Clinical trial · Interventional
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer
NCT03786575CI-TRIAL-00039163unknownN/AClinicalTrials.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)
To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast cancer. The primary endpoints were progression-free survival (PFS), and the secondary endpoints included overall survival time (OS), adverse events (AE), and severe adverse events (SAE).
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 Neoplasm Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Mutation | — | UNRESOLVED | — |
| Therapeutics | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Next Generation Sequencing (NGS) detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NGS detection group
- description
- Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated endocrine treatment plan according to the test results. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard.
- interventionNames
- Diagnostic Test: Next Generation Sequencing (NGS) detection
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- up to 36 months
- description
- From date of first use endocrine treatment until the date of first documented progression or date of death from any cause, whichever came first
Secondary outcomes (2)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years, female； 2. Pathologically and immunohistochemically confirmed ER-positive/HER-2-negative patients with advanced breast cancer； 3. According to RECIST standard, lesions can be measured (primary lesion length \> 1.0 cm or lymph node diameter \> 1.5 cm)； 4. Previous endocrine therapy resistance, preparation for second-or-above-line endocrine therapy； 5. No visceral crisis； 6. ECOG PS score: 0-2 points; 7. Laboratory criteria: ① white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more than 1.5 x 109 /L. ② platelet (\>100 \*109/L); hemoglobin (\>10g/dL); serum creatinine (\<1.5 \*normal value) upper limit (ULN); aspartate aminotransferase (AST) (\<2.5 \*ULN); alanine aminotransferase (ALT) (\<2.5 \*ULN); total bilirubin (\<1.5 \*ULN); serum creatinine (\<1.5 \*ULN); 8. the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up. Exclusion Criteria: 1. Pregnant or lactation woman 2. With mental disease 3. With severe infection or active gastrointestinal ulcers 4. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes 5. taking part or participating in other clinical trials within one month.
References
Publications (0)
Data not yet available
No reference posted for this study.