Study of Antibiotic Combinations in Early Breast Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero Universitaria Pisana

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-11-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Lunella Biotech

External identifiers

EU CT number

2024-517993-94-00

EudraCT number

2019-004074-25

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine whether short-term (2 weeks) pre-operative treatment with oral DAV combination 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). All breast cancer subtypes will be included.

Conditions and MedDRA coding

Breast Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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. Patients 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. 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 1

1. 1. Subject cannot have prior treatment for breast or other cancer (excluding non-melanoma skin cancer) 2. Subject cannot have had major surgery or antibiotic therapy within 4 weeks before the first dose of study treatment 3. Known poor tolerability/allergy to the study drugs (doxycycline, azithromycin or vitamin C) or excipients 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. 5. No other concomitant neoadjuvant breast cancer therapy (for example tamoxifen, aromatase inhibitors, chemotherapy or trastuzumab) 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. 7. Pregnancy and/or breast feeding 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) 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. 10. Inability to give the informed consent 11. Subjects cannot be homeless persons 12. Subjects cannot have active drug/alcohol dependence or abuse history 13. Individual clinical history for favism [glucose-6-phosphate dehydrogenase (G6PD) deficiency] as judged by family doctor’s file.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero Universitaria Pisana

Sponsor organisation

Azienda Ospedaliero Universitaria Pisana

Address

Via Roma 67

City

Pisa

Postcode

56126

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero Universitaria Pisana

Contact name

Clinical Trial Center

Public contact point

Organisation

Azienda Ospedaliero Universitaria Pisana

Contact name

Clinical Trial Center

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications