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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)

Primary Purpose

Breast Cancer Invasive

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Patients with invasive breast cancer will receive:
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer Invasive focused on measuring Breast Cancer Invasive, TomoTherapy, Immediate prosthetic breast reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. 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:

  1. Metastatic breast cancer.
  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.

Sites / Locations

  • Institut Bergonie
  • Institut Universitaire Du Cancer de Toulouse - Oncopole

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with breast cancer

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients with successful mastectomy strategy by immediate reconstruction.

Secondary Outcome Measures

Quality of the radiotherapy treatment plan (dosimetry).
Progression-free survival.
Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
Quality of Life assessed using the questionnaire called "Breast-Q".
Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.

Full Information

First Posted
August 2, 2018
Last Updated
June 12, 2023
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT03627988
Brief 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.
Acronym
MARTA
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Invasive
Keywords
Breast Cancer Invasive, TomoTherapy, Immediate prosthetic breast reconstruction

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with breast cancer
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patients with invasive breast cancer will receive:
Intervention Description
Mastectomy with Immediate prosthetic breast reconstruction Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).
Primary Outcome Measure Information:
Title
Rate of patients with successful mastectomy strategy by immediate reconstruction.
Time Frame
12 months for each patient
Secondary Outcome Measure Information:
Title
Quality of the radiotherapy treatment plan (dosimetry).
Time Frame
78 months for all patients
Title
Progression-free survival.
Time Frame
36 months for each patient
Title
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
Title
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
Title
Quality of Life assessed using the questionnaire called "Breast-Q".
Time Frame
36 months for each patient
Title
Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.
Time Frame
36 months for each patient

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Facility Name
Institut Universitaire Du Cancer de Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Learn more about this trial

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.

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