Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy. (MARTA)
May 19, 2026 updated by: Institut Claudius Regaud
Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy +/-Chemotherapy.
Patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study.
The study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: TomoTherapy +/-Chemotherapy (radiation therapy alone or preceded by chemotherapy).
The nature of the chemotherapy treatment will be decided according to the standards of each center.
The patients will be followed for the study up to 36 months after the surgical procedure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bordeaux, France
- Institut Bergonie
-
Toulouse, France, 31059
- Institut Universitaire du Cancer de Toulouse - Oncopole
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Patient with a non-inflammatory and non-metastatic invasive mammary carcinoma.
- Indication of mastectomy and immediate prosthetic breast reconstruction.
- Patient wishing to have an immediate mammary reconstruction with prosthesis.
- Formal or presumptive pre-operative indication for adjuvant radiotherapy (+/- chemotherapy).
- OMS ≤ 2.
- Patient affiliated to a Social Health Insurance in France.
- Patient must provide written informed consent prior to any study specific procedures.
Exclusion Criteria:
- Metastatic breast cancer.
- Bilateral breast cancer.
- Inflammatory breast cancer (T4d).
- History of breast cancer within 5 years.
- Not applicable according to the protocol version N°6 : Previous neoadjuvant treatment for the ongoing disease.
- Pregnant or breastfeeding women.
- Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
- Patient protected by law.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with breast cancer
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of patients with successful mastectomy strategy by immediate reconstruction.
Time Frame: 12 months for each patient
|
12 months for each patient
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of the radiotherapy treatment plan (dosimetry).
Time Frame: 78 months for all patients
|
78 months for all patients
|
|
Progression-free survival.
Time Frame: 36 months for each patient
|
36 months for each patient
|
|
Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Time Frame: 36 months for each patient
|
36 months for each patient
|
|
Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Time Frame: 36 months for each patient
|
36 months for each patient
|
|
Quality of Life assessed using the questionnaire called "Breast-Q".
Time Frame: 36 months for each patient
|
36 months for each patient
|
|
Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.
Time Frame: 36 months for each patient
|
36 months for each patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2019
Primary Completion (Actual)
May 18, 2026
Study Completion (Actual)
May 18, 2026
Study Registration Dates
First Submitted
August 2, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 14, 2018
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 19, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18 SEIN 11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.