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

18 Years
70 Years
Not Enrolling
Breast Cancer

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Trial Information

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



- Evaluate the feasibility (reproducibility and repeatability) of MRI for assessing tumor
vascularity in women receiving neoadjuvant chemotherapy for infiltrative breast cancer.


- Compare the results obtained by semiquantitative measurement of vascularization (MRI)
vs traditional empirical evaluation.

- Evaluate the MRI accuracy for the measurement of tumoral volume after completion of

OUTLINE: This is an uncontrolled, nonrandomized study.

Patients receive neoadjuvant chemotherapy comprising epirubicin hydrochloride IV and
docetaxel IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of
disease progression or unacceptable toxicity.

Patients undergo dynamic-contrast MRI before treatment, 3 weeks after the first course of
chemotherapy, and 3 weeks after the completion of chemotherapy. They also undergo a
bilateral mammogram and sonography and clinical examination.

Within 22-35 days after completion of chemotherapy, patients undergo breast-conserving
surgical resection of tumor and lymph nodes or mastectomy.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed infiltrative breast cancer meeting 1 of the following

- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Outcome Measure:

Reproducibility and repeatability of MRI

Safety Issue:


Principal Investigator

Fabienne Valentin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut BergoniƩ


United States: Federal Government

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms