Looking at Tumor DNA Before Chemotherapy to Predict Cancer Recurrence in People with High-Risk, Early-Stage Breast Cancer

https://www.facingourrisk.org/research-clinical-trials/study/344/study-looking-at-tumor-dna-to-predict-cancer-recurrence-for-those-planning-to-undergo-chemotherapy-for-high-risk-early-breast-cancer

Clinicaltrials.gov identifier:
NCT06401421 (https://clinicaltrials.gov/show/NCT06401421)

Treatment
Biomarker study for people with early-stage breast cancer

Study Contact Information:

For more information please contact:

NSABP Department of Site and Study Management Department of Site and Study Management

Phone: 1-800-270-3165

Email: [email protected]

About the Study

This trial is looking at whether the study of a type of biomarker called circulating tumor DNA (ctDNA) can predict the likelihood of recurrence for people with early-stage breast cancer. The ctDNA test is a blood test that looks for small pieces of DNA from cancer cells in the bloodstream.

What the Study Involves

Blood and tissue samples will be collected for the ctDNA test.

Participants will provide 34 cc (2.5 Tablespoons) of blood for each research blood draw.
Participants will provide a tissue sample from a breast biopsy or a lymph node.

Patient outcomes will be monitored for six years.

This Study is Open To:

People who are 18 years or older can participate if they meet all of the following criteria:

Diagnosed with early-stage breast cancer.
Are planning to receive chemotherapy before surgery (neoadjuvant chemotherapy).
Have a tumor size of 2.1 cm or larger.
Have one of the following:
1. spread to lymph nodes (lymph node positive), or
2. Triple-negative or HER2+, or
3. HR-positive/HER2-negative with at least one of the following:
  1. high grade tumor
  2. high Ki67 index of 20% or higher (Ki67 scale is often used in a cancer diagnosis to assess how quickly a tumor is growing).
  3. High genomic risk score (measurement of an individual’s predisposition to breast cancer).
They agree to provide blood for each research blood draw.
They are able to provide a tissue sample from a previous breast biopsy or a lymph node.

This Study is Not Open To:

People with the following are not eligible to participate:

Have metastatic cancer.
Have already started treatment to try to shrink the breast cancer tumor.
Completed treatment less than 5 years ago for a previously-diagnosed cancer.
Have two or more separate breast tumors in the same or opposite breast.

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.