Improvement of pathological complete response in patients with triple-negative breast cancer through IL-6 pathway inhibition and chemotherapy. Cancer
Conditions
Interventions
This investigator-initiated, prospective, open-label, non-randomized single-arm phase I/II clinical trial will evaluate the neoadjuvant sequential administration of tocilizumab followed by cisplatin/d
Sponsors
King Faisal Specialist Hospital & Research Centre
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed invasive ductal carcinoma of the breast, triple negative in subtype 2. Age 18- 65 years old 3. ECOG performance status = 1 4. Clinical tumor size: = 4 cm, T2-4 5. Clinical Nodal status: N0-3 6. No evidence of metastatic disease 7. Triple negative breast cancer (estrogen receptor (ER) negative, progesterone receptor (PR) negative and Her2/neu negative) 8. Adequate hematologic, cardiac, hepatic and renal function 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Male breast cancer 3. Women of childbearing potential unless surgically sterile or using adequate measures of contraception 4. Evidence of metastasis 5. Previous treatment with chemotherapy 6. Pervious radiotherapy or major surgery for any malignancy 7. Previous or concomitant malignancy of any type, except adequately treated basal cell carcinoma of the skin or in situ cervix cancer 8. Any of the following abnormal baseline hematological values: ANC 1.25 xULN (upper limit of normal), AST, ALT or ALP >1.25 x ULN (upper limit of normal) 10. Other serious illness or medical condition including: 10.1. History of documented congestive heart failure, angina requiring antianginal medication, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mmHg or diastolic >100mmHg, however patients with hypertension who is well controlled on medication are eligible), clinically significant valvular heart disease, or high risk uncontrolled arrhythmias 10.2. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigators to be clinically significant precluding informed consent or adversely affecting the compliance to study drugs 10.3. Serious uncontrolled infections (bacterial, viral or fungal) or poorly controlled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR), both in breast and axilla, measured via the clinical response with a physical examination using a caliper at each follow up before each treatment cycle; results will be defined as complete response, partial response, and progressive disease. Once the patients will undergo surgery, pCR will be defined as a complete absence of viable invasive tumor cells in the breast and axillary nodes, including surgical margins without ductal carcinoma in situ (ypT0/ypN0) according to NSABP B-18.21 RCB will be scored for all patients using Symmans criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall clinical response rate, including complete and partial response rates, will be measured using the RECIST criteria at the end of neoadjuvant treatment 2. Safety of the treatment, will be assessed using the CTCAE criteria at regular intervals throughout treatment and follow-up 3. The proportion of patients undergoing breast-conserving surgery, will be determined based on surgical reports at the time of surgery 4. Disease-free survival rate (loco-regional and distant), will be measured using clinical and radiological assessment over the follow-up period | — |
Countries
Saudi Arabia
Contacts
Public ContactAbdelilah Aboussekhra
Outcome results
None listed