so della doxiciclina nel trattamento del tumore al seno in stadio precoce

Phase 1

• Conditions: Breast cancer - Stage 1-2 to or Stage 3 that is candidate for primary surgery; MedDRA version: 20.0Level: LLTClassification code 10006213Term: Breast carcinoma stage ISystem Organ Class: 100000004864; MedDRA version: 20.1Level: LLTClassification code 10006215Term: Breast carcinoma stage IIISystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10006214Term: Breast carcinoma stage IISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000871-26-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: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

1.Provision of written informed consent.
2.World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks
3.Patients must be able to swallow and retain oral medication
4.Female patients, age over 18, with histological confirmation of invasive breast carcinoma
5.AJCC Stage 1-2 or Stage 3 that is candidate for primary surgery
6.Scheduled to have definitive breast surgery two or more weeks after study entry
7.Renal and liver biochemistry within 10% of laboratory normal limits
8.Presence of diagnostic 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Subjects cannot be homeless persons
2.Subjects cannot have active drug/alcohol dependence or abuse history
3.Subject cannot have prior treatment for breast or other cancer (excluding non-melanoma skin cancer)
4.Subject cannot have major surgery or antibiotic therapy within 4 weeks before the first dose of study treatment
5.Subject cannot have known allergy to antibiotics
6.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.
7.No other concomitant neoadjuvant breast cancer therapy (for example Tamoxifen, aromatase inhibitors, chemotherapy or Trastuzumab)
8.Less than 2 weeks from the time the subject signs the informed consent and the day of the curative surgery for invasive breast cancer.
9.Pregnancy and breast feeding are absolute contraindications.
10.Known intolerance/allergy to the drug or excipients will be an additional exclusion criterium.
11.Concomitant treatment with drugs known to interact with doxycycline (i.e., antacids, penicillins, oral antocoagulants, antiepileptics, oral contraceptives, cyclosporine, and others listed in the technical note of doxycycline) will be an exclusion criterium.
12.Obstructive disorders of the oesophagus.
13.Inability to give the informed consent.

Study & Design

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