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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)

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ClinicalTrials.gov Identifier: NCT03627988
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Invasive Other: Patients with invasive breast cancer will receive: Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with breast cancer Other: Patients with invasive breast cancer will receive:
  • Total mastectomy with Immediate prosthetic breast reconstruction
  • Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).




Primary Outcome Measures :
  1. Rate of patients with successful mastectomy strategy by immediate reconstruction. [ Time Frame: 12 months for each patient ]

Secondary Outcome Measures :
  1. Quality of the radiotherapy treatment plan (dosimetry). [ Time Frame: 60 months for all patients ]
  2. Progression-free survival. [ Time Frame: 36 months for each patient ]
  3. 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 ]
  4. 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 ]
  5. Quality of Life assessed using the questionnaire called "Breast-Q". [ Time Frame: 36 months for each patient ]
  6. Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale. [ Time Frame: 36 months for each patient ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. Pre-operative indication of an 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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627988


Contacts
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Contact: Carole MASSABEAU, MD 05 31 15 54 09 massabeau.carole@iuct-oncopole.fr

Locations
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France
Institut Bergonie Recruiting
Bordeaux, France
Contact: Hélène CHARITANSKY    05 56 33 78 57    h.charitansky@bordeaux.unicancer.fr   
Institut Universitaire Du Cancer de Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Carole MASSABEAU, MD    05 31 15 54 09    massabeau.carole@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03627988    
Other Study ID Numbers: 18 SEIN 11
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Breast Cancer Invasive
TomoTherapy
Immediate prosthetic breast reconstruction
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases