Evaluation of antibiotics in early breast cancer

Phase 1

• Conditions: We investigated, in a population of patients with breast cancer, the combined effect of azithrocyn, docyciclin and vitamin C on biomarkers associated with cell proliferation; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.0Level: LLTClassification code 10079328Term: Breast tumor excisionSystem Organ Class: 100000004865

• Registration Number: EUCTR2019-004074-25-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

(1) accession through informed consent; (2) WHO Performance Status 0-1; (3) ability to swallow; (4) adult females; (5) Clinical stage 1-3 AJCC; (6) planned surgical intervention in accordance with the timing of the trial; (7) normal kidney and liver function; (8) diagnosis of invasive carcinoma verified by biopsy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1) previous treatments for breast cancer or other malignancies (except malignant skin tumors other than melanoma); (2) surgical treatments or antibiotics in the 4 weeks prior to entering the trial; (3) known intolerance or allergy to the drugs being tested; (4) presence of severe or uncontrolled systemic diseases; (5) concomitant neoadjuvant therapy; (6) surgery scheduled less than two weeks after the signing of the informed consent; (7) pregnancy or breastfeeding; (8) concomitant therapies with drugs capable of interacting with Doxycycline, Azithromycin or Vitamin C; (9) inability to understand and to wish; (10) homeless patients; (11) history of abuse or dependence on alcohol and / or drugs; (12) deficiency of the enzyme glucose 6P dehydrogenase.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified