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.
NCT ID: NCT03627988
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
65 participants
INTERVENTIONAL
2019-06-07
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with breast cancer
Patients with invasive breast cancer will receive:
* Mastectomy with Immediate prosthetic breast reconstruction
* Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).
Interventions
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Patients with invasive breast cancer will receive:
* Mastectomy with Immediate prosthetic breast reconstruction
* Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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Institut Bergonie
Bordeaux, , France
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, , France
Countries
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Other Identifiers
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18 SEIN 11
Identifier Type: -
Identifier Source: org_study_id
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