AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II Open-Label Randomized Controlled Pre-Surgical Feasibility Study of Antibiotic Combinations in Early Breast Cancer – ABC2

This study, called ABC2, is exploring new ways to treat early breast cancer in women before they have surgery. It's a Phase II study, meaning researchers are carefully testing different combinations of antibiotics to see if they can reduce the growth of cancer cells. They will compare samples of the tumour taken before and after the patients receive the antibiotics. The main goal is to see if a marker called Ki67, which shows how fast cancer cells are growing, decreases after treatment. This research could help us understand if antibiotics have a role in fighting breast cancer, potentially leading to new treatment options in the future. It's a small-scale study to see if this approach is promising enough for larger trials.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Ospedaliero Universitaria Pisana

Enrolment target

Start

19 Nov 2024

Breast Cancer

What is this study about?

Imagine your doctor tells you that you have early breast cancer. This study is looking at a new idea for treating it before you even have surgery. It's like a scientific detective story, trying to find out if certain common antibiotics, which we usually take for infections, might also help slow down breast cancer cells.

The researchers are giving specific combinations of antibiotics to women with early breast cancer for a short time before their planned surgery. They will take a small sample of the cancer cells before the treatment starts and another sample after the antibiotic treatment, but still before surgery. By comparing these samples, they can see if the antibiotics have made any difference to how quickly the cancer cells are growing. They're particularly looking at something called Ki67, which is a common way doctors measure how fast cancer cells are dividing.

This is a 'Phase II' study, which means it's an early-stage investigation. The main goal isn't to cure the cancer right now, but to see if this idea of using antibiotics against breast cancer cells shows enough promise to be studied further in bigger trials. If these antibiotics do reduce cancer cell growth, it could open up exciting new possibilities for treating breast cancer in the future.

Key takeaways

This study explores using antibiotics to slow cancer cell growth before breast cancer surgery.
It's an early-stage ('Phase II') study, looking for promising results for future research.
Participants are women aged 18 and over with early breast cancer.
The main goal is to see if antibiotic treatment reduces how fast cancer cells grow (measured by Ki67).
Taking part involves antibiotic medication and biopsies before and after treatment.
Information from this study could help develop new breast cancer treatments.

Who may be eligible?

This study is particularly looking for women who have been diagnosed with early breast cancer. To join, you need to be at least 18 years old – there's no upper age limit for taking part.

The study is focused on women because breast cancer is most common in women and this particular study is designed to gather information from female participants.

It's important to remember that this is a general guide. Many other factors are considered when deciding if someone can join a study, and these will be explained in detail by the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you at least 18 years old?
Have you been diagnosed with early breast cancer?
Are you scheduled for breast cancer surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive specific antibiotic medications (AZITROMICINA ZENTIVA, Bassado, and CEBION, which is Vitamin C) for a short period before your planned breast cancer surgery. The exact duration of this treatment would be explained to you.

Before starting the treatment, you would have a small sample (biopsy) taken from your breast cancer. Another sample would be taken after you finish the antibiotic treatment, but before your main surgery. Throughout the study, you would have regular visits to the clinic so the study team can check on your health and any side effects. There might also be follow-up appointments after your surgery to see how you are doing overall. The total duration of your active participation, including medication and assessments, would be carefully outlined by the study team.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, as this is an early-stage trial. However, the information gathered could help future patients with breast cancer by leading to new treatment options. Potential risks include experiencing side effects from the antibiotics, such as stomach upset or other reactions, which the study team will monitor closely. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy

Common questions

What is a 'Phase II' study?

A Phase II study is an early stage of research where doctors test a new treatment on a small group of people to see if it's safe and if it shows any promising signs that it works.

Why are antibiotics being tested for breast cancer?

Researchers are exploring if certain antibiotics might have properties that can slow down cancer cell growth, which could open new avenues for treatment in the future.

Will this study cure my cancer?

This study is designed to gather information and see if this approach is promising. It's not designed to be a cure, but it adds to our understanding of breast cancer treatment.

What is Ki67?

Ki67 is a marker that doctors use to measure how quickly cancer cells are dividing and growing. A lower Ki67 usually means the cells are growing slower.

Do I have to pay to be in the study?

No, you will not have to pay for the study treatments or assessments that are part of the trial. These costs are covered by the research study.