Clinical trial · Interventional
Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)
NCT01289353CI-TRIAL-00049360completedPhase 1 / Phase 2Results postedClinicalTrials.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)
The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-RT or IMRT | Radiation | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ChemoRT
- description
- Concurrent Carboplatin and Radiotherapy
- interventionNames
- Drug: Carboplatin
- Radiation: 3D-RT or IMRT
Primary outcomes (1)
- measure
- Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT
- timeFrame
- 60 days post-RT
Secondary outcomes (2)
- measure
- Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)
- timeFrame
- 6 months to 5 year post-RT
- description
- Acute Toxicities include all Grade 1 toxicities
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age older than 18 * Pre- or post-menopausal women with Stage I and II breast cancer, triple negative tumors * Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (Tumors \< 5 mm in size do not require nodal assessment) or after mastectomy * No previous chemotherapy * Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document Exclusion Criteria: * Previous radiation therapy to the ipsilateral breast * Active connective tissue disorders, such as lupus or scleroderma * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.