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NCT Number: 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.

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.

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Key information

Conditions

Breast Cancer Invasive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonie, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy

Procedure
  • Mastectomy with Immediate prosthetic breast reconstruction
  • Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy).

Primary outcomes

  1. Rate of patients with successful mastectomy strategy by immediate reconstruction.

    Time frame: 12 months for each patient

Secondary outcomes

  1. Quality of the radiotherapy treatment plan (dosimetry).

    Time frame: 78 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

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: MARTA

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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