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NCT06087120: BRAVA

Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

Recruiting now Last updated 23 September 2025
What this trial tests

trial in Breast Cancer Female in 125 participants. Currently enrolling.

Timeline
16 September 2023
Primary endpoint
1 December 2025
31 December 2025

Quick facts

Lead sponsorGene Solutions
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment125
Start date16 September 2023
Primary completion1 December 2025
Estimated completion31 December 2025
Sites3 locations across Indonesia, Vietnam

Conditions studied

Sponsor

Gene Solutions

Who can join

18 and older, female only, with Breast Cancer Female or Stage II Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment. * Determine the rate of ctDNA positivity at the time before treatment, * Determine the rate of ctDNA positivity at the time during treatment, * Determine the rate of ctDNA positivity at the time after neoadjuvant therapy, whether there is a change in ctDNA expression of the study population during treatment. And aiming to investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy: * Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA, * Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI * Combination of ctDNA detection and MRI imaging in the prognosis of pCR. Determination of PPV, NPV ratio of ctDNA combined with MRI.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Beyond traditional biopsies: the emerging role of ctDNA and MRD on breast cancer diagnosis and treatment.
    Sabit H, Attia MG, Mohamed N, Taha PS, et al · · 2025 · cited 4× · PMID 40050490 · DOI 10.1007/s12672-025-01940-6
  2. Liquid biopsy in breast cancer: Redefining precision medicine.
    Schiavone ML, Scarpitta R, Ravera F, Bleve S, et al · · 2025 · cited 3× · PMID 40740670 · DOI 10.1016/j.jlb.2025.100312

Verify or expand the search:

Other recruiting trials for Breast Cancer Female

Currently open trials in the same condition.

Other Gene Solutions trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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