MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer (ISNA-Sein)

Institut Bergonié

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Neoadjuvant chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00462696

IB-2005-37

Details and patient eligibility

About

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.

Full description

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

Enrollment: 16 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Woment treated with neoadjuvant chemotherapy for breast cancer

Experimental group

Description:

The patient will be recruited during a multidisciplinary team meeting (MDT) involving a medical oncologist, radiation oncologist, and surgeon. The histological diagnosis of invasive breast cancer will be confirmed based on the results of the micro-biopsy, which will be performed during the MDT meeting, after the initial MRI scan. The patient will submit her signed informed consent form. The MRI will be performed before the micro-biopsy so as not to distort the measurement of the tumor volume by a possible post-collection hematoma.

Treatment:

Drug: Neoadjuvant chemotherapy