Clinical trial · Observational
RecurIndex Predicts Risk of Recurrence in Early-stage Luminal Breast Cancer
A Clinical Translational Study on the Multi-gene Assays and RecurIndex for Predicting the Breast Cancer Recurrence Risk in Cross-strait Chinese Patients With Early-stage Luminal Breast Cancer
- 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 study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. The aim of this study is to validate the predictive effect of the RecurIndex on the risk of recurrence in women with early-stage Luminal-type breast cancer in China.
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 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Group1
- description
- Chemotherapy+endocrine therapy+radiotherapy
- label
- Group2
- description
- Chemotherapy+endocrine therapy
- label
- Group3
- description
- endocrine therapy+radiotherapy
- label
- Group4
- description
- endocrine therapy
Primary outcomes (2)
- measure
- invasive disease-free survival (IDFS)
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old, ≤ 70 years old. * Eastern Cooperative Oncology Group (ECOG) ≤ 2. * Postoperative pathology is clearly diagnosed as invasive breast cancer. * Estrogen receptor (ER) or progesterone receptor (PR) positive, HER2 negative. * Available with Formalin-Fixed and Parrffin-Embedded (FFPE) tumor tissue. * Stage I-II patients who have received surgery (breast-conserving or mastectomy) and the pathological staging is pT1-2N0-1M0 or pT3N0M0. * The patient had not received systemic systemic treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy) before enrollment. * Signed an informed consent form. Exclusion Criteria: * Breast cancer patients whose clinical or pathological stage is T4, N2-3 or M1. * Known human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases. * Other psychiatric disorders that may interfere with the judgment of the study results, or abnormal laboratory tests; and who, in the judgment of the investigator, are considered unfit to participate in the study. * Patients with double breast cancer. * Severe/uncontrolled intercurrent diseases/infections. * Subjects with allogeneic organ transplants requiring immunosuppressive therapy. * Hormone receptors ER and PR are negative (any detectable estrogen and progesterone receptors do not express or express \<1%) and/or HER2 overexpression/amplified by FISH detection. * Not suitable for hormone receptor modulators (e.g. tamoxifen) and adjuvant endocrine other drug therapy.
References
Publications (0)
Data not yet available