MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer - Full Text View

Sponsored by:	Institut Bergonie
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00462696

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: docetaxel Drug: epirubicin hydrochloride Procedure: conventional surgery Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: mammography Procedure: neoadjuvant therapy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans Mammography

Drug Information available for: Docetaxel Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Uncontrolled
Official Title:	Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Reproducibility and repeatability of MRI [ Designated as safety issue: No ]

Secondary Outcome Measures:

Results of MRI vs mammogram [ Designated as safety issue: No ]
MRI accuracy [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462696

Locations

France
Institut Bergonie	Recruiting
Bordeaux, France, 33076
Contact: Fabienne Valentin, MD 33-556-333-751

Sponsors and Collaborators

Institut Bergonie

Investigators

Study Chair:

Fabienne Valentin, MD

Institut Bergonie

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000540537, IB-2005-37, INCA-RECF0144, IB-ISNA
Study First Received:	April 18, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00462696
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009