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.

Phase 2

Active, not recruiting

• Conditions: Breast Cancer Invasive

• Registration Number: NCT03627988
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-14
• Study Start: 2019-06-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of patients with successful mastectomy strategy by immediate reconstruction.	12 months for each patient

Secondary Outcome Measures

Name	Time	Method
Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.	36 months for each patient
Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.	36 months for each patient
Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.	36 months for each patient
Quality of the radiotherapy treatment plan (dosimetry).	78 months for all patients
Progression-free survival.	36 months for each patient
Quality of Life assessed using the questionnaire called "Breast-Q".	36 months for each patient

Trial Locations

Locations (2)

Institut Bergonie; 🇫🇷 Bordeaux, France

Institut Universitaire Du Cancer de Toulouse - Oncopole; 🇫🇷 Toulouse, France