Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo approach for breast cancer: reconstruction and radiation together

NCT ID NCT03627988

Disease control Sponsor: Institut Claudius Regaud 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study looked at women with invasive breast cancer who had a mastectomy with immediate prosthetic breast reconstruction, followed by TomoTherapy (a type of radiation) with or without chemotherapy. The goal was to see how often the reconstruction was successful. 66 patients were followed for up to 3 years. The study measured success rates, treatment quality, and side effects.

What this could mean

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

Active substance
Mastectomy with immediate prosthetic breast reconstruction and TomoTherapy radiation
What this could lead to
If successful, this approach could offer a safe and effective way to combine breast reconstruction with radiation therapy after mastectomy, improving cosmetic outcomes without delaying cancer treatment.
What could go wrong
This is a small, non-randomized phase 2 study with only 66 participants, so results may not apply to everyone. Complications from surgery or radiation, such as infection or implant issues, are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Jun 2019

Finished

May 2026

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

18 years and older

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: 1. Age ≥ 18 years. 2. Patient with a non-inflammatory and non-metastatic invasive mammary carcinoma. 3. Indication of mastectomy and immediate prosthetic breast reconstruction. 4. Patient wishing to have an immediate mammary reconstruction with prosthesis. 5. Formal or presumptive pre-operative indication for adjuvant radiotherapy (+/- chemotherapy). 6. OMS ≤ 2. 7. Patient affiliated to a Social Health Insurance in France. 8. Patient must provide written informed consent prior to any study specific procedures. Exclusion Criteria: 1. Metastatic breast cancer. 2. Bilateral breast cancer. 3. Inflammatory breast cancer (T4d). 4. History of breast cancer within 5 years. 5. Not applicable according to the protocol version N°6 : Previous neoadjuvant treatment for the ongoing disease. 6. Pregnant or breastfeeding women. 7. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure. 8. Patient protected by law.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer invasive are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer invasive

Contacts and locations

Locations

  • Institut Bergonie

    Bordeaux, France

  • Institut Universitaire Du Cancer de Toulouse - Oncopole

    Toulouse, 31059, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.