Breast Cancer InvasivePhase 2MARTANCT03627988
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.
A Phase 2 study testing Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy in people with Breast Cancer Invasive, run by Institut Claudius Regaud at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Jun 2019to 18 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Bergonie
Bordeaux
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
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.
Read more
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.
- Conditions
- Breast Cancer Invasive
- Being tested
- Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy
- Keywords
- Breast Cancer Invasive, TomoTherapy, Immediate prosthetic breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapyProcedure or surgery
- Mastectomy with Immediate prosthetic breast reconstruction
- Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer | Experimental | Not described Receives: Procedure: Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with successful mastectomy strategy by immediate reconstruction.
Measured: 12 months for each patient
Secondary outcomes (6)
Quality of the radiotherapy treatment plan (dosimetry).
Measured: 78 months for all patients
Progression-free survival.
Measured: 36 months for each patient
Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Measured: 36 months for each patient
Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Measured: 36 months for each patient
Quality of Life assessed using the questionnaire called "Breast-Q".
Measured: 36 months for each patient
Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.
Measured: 36 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start7 Jun 2019
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627988
- Sponsor's protocol ID
- 18 SEIN 11
- Acronym
- MARTA
- Status last verified
- May 2026
- First submitted
- 2 Aug 2018
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03627988
- Acronym / sponsor ID
- MARTA / 18 SEIN 11
- Conditions
- Breast Cancer Invasive
- Keywords
- Breast Cancer Invasive, TomoTherapy, Immediate prosthetic breast reconstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer | Experimental | Procedure: Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy* Mastectomy with Immediate prosthetic breast reconstruction * Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy). | Procedure or surgery | Patients with breast cancer |
Primary outcome
Rate of patients with successful mastectomy strategy by immediate reconstruction.
Time frame: 12 months for each patient
6 secondary outcomes
Quality of the radiotherapy treatment plan (dosimetry).
Time frame: 78 months for all patients
Progression-free survival.
Time frame: 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
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
Quality of Life assessed using the questionnaire called "Breast-Q".
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy in people with Breast Cancer Invasive, run by Institut Claudius Regaud at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with successful mastectomy strategy by immediate reconstruction. (time frame: 12 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.