

The Royal Marsden NHS Foundation Trust, Sutton

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05058183

Related Trials

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

NCT072146624 locations

Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25

NCT058799261238 locations

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

NCT06790693226 locations

A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.

NCT07062965384 locations

Genomic Services Research Program

NCT025959571 location