Clinical trial · Observational
A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer
A Observational RWS of YWBC on the Prognosis and Treatment
- 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)
This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients. We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- PFS
- timeFrame
- 5 years
- description
- The time from the first medication at the beginning of treatment to the first disease progression or death from any cause
Secondary outcomes (2)
- measure
- OS
- timeFrame
- 5 years
- description
- time from randomization to death from any cause
- measure
- ORR
- timeFrame
- 5 years
- description
- After treatment, the percentage of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit was evaluated, including complete remission (CR) + partial remission (PR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed as breast cancer. 2. The age of diagnosis was 18-35 years old. 3. ECOG score was 0-2, and the expected survival time was more than 3 months. 4. No serious complications; no liver, kidney, hematopoiesis dysfunction. 5. Informed consent, and patients willing to long-term follow-up. - Exclusion Criteria: 1. 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study. 2. Having a clear history of neurological or mental disorders (including epilepsy or dementia). 3. Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders. 4. Pregnant or lactating female patients. 5. HIV infected patients. 6. Patients with other tumors. 7. After comprehensive evaluation, the researchers believe that patients are not suitable for this study.
References
Publications (0)
Data not yet available