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.

Breast Cancer Invasive Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03627988
• Other study ID #: 18 SEIN 11
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 7, 2019
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Breast Neoplasms

Intervention

Other:
• Patients with invasive breast cancer will receive:
Mastectomy with Immediate prosthetic breast reconstruction Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	Institut Universitaire Du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with successful mastectomy strategy by immediate reconstruction.		12 months for each patient
Secondary	Quality of the radiotherapy treatment plan (dosimetry).		78 months for all patients
Secondary	Progression-free survival.		36 months for each patient
Secondary	Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.		36 months for each patient
Secondary	Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.		36 months for each patient
Secondary	Quality of Life assessed using the questionnaire called "Breast-Q".		36 months for each patient
Secondary	Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.		36 months for each patient