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New trial aims to end surgery for rare breast disease

NCT ID NCT07454772

Disease control Sponsor: All India Institute of Medical Sciences, Bhubaneswar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether antibiotics or steroids work better for granulomatous lobular mastitis, a rare inflammatory breast condition that mostly affects young women after childbirth. Seventy-two participants will receive either an 8-week course of antibiotics or tapering doses of steroids. The goal is to find which treatment leads to faster healing with fewer side effects, potentially creating a standard care plan and reducing the need for surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prednisolone (steroid) and a combination of clarithromycin, ofloxacin, and rifaximin (antibiotics)
What this could lead to
If successful, this study could establish a standard treatment protocol for granulomatous lobular mastitis, reducing the need for surgery and improving recovery for affected women.
What could go wrong
This is an early-phase trial with only 72 participants, so results may not apply to everyone. Both treatments have side effects, and some patients may not respond to either option.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women histologically diagnosed with GLM willing to participate in the study and to come for follow up. Exclusion Criteria: * Declining to participate in the study * Pregnant or lactating women * Patient already on antibiotic/steroid therapy and are responding to treatment * Known immunosuppression or diabetes mellitus uncontrolled * Patient already on immunosuppression therapy for any other disorder * Lost to follow-up before 3 months post-treatment * Allergic to one of the antibiotics/steroids which will be used * Contraindications to oral steroids therapy * Contraindications to methotrexate therapy

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Conditions

The condition(s) this trial relates to.

granulomatous mastitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Granulomatous mastitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIIMS Bhubaneswar

    Bhubaneswar, Odisha, 751019, India

More trials for these conditions

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