Clinical trial NCT03627988: 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.
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Invasive
Keywords: Breast Cancer Invasive
TomoTherapy
Immediate prosthetic breast reconstruction
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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. 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.

Primary outcomes:
measure: Rate of patients with successful mastectomy strategy by immediate reconstruction.
timeFrame: 12 months for each patient
Secondary outcomes:
measure: Quality of the radiotherapy treatment plan (dosimetry).
timeFrame: 78 months for all patients
measure: Progression-free survival.
timeFrame: 36 months for each patient
measure: Early complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
timeFrame: 36 months for each patient
measure: Late complications assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.03.
timeFrame: 36 months for each patient
measure: Quality of Life assessed using the questionnaire called "Breast-Q".
timeFrame: 36 months for each patient
measure: Cosmetic outcome of treated breast assessed using a questionnaire with a Likert scale.
timeFrame: 36 months for each patient
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Toulouse
country: France
facility: Institut Universitaire Du Cancer de Toulouse - Oncopole
Study officials:
References: