Clinical trial · Observational
Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
NCT03709134CI-TRIAL-00084898completedClinicalTrials.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 primary aim of the study is to identify genomic markers (circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), transcriptomic markers) as biomarkers of response to neoadjuvant chemotherapy (NAC) among patients with invasive breast cancer.
Conditions
Conditions (3)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genomic Markers (CTC/ctDNA) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathologic complete response (pCR)
- timeFrame
- Up to 60 months
- description
- Evaluating the degree of absence of residual cancer cells
Secondary outcomes (3)
- measure
- Time to distant breast cancer recurrence (months)
- timeFrame
- Up to 60 months
- description
- Evaluating the time until a recurrence event has occurred in the breast.
- measure
- Time to any recurrence (months)
- timeFrame
- Up to 60 months
- description
- Evaluating the time until a local, regional, or distant recurrence event has occurred.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must give appropriate written informed consent prior to participation in the study. 2. Subjects must be women or men age 18+. 3. Subjects must be receiving neoadjuvant chemotherapy for breast cancer. All chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist). 4. Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-). 5. Stage I-III disease according to the AJCC v7 criteria. Exclusion Criteria: 1. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue. 2. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.
References
Publications (0)
Data not yet available
No reference posted for this study.