Breast cancer - Stage 1-2 to or Stage 3 that is candidate for primary surgery MedDRA version: 20.0 Level: LLT Classification code 10006213 Term: Breast carcinoma stage I System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10006215 Term: Breast carcinoma stage III System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10006214 Term: Breast carcinoma stage II System Organ Class: 100000004864
Conditions
Interventions
Trade Name: BASSADO - 100 MG COMPRESSE 10 COMPRESSE
Product Name: BASSADO
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: DOXICICLINA ICLATO
CAS Number: 564-25-0
Current Sponsor code
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether short-term (2 weeks) pre-operative treatment with oral doxycycline of stage I-to-III early breast cancer patients results in inhibition of tumor proliferation markers, as determined by a reduction in tumor Ki67 from baseline (pre-treatment) to post-treatment (at time of surgical excision);Secondary Objective: In tumour tissue collected at the time of diagnosis (biopsy) and at the surgical excision of the neoplasm, before and after doxycycline administration, the following objectives will be pursued: oEvaluation of markers of cell proliferation, apoptosis, p27, angiogenesis (CD31), stem cells (markers ALDH, CD44/24), mitochondria (TOMM20). oIn primary tumour culture, the formation of mammosphere will be evaluated, along with their molecular status and response to doxycycline. Moreover, the following secondary objectives will be taken into account: ¿Doxycycline pharmacokinetics ¿Treatment safety;Primary end point(s): Ki67 evaluation;Timepoint(s) of evaluation of this end point: Before (diagnostic biopsy) and after doxycycline administration (surgically-excissed tumour tissue) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of markers predictive of: - apoptosis; - cell cycle inhibition (p27) - angiogenesis (CD31) - stem cells (ALDH, CD44/24) - mitochondria (TOMM20) -mammosphere formation from primary culture of patients¿ neoplastic tissues - molecular status (genetic profile) and effects of doxycycline - tissue and plasma concentrations of doxycycline - safety;Timepoint(s) of evaluation of this end point: Before (diagnostic biopsy) and after doxycycline administration (surgically-excissed tumour tissue) | — |
Countries
Italy
Contacts
Public ContactU.O. Senologia
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Outcome results
None listed