MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462696
• Other study ID #: CDR0000540537
• Secondary ID: IB-2005-37INCA-R
• Status: Completed
• Phase: N/A
• First received: April 18, 2007
• Last updated: May 12, 2011
• Start date: February 2006

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

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

Secondary

• 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 chemotherapy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

• epirubicin hydrochloride

Procedure:
• conventional surgery

• dynamic contrast-enhanced magnetic resonance imaging

• neoadjuvant therapy

• radiomammography

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility and repeatability of MRI			No
Secondary	Results of MRI vs mammogram			No
Secondary	MRI accuracy			No