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)

  • STATUS
    Recruiting
  • End date
    Dec 20, 2025
  • participants needed
    55
  • sponsor
    Institut Claudius Regaud
Updated on 20 April 2022
carcinoma
mastectomy

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.

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.

Details
Condition Breast Cancer Invasive
Treatment Patients with invasive breast cancer will receive:
Clinical Study IdentifierNCT03627988
SponsorInstitut Claudius Regaud
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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