Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00033397
First received: April 9, 2002
Last updated: July 23, 2015
Last verified: July 2015

April 9, 2002
July 23, 2015
February 2002
May 2012   (final data collection date for primary outcome measure)
response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00033397 on ClinicalTrials.gov Archive Site
Not Provided
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Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
Contrast-Enhanced Breast MRI, MRS, And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment For Locally Advanced Breast Cancer

RATIONALE: Comparing results of diagnostic procedures performed before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.

PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women who are receiving chemotherapy before surgery for locally advanced breast cancer.

OBJECTIVES:

Primary

  • Support accrual to the ACRIN-6657/CALGB-150012 magnetic resonance imaging (MRI) correlative science study.
  • Determine whether molecular markers, alone or in combination with MRI, at the time of diagnosis or early in the course of therapy, predict 3-year disease-free survival (DFS) in women with locally advanced breast cancer who are receiving neoadjuvant chemotherapy.
  • Identify two groups of participants who have statistically different 3-year DFS, based on 1 or more biomarkers, including MRI.
  • Determine whether biomarkers, in combination with MRI, early in the course of chemotherapy, improve the prediction of 3-year DFS and are at least as good of a predictor of DFS as residual disease at the time of surgery in these patients.
  • Determine whether molecular markers are associated with specific imaging patterns seen on MRI of these patients.
  • Predict response with MRI results and marker data from cell cycle check points, proliferation, angiogenesis, hormone receptors, and molecular profiles in these patients.

Secondary

  • Determine the molecular predictors of lack of radiologic complete response (CR) in HER-2/neu negative patients (immunohistochemistry [IHC] score of 0, 1+, 2 and fluorescence in situ hybridization [FISH] not amplified) after a neoadjuvant anthracycline-based regimen.
  • Determine the molecular predictors of lack of radiologic CR in HER-2/neu positive patients (IHC 3+ or FISH amplified > 2.0) after a neoadjuvant anthracycline-based regime followed by a taxane alone regimen or in combination with trastuzumab.
  • Determine the molecular predictors of complete magnetic resonance imaging radiologic response to a neoadjuvant anthracycline-based regimen when gene expression profiling is performed in a sequential, real-time fashion.

OUTLINE: This is a diagnostic, multicenter study conducted concurrently with CALGB-150012/ACRIN-6657 imaging protocol and concurrently with neoadjuvant anthracycline-based chemotherapy.

Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) of the breast before initiation, 1-3 days after initiation, and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery. Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan.

Patients undergo biopsies before initiation and at the time of surgery. Patients also undergo blood draws at the time of the first biopsy and prior to surgery. Serum and tissue samples are used to assess biomarkers of genetic instability, cell cycle progression and cellular proliferation as predictors for anthracycline responsiveness, markers of apoptotic potential as predictors for taxane responsiveness in vivo, angiogenesis, hormone receptors, and molecular profiles using immunohistochemical methods.

Mammograms and possibly ultrasounds are performed prior to and after chemotherapy (before surgery).

Patients are followed every 6 months for 5 years and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 384 patients will be accrued for this study within 3 years.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Procedure: biopsy
  • Procedure: magnetic resonance imaging
  • Procedure: radiomammography
  • Procedure: ultrasound imaging
  • Radiation: gadopentetate dimeglumine
  • Drug: chemotherapy
Experimental: Arm A

Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) of the breast before initiation, 1-3 days after initiation, and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery. Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan.

Mammograms and possibly ultrasounds are performed prior to and after chemotherapy (before surgery).

Patients are followed every 6 months for 5 years and then annually for up to 10 years.

Interventions:
  • Procedure: biopsy
  • Procedure: magnetic resonance imaging
  • Procedure: radiomammography
  • Procedure: ultrasound imaging
  • Radiation: gadopentetate dimeglumine
  • Drug: chemotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
384
Not Provided
May 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed adenocarcinoma of the breast by core needle biopsy, incisional biopsy, or fine needle aspiration (FNA)

    • Incisional biopsy must result in < 10% removal of gross residual disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan OR
  • Nonmeasurable disease
  • Meets one of the following staging criteria:

    • Stage II or III disease
    • T4, any N, M0, including clinical or pathologic inflammatory disease
    • Regional stage IV disease where supraclavicular/infraclavicular lymph nodes are only site of metastasis
  • No clinical or imaging evidence of distant metastasis
  • Metaplastic carcinomas allowed
  • Synchronous bilateral primaries allowed if the more advanced tumor meets staging criteria
  • Patients for whom FNA was used to confirm initial diagnosis must have histologically confirmed invasive carcinoma by the start of chemotherapy
  • Her-2/neu status known
  • Currently receiving neoadjuvant chemotherapy consisting of a taxane-based regimen alone or followed by an anthracycline-based regimen
  • Concurrent enrollment in the ACRIN-6657/CALGB-150012 imaging protocol required
  • Hormone receptor status:

    • Any estrogen receptor or progesterone receptor status

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female Cardiovascular
  • No uncontrolled or severe cardiovascular disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No ferromagnetic prostheses including the following:

    • Metallic implants not compatible with a magnetic resonance imaging machine
    • Heart valves
    • Aneurysm clips
    • Orthopedic prosthesis
    • Any metallic fragments anywhere in the body

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy to the ipsilateral breast for this malignancy

Endocrine therapy

  • At least 4 weeks since prior tamoxifen or raloxifene

Radiotherapy

  • No prior radiotherapy to the ipsilateral breast for this malignancy

Other

  • No other prior cytotoxic regimens
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033397
CALGB-150007, CALGB-150007, CDR0000069280
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Laura J. Esserman, MD, MBA University of California, San Francisco
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP