Clinical trial · Interventional
The Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
A Randomized Multi-center Phase III Study About the Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.
NCT02942615CI-TRIAL-00062931unknownN/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)
This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| limit heart dose | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Heart safety management
- description
- limit heart dose more frequent follow up of cardiac function professional management of cardiac toxicity
- interventionNames
- Other: limit heart dose
- type
- NO_INTERVENTION
- label
- Control group
- description
- without any restrict heart dose limitation for RT Follow up of cardiac function Observation and without any special management of cardiac toxicity
Primary outcomes (1)
- measure
- cardiac toxicity event free survival
- timeFrame
- 1 year
- description
- The time from the date of randomization to any recurrence of clinical or subclinical cardiac toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients willing to participate the research and sign the informed consent file; * Patients aged 18-80 years; * KPS≥70; * Pathological diagnosis for invasive breast cancer; * Patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy; * No functional heart disease; * LVEF≥50%; * Patients received breast conserving surgery; * Patients received modified radical mastectomy: T1-2 with N1-3 or T3-4 with any N; * Tumor margin negative; * No metastases; * No other malignant tumor history. Exclusion Criteria: * Patients with metastases; * Tumor margin positive; * Patients received modified radical mastectomy with T1-2 and N0; * Patients have other malignant tumor; * Patients have a history of heart disease; * Patients received chest radiotherapy previously; * Patients with severe organic and functional disease; * Unqualified patients with sufficient reasons; * Cannot or no willing to sign the informed consent file; * Patients with autoimmune disease; * Women with pregnancy, planned pregnancy or lactating.
References
Publications (1)
- DERIVEDCao L, Ou D, Qi WX, Xu C, Ye M, Fang YH, Shi M, Huang XB, Lin Q, Liu T, Cai G, Cai R, Chen M, Zhang YB, Su XX, Qian XF, Shen KW, Chen JY. A randomized trial of early cardiotoxicity in breast cancer patients receiving postoperative IMRT with or without serial cardiac dose constraints. Int J Cancer. 2025 Mar 15;156(6):1213-1224. doi: 10.1002/ijc.35245. Epub 2024 Nov 5. PMID 39499199