RecurIndex Predicts Risk of Recurrence in Early-stage Luminal Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group1 Chemotherapy+endocrine therapy+radiotherapy |
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| Group2 Chemotherapy+endocrine therapy |
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| Group3 endocrine therapy+radiotherapy |
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| Group4 endocrine therapy |
Outcome Measures
Primary Outcome Measures
- invasive disease-free survival (IDFS) [5 years]
defined as time between treatment and the time of invasive disease occurred
- recurrence free survival (RFS) [5 years]
defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Secondary Outcome Measures
- overall survival (OS) [5 years]
defined as time between treatment and the time of death occurred
- distance metastasis-free interval (DMFI) [5 years]
defined as time between treatment and the time of distant metastases, or death
- local-regional recurrence-free interval (LRFI) [5 years]
defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old, ≤ 70 years old.
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Eastern Cooperative Oncology Group (ECOG) ≤ 2.
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Postoperative pathology is clearly diagnosed as invasive breast cancer.
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Estrogen receptor (ER) or progesterone receptor (PR) positive, HER2 negative.
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Available with Formalin-Fixed and Parrffin-Embedded (FFPE) tumor tissue.
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Stage I-II patients who have received surgery (breast-conserving or mastectomy) and the pathological staging is pT1-2N0-1M0 or pT3N0M0.
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The patient had not received systemic systemic treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy) before enrollment.
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Signed an informed consent form.
Exclusion Criteria:
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Breast cancer patients whose clinical or pathological stage is T4, N2-3 or M1.
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Known human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases.
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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.
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Patients with double breast cancer.
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Severe/uncontrolled intercurrent diseases/infections.
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Subjects with allogeneic organ transplants requiring immunosuppressive therapy.
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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.
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Not suitable for hormone receptor modulators (e.g. tamoxifen) and adjuvant endocrine other drug therapy.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhejiang Cancer Hospital
Investigators
- Study Chair: Xiajia Wang, MD, Zhejiang Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZhejiangCH-0709