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

NCT ID: NCT00462696

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-12-31

Brief Summary

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.

Detailed 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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Woment treated with neoadjuvant chemotherapy for breast cancer

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.

Group Type: EXPERIMENTAL

Neoadjuvant chemotherapy

Intervention Type: 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.

Interventions

Neoadjuvant chemotherapy

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabienne Valentin, MD

Role: STUDY_CHAIR

Institut Bergonié

Locations

Institut Bergonie

Bordeaux, , France

Countries

France

Other Identifiers

IB-2005-37

Identifier Type: -

Identifier Source: org_study_id