Phase 1
Completed N=9
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer
Anatomic Stage 0 Breast Cancer AJCC v8 · Anatomic Stage I Breast Cancer AJCC v8 · Anatomic Stage IA Breast Cancer AJCC v8 · Anatomic Stage IB Breast Cancer AJCC v8
Source: ClinicalTrials.gov NCT04081389 ↗
Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Sep 2023
Primary outcomePrimary: Number of Patients With Dose Limiting Toxicities — 0; 0; 0; 0 Participants
Summary
This phase I trial studies how well chemokine modulation therapy and standard chemotherapy given before surgery work in treating patients with early stage triple negative breast cancer. Chemokine modulation therapy, including celecoxib, recombinant interferon alfa-2b, and rintatolimod, may stimulate the immune system and stop tumor cells from growing. Drugs used in standard chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemokine modulation therapy together with standard chemotherapy may work better than giving either therapy alone in treating patients with triple negative breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dose Limiting Toxicities |
0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Pathological Complete Response (pCR) |
0; 1; 2; 2 | — |
| SECONDARY Residual Cancer Burden Index |
0; 1; 2; 2; 0; 0 | — |
| SECONDARY Recurrence-free Survival (RFS) |
12.0; NA; 11.4; 11.5 | — |
| SECONDARY Overall Survival (OS) |
21.7; NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Have pathologically confirmed diagnosis of resectable triple negative breast cancer (ASCO/CAP guidelines will be used to define triple negative breast cancer)
- Must have measurable disease. Multi-centric disease is allowed. If patient has another lesion which is biopsied with ER/PR positive it will be Physician discretion for this eligibility criteria.
- Prior therapy: No prior cytotoxic regimens are allowed for this malignancy. Participants may not have had prior chemotherapy, other targeted anticancer therapies, or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
- Patient eligible for surgery as determined by patient's surgeon
- Patient must have a lesion that amendable to biopsy, unless inaccessible and with PI approval
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of = = 100,000/uL
- Hemoglobin >= 9 g/dL
- Absolute neutrophil count (ANC) >= 1500/uL
- Total bilirubin = = 50 mL/min per Cockcroft-Gault equation for patients with creatinine levels greater than ULN
- Left ventricular ejection fraction (LVEF) >= 55%; if LVEF is 6 months may be allowed after consultation with PI)
- Cardiac risk factors including:
- Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent
- Patients with a New York Heart Association classification of III or IV
- History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years
- Prior allergic reaction or hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) or any drugs administered on protocol
- Any history of allergy to sulfonamides
- Any history of autoimmune hepatitis
- Grade 1 or higher neuropathy
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Data sourced from ClinicalTrials.gov (NCT04081389). 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.