Clinical trial · Observational
Breast Cancer Liquid Biopsy Trial
Liquid vs Tissue Biopsy Concordance in Samples of 1st Suspected BCa Recurrence/Metastasis and Evaluation of DefineMBC Comprehensive Cancer Profiling Liquid Biopsy LDT
NCT04962529CI-TRIAL-00060262unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draw | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm 1: Metastatic Breast Cancer Patients With Contemporaneous Tissue Biopsy
- description
- Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI If a tissue biopsy is performed, the matched tissue will be sent to the central pathology lab for reanalysis. If a tissue biopsy was performed, but the tissue block is exhausted or unavailable, patients are still eligible to participate in the study.
- interventionNames
- Procedure: Blood Draw
- label
- Arm 2: Metastatic Breast Cancer Patients Without Contemporaneous Tissue Biopsy
- description
- Investigators plan to enroll patients previously diagnosed with a primary breast cancer of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram or MRI. A contemporaneous tissue biopsy is optional for this cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Arm 1 Inclusion criteria: * All subjects must be capable of providing informed consent * Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis. o Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment * Subjects must have suspected recurrent metastatic BC or MBC with clinical signs of progression that will be confirmed/evaluated by tissue biopsy that is expected to yield tissue adequate for histologic examination. Note that patients presenting with de novo metastasis are eligible provided a tissue biopsy meets the above criteria. * Tissue biopsy of a suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study. * The suspected metastases biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas. * In those with suspected metastases in contralateral axilla, infra/supraclavicular areas, only a new contralateral breast primary must be excluded by imaging. * No history of any other cancers (except for non-melanoma skin cancer) * Ability to access 3-month outcome data (de-identified, consented patients included for second draw at 3-month timepoint or within 14 days for the first post-treatment imaging, whichever comes first). * Data from contemporaneous diagnosis (metastatic recurrence or de novo) and in applicable past diagnosis (primary) must be accessible, including a pathology report that details standard markers and morphology describing how malignancy/cancer of origin was determined. Arm 1 Exclusion Criteria: * Unable to provide informed consent * New treatment commences prior to liquid biopsy blood collection * Previous history of an invasive non-breast cancer (except for non-melanoma skin cancer) * Subjects not undergoing a tissue biopsy at time of blood draw (for suspected breast cancer recurrence or prior to beginning new line of metastatic treatment) * Subjects with only a new contralateral breast primary tumor Arm 2 Inclusion criteria: * Capable of providing informed consent * Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis. * Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment * The suspected metastasis biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas. * In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only, a new contralateral breast primary must be excluded by imaging. * Confirmation of progression of MBC must be confirmed by imaging * (Optional) Tissue biopsy of suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study. * No history of any other cancers (except for non-melanoma skin cancer) * Data from primary BCa diagnosis must be accessible, including detailed description with standard markers and morphology describing how malignancy/cancer of origin was determined. * Subject must exhibit clinical signs of breast cancer recurrence or progression of previously confirmed metastatic breast cancer Arm 2 Exclusion Criteria: * Subjects unable to provide informed consent * New treatment regimen commences prior to liquid biopsy blood collection * Subjects on treatment for MBC with no imaging evidence of clinical progression * Previous history of an invasive non-BC apart from cancers treated with curative intent at least five (5) years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer
References
Publications (0)
Data not yet available
No reference posted for this study.