Skip to main content
OpenTrials
Completed

NCT Number: NCT00462696

MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in women receiving chemotherapy for infiltrating breast cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonie

Bordeaux, 33076, France

About this study

Pilot study (feasibility) without direct individual benefit aimed at breast cancer patients treated with neoadjuvant chemotherapy prior to local breast surgery (lumpectomy or mastectomy).

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed infiltrative breast cancer meeting 1 of the following criteria:
  • Operable T2 or T3, M0 disease
  • Locally advanced disease (T4a, b, or c)
  • No T4d disease
  • Indication for neoadjuvant chemotherapy before breast-conserving surgery
  • No desire by patient for complete mastectomy
  • No overexpression of HER-2
  • No multifocal tumor
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Life expectancy > 6 months
  • No contraindication to MRI with contrast, including any of the following:
  • Claustrophobia
  • Prior major allergies
  • Cardiac pacemaker
  • Surgical clips
  • Certain cardiac valves
  • Sunken or hollow filters
  • Implanted pump
  • Cochlear implants
  • Metallic foreign body (intra-ocular)
  • No contraindication to chemotherapy or surgery
  • No other serious condition that would preclude study therapy
  • No other uncontrolled medical condition, including any of the following:
  • Thyroid disease
  • Neuropsychiatric disease
  • Infection
  • Insufficient coronary capacity
  • NYHA class III-IV heart disease
  • No HIV positivity
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy, radiotherapy, or surgery for ipsilateral breast cancer
  • No prior biopsy of tumor before MRI
  • No MRI at another center within the past 15 days
  • No participation in another investigational study of anticancer therapy within the past 30 days

Treatment and study plan

Neoadjuvant chemotherapy

Drug

Neoadjuvant tehrapy as per standard practice :

Patients will be treated with six cycles of neoadjuvant chemotherapy combining epirubicin (75 mg/m² on day 1) and docetaxel (75 mg/m² on day 1), administered every 21 days (Delcambre, 2005; Wenzel, 1999). This treatment regimen is in line with the latest international recommendations (Kaufmann, 2003). The addition of a leukocyte growth factor in cases of grade IV leukopenia and/or treatment postponements due to grade 3-4 toxicity will be authorized with a maximum delay of 2 weeks per cycle. Dose reductions will be authorized in 25% increments for grade 3-4 toxicity

. Systematic surgical excision of the residual lesion (or the initial tumor site) will be performed between 22 and 35 days after the last chemotherapy treatment, in the form of a lumpectomy or mastectomy, depending on the residual tumor. Lymph node dissection will be systematically associated.

Primary outcomes

  1. Reproducibility of the MRI Vascular Permeability (Kep)

    Time frame: two months after start of neoadjuvant chemotherapy

    MRI vascular permeability is measured using Kep index (Rate constant between extracellular extravascular space (EES) and plasma).

    Kep index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.

  2. Reproducibility of the MRI Vascular Permeability (HA)

    Time frame: two months after start of neoadjuvant chemotherapy

    MRI vascular permeability is measured using HA index (Hepatic Artery index or Hepatic Arterial perfusion).

    HA index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer

Acronym: ISNA-Sein

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 19, 2007
Registry last updated
Oct 6, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.