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CtDNA Based MRD Testing for NAC Monitoring in TNBC

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with stage I–III triple-negative breast cancer who will have chemotherapy before surgery. It looks at whether a blood test that finds small amounts of cancer DNA matches whether any cancer is found in tissue after chemotherapy.

A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have triple-negative breast cancer confirmed by a tissue test that meets the study’s lab rules.
  • Have stage I–III breast cancer.
  • Be scheduled to start chemotherapy before surgery, with the goal of curing the cancer.
  • Be told about the study and understand what taking part means.
  • Be willing and able to sign a written consent form.
  • Be willing to give blood samples before and during treatment.
  • Have tissue from a biopsy available for testing.

Who can't join

  • Be receiving cancer treatment for another cancer at the same time.
  • Have stage IV breast cancer, which has spread to distant parts of the body.
  • Have another cancer now or within the past 5 years, except basal or squamous cell skin cancer or cancer that has not grown into nearby tissue.
  • Have had a bone marrow transplant from a donor or an organ transplant.
  • Have received a blood transfusion within 2 weeks before the study’s cancer DNA blood test.
  • Have already started breast cancer treatment that works throughout the body.
  • Be pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio \<2 or HER2 gene copy number of \<6). 2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent. 3. Be informed of the investigational nature of the study and all pertinent aspects of the trial. 4. Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines. 5. Be ≥ 18years of age. 6. Patient who are scheduled to start NAC. 7. Be willing to provide blood samples before and during treatment. 8. Have available biopsy tissue. Exclusion Criteria: 1. Receiving concurrent anti-neoplastic therapy for another malignancy. 2. Stage IV disease. 3. Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy. 4. History of allogeneic bone marrow or organ transplant. 5. Blood transfusion within two weeks before collection of blood for central ctDNA testing. 6. Started systemic therapy for their breast cancer. 7. Pregnancy

Study sites (14)

AZ

CO

DC

FL

IL

LA

MI

NE

NY

OR

PA

TX

WA