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Study of Azithromycin, Doxycycline, and Sodium Ascorbate for Patients with Early-Stage Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of certain antibiotic combinations in patients with early breast cancer. The antibiotics being tested include azithromycin, doxycycline, and a form of vitamin C known as sodium ascorbate. The purpose of the study is to see if a short-term treatment with these antibiotics before surgery can help reduce the growth of cancer cells in the breast.

Participants in the study will take these medications orally for a period of up to two weeks before their scheduled breast surgery. The study aims to observe any changes in the cancer cells by comparing samples taken before and after the treatment. This will help researchers understand if the antibiotics can slow down or stop the cancer cells from multiplying.

The trial includes patients with different types of early-stage breast cancer, specifically those in stages I to III. By examining the effects of these antibiotics, the study hopes to find new ways to manage breast cancer before surgery. The results could provide valuable insights into how these medications might be used to improve treatment outcomes for breast cancer patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient provides written informed consent. This confirms understanding and agreement to participate in the trial.
Eligibility is confirmed based on criteria such as age, health status, and diagnosis of early-stage breast cancer.
Step 2
Medication administration
The patient begins a two-week treatment with a combination of antibiotics taken orally. The medications include Azithromycin (500 mg film-coated tablet), Doxycycline (100 mg tablet), and Sodium Ascorbate (chewable tablet).
The specific dosage and frequency of each medication are determined by the study protocol and are administered as prescribed.
Step 3
Monitoring and assessment
Throughout the treatment period, the patient is monitored for any side effects or changes in health status.
Regular assessments are conducted to evaluate the impact of the medication on tumor markers, specifically the Ki67 protein, which is associated with cell proliferation.
Step 4
Surgical procedure
After completing the two-week medication regimen, the patient undergoes a scheduled surgical procedure to remove the breast tumor.
Post-surgery, the tumor tissue is analyzed to measure changes in the Ki67 protein levels compared to pre-treatment levels.
Step 5
Follow-up
Following surgery, the patient attends follow-up appointments to monitor recovery and assess the long-term effects of the treatment.
The study aims to determine the effectiveness of the antibiotic combination in reducing tumor proliferation markers.

Who can join the trial?

9 criteria

Provide written agreement to participate in the study.
Have a World Health Organization (WHO) performance status of 0-1, which means being fully active or having some symptoms but being able to carry out light work, with no worsening in the last 2 weeks.
Be able to swallow and keep oral medication in the body.
Be a female over 18 years old with confirmed invasive breast cancer through a tissue sample.
Have breast cancer at AJCC Stage 1-2 or Stage 3, which means early to locally advanced stages, and be a candidate for primary surgery.
Be scheduled for definitive breast surgery at least two weeks after joining the study.
Have kidney and liver function tests within 10% of normal laboratory limits.
Have a diagnostic biopsy, which is a small sample of tissue taken to check for cancer.
Women who can have children can join, but using oral contraceptives, being pregnant, or breastfeeding will exclude them from the study.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with breast cancer cannot participate. This study is specifically for those with breast cancer.
Only patients with early-stage breast cancer, specifically stages I to III, are eligible. Those with more advanced stages are excluded.
Participants must be female, as the study does not include male subjects.
Patients who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.
Participants must be within the specified age range for the study. Those outside this range cannot participate.

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Universita' Di Pisa
Pisa, Italy

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Investigated drugs

Doxycycline
is an antibiotic used in this trial to see if it can help reduce the growth of breast cancer cells before surgery. It is part of a combination treatment aimed at decreasing tumor activity.
Amoxicillin
is another antibiotic included in the study. It is used alongside other medications to test its effectiveness in slowing down the proliferation of cancer cells in patients with early-stage breast cancer.
Vancomycin
is the third antibiotic in the combination being tested. This medication is used to see if it can contribute to reducing the activity of breast cancer cells when given before surgery.

What is already known about the treatment

DAV Combination – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating early-stage breast cancer. The main therapeutic indication is to reduce tumor proliferation markers in patients with stage I to III breast cancer. The mechanism of action involves inhibiting tumor cell growth, as measured by a decrease in the Ki67 protein, which is a marker of cell proliferation. It falls under the pharmacological classification of antibiotics, although its specific role in cancer treatment is still under investigation.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some tumors growing slowly and others more rapidly. It is classified into stages based on the size of the tumor and whether it has spread to lymph nodes or other areas. Breast cancer can affect both men and women, though it is much more common in women. Various subtypes exist, each with different characteristics and growth patterns.