Phase 2
Completed N=92
Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
Source: ClinicalTrials.gov NCT01289353 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT — 8 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT |
8 | — |
| SECONDARY Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) |
67 | — |
| SECONDARY Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) |
18 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01289353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.