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Contrast-Enhanced Breast MRI, MRS, And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment For Locally Advanced Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Contrast-Enhanced Breast MRI, MRS, And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment 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.

Inclusion Criteria


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

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

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:

Biologic therapy

- Not specified

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

Surgery

- Not specified

Other

- No other prior cytotoxic regimens

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Laura J. Esserman, MD, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000069280

NCT ID:

NCT00033397

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • inflammatory breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455