Azithromycin dihydrate for Breast cancer | Early breast cancer

Inclusion criteria

• {"criterion_text":"- 1. Provision of written informed consent\n- 2. World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks\n- 3. Patients must be able to swallow and retain oral medication\n- 4. Female patients, age over 18, with histological confirmation of invasive breast carcinoma\n- 5. AJCC Stage 1-2 or Stage 3 that is candidate for primary surgery\n- 6. Patients scheduled to have definitive breast surgery two or more weeks after study entry\n- 7. Renal and liver biochemistry within 10% of laboratory normal limits\n- 8. Presence of diagnostic biopsy. Women of childbearing potential will be enrolled, BUT the administration of oral contraceptive, pregnancy or breast feeding will be exclusion criteria (see below “Exclusion criteria”)."}

Exclusion criteria

• {"criterion_text":"- 1. Subject cannot have prior treatment for breast or other cancer (excluding non-melanoma skin cancer)\n- 2. Subject cannot have had major surgery or antibiotic therapy within 4 weeks before the first dose of study treatment\n- 3. Known poor tolerability/allergy to the study drugs (doxycycline, azithromycin or vitamin C) or excipients\n- 4. As judged by the Investigator, no evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n- 5. No other concomitant neoadjuvant breast cancer therapy (for example tamoxifen, aromatase inhibitors, chemotherapy or trastuzumab)\n- 6. Less than 2 weeks from the time the subject signs the informed consent and the day of the curative surgery for invasive breast cancer.\n- 7. Pregnancy and/or breast feeding\n- 8. Concomitant treatment with drugs known to interact with doxycycline (i.e., antacids, penicillins, oral anticoagulants, antiepileptics, oral contraceptives, cyclosporine, and others listed in the technical note of doxycycline) or azithromycin (pimozide, colchicine, fidaxomicin, ticagrelor and others listed in the technical note of azithromycin) or vitamin C (deferiprone, deferoxamine, warfarin, phenothiazine, and iron)\n- 9. Known cardiological risk factors, as Long QT interval, low blood levels of potassium and magnesium, bradycardia, concomitant treatment with antiarrhythmic drugs (listed in the technical note of azithromycin), or arrhythmias.\n- 10. Inability to give the informed consent\n- 11. Subjects cannot be homeless persons\n- 12. Subjects cannot have active drug/alcohol dependence or abuse history\n- 13. Individual clinical history for favism [glucose-6-phosphate dehydrogenase (G6PD) deficiency] as judged by family doctor’s file."}

Primary endpoints

• {"endpoint_text":"- Reduction in Ki67 expression in post-treatment tumor core biopsies compared to pre-treatment tumor core biopsies (from the same patient). Post-treatment samples will also be compared with untreated samples.","definition_or_measurement_approach":"Comparison of Ki67 expression in post-treatment tumor core biopsies versus pre-treatment tumor core biopsies from the same patient; post-treatment samples additionally compared with untreated samples. (Measurement of tumor Ki67 as a marker of proliferation.)"}

Italy

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

19-11-2024

Processing Time Days

49

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Pisana

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy