NCT00043017

Brief Summary

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may help determine the effectiveness of chemotherapy in killing breast cancer and allow doctors to plan more effective treatment. PURPOSE: Diagnostic trial to study the effectiveness of MRI in monitoring tumor response in women who are receiving chemotherapy for stage III breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started May 2002

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

August 5, 2002

Last Update Submit

October 7, 2013

Conditions

Breast Cancer

Keywords

stage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free three-year survival

    3 years

Secondary Outcomes (9)

  • Extent of residual disease

    3 years

  • Change in the maximum dimension of the tumor over time

    3 years

  • Change in the tumor volume over time

    3 years

  • Maximum dimension of tumor size measure by MRI, mammography, and pathology

    3 years

  • MRI volume

    3 years

  • +4 more secondary outcomes

Study Arms (1)

MRI/MRS

EXPERIMENTAL

MRI and MRS examinations with standard imaging, with contrast enhancement using an agent (gadopentetate dimeglumine).

Procedure: MRI/MRSRadiation: gadopentetate dimeglumine

Interventions

MRI/MRSPROCEDURE

Serial MRI studies evaluated for prognostic properties related to therapeutic response.

Also known as: magnetic resonance imaging, magnetic resonance spectoscopy
MRI/MRS
gadopentetate dimeglumineRADIATION

Imaging agent used for contrast enhancement in each of the MRIs.

Also known as: contrast enhancing agent, MRI contrast, enhanced MRI
MRI/MRS

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Creatinine Clearance for Males: (\[140-age (years)\] X weight (kg)/(serum creatinine X 72) Creatinine Clearance for Females: Creatinine Clearance (male) X 0.85

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Research Consortium

Rochester, Minnesota, 55905, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9085, United States

Location

Related Publications (16)

  • Carey LA, Oh D, Sawyer L, et al.: Gene expression subtype and p53 mutational status are correlated among neoadjuvantly treated breast cancers in UNC LCCC9819 and I-SPY1 (CALGB 150007/ACRIN 6657). [Abstract] J Clin Oncol 24 (Suppl 18): A-10048, 552s, 2006.

    BACKGROUND

  • Esserman LJ, Berry DA, Cheang MC, Yau C, Perou CM, Carey L, DeMichele A, Gray JW, Conway-Dorsey K, Lenburg ME, Buxton MB, Davis SE, van't Veer LJ, Hudis C, Chin K, Wolf D, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Livasy C, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, Au A, Hylton N; I-SPY 1 TRIAL Investigators. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat. 2012 Apr;132(3):1049-62. doi: 10.1007/s10549-011-1895-2. Epub 2011 Dec 25.

    PMID: 22198468RESULT

  • Esserman LJ, Berry DA, DeMichele A, Carey L, Davis SE, Buxton M, Hudis C, Gray JW, Perou C, Yau C, Livasy C, Krontiras H, Montgomery L, Tripathy D, Lehman C, Liu MC, Olopade OI, Rugo HS, Carpenter JT, Dressler L, Chhieng D, Singh B, Mies C, Rabban J, Chen YY, Giri D, van 't Veer L, Hylton N. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results from the I-SPY 1 TRIAL--CALGB 150007/150012, ACRIN 6657. J Clin Oncol. 2012 Sep 10;30(26):3242-9. doi: 10.1200/JCO.2011.39.2779. Epub 2012 May 29.

    PMID: 22649152RESULT

  • Hylton NM, Blume JD, Bernreuter WK, Pisano ED, Rosen MA, Morris EA, Weatherall PT, Lehman CD, Newstead GM, Polin S, Marques HS, Esserman LJ, Schnall MD; ACRIN 6657 Trial Team and I-SPY 1 TRIAL Investigators. Locally advanced breast cancer: MR imaging for prediction of response to neoadjuvant chemotherapy--results from ACRIN 6657/I-SPY TRIAL. Radiology. 2012 Jun;263(3):663-72. doi: 10.1148/radiol.12110748.

    PMID: 22623692RESULT

  • Lin C, Buxton MB, Moore D, Krontiras H, Carey L, DeMichele A, Montgomery L, Tripathy D, Lehman C, Liu M, Olapade O, Yau C, Berry D, Esserman LJ; I-SPY TRIAL Investigators. Locally advanced breast cancers are more likely to present as Interval Cancers: results from the I-SPY 1 TRIAL (CALGB 150007/150012, ACRIN 6657, InterSPORE Trial). Breast Cancer Res Treat. 2012 Apr;132(3):871-9. doi: 10.1007/s10549-011-1670-4. Epub 2011 Jul 28.

    PMID: 21796368RESULT

  • Esserman LJ, Perou C, Cheang M, et al.: Breast cancer molecular profiles and tumor response of neoadjuvant doxorubicin and paclitaxel: The I-SPY TRIAL (CALGB 150007/150012, ACRIN 6657). [Abstract] J Clin Oncol 27 (Suppl 15): A-LBA515, 2009.

    RESULT

  • Hylton N, Blume J, Gatsonis C, et al.: MRI tumor volume for predicting response to neoadjuvant chemotherapy in locally advanced breast cancer: findings from ACRIN 6657/CALGB 150007. [Abstract] J Clin Oncol 27 (Suppl 15): A-529, 2009.

    RESULT

  • Lin C, Moore D, DeMichele A, et al.: Detection of locally advanced breast cancer in the I-SPY TRIAL (CALGB 150007/150012, ACRIN 6657) in the interval between routine screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-1503, 2009.

    RESULT

  • Pradhan SM, Carey L, Edmiston S, et al.: P53 mutation and differential response to neoadjuvant chemotherapy in women with locally advanced breast cancer: results from the I-SPY trial (CALGB 150007/1500012 and ACRIN 6657). [Abstract] J Clin Oncol 27 (Suppl 15): A-11099, 2009.

    RESULT

  • Van 't Veer LJ, Das D, DeMichele A, et al.: Neoadjuvant response in the context of a biologically defined low or high risk tumor has a different clinical consequence, the I-SPY trial (CALGB 150007/150012, ACRIN 6657). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-2003, 2009.

    RESULT

  • Wolf DM, Das D, Lenburg ME, et al.: From the lab to the clinic: gene-expression profiles that are associated with Mek-inhibitor sensitivity in vitro are coordinately co-expressed in breast cancer biopsy samples from the I-SPY Trial (CALGB 150007/150012, ACRIN 6657). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-2042, 2009.

    RESULT

  • Esserman LJ, van't Veer LJ, Perou C, et al.: Biology of breast cancers that present as interval cancers and at young age should inform how we approach early detection and prevention. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6034, 2008.

    RESULT

  • Gomez RE, Zakhireh J, Moore D, et al.: Sentinel node biopsy performed in the neoadjuvant setting for breast cancer: results from the I-SPY TRIAL (CALGB 150007/150012 & ACRIN 6657). [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-202, 2008.

    RESULT

  • Hylton NM, Blume JD, Bernreuter WK, et al.: Comparison of MRI endpoints for assessing breast cancer response to neoadjuvant treatment: preliminary findings of the American College of Radiology Imaging Network (ACRIN) trial 6657. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6043, 2008.

    RESULT

  • Livasy C, Carey L, DeMichele A, et al.: Influence of anthracycline- and taxane-based neoadjuvant chemotherapy on tumor HER2 protein expression in locally advanced breast cancers: results from the I-SPY TRIAL (CALGB 150007/150012 & ACRIN 6657). [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-703, 2008.

    RESULT

  • Livasy C, Carey L, DeMichele A, et al.: Biomarkers associated with pathologic complete response to neoadjuvant chemotherapy in women with locally advanced breast cancer: results from the I-SPY TRIAL (CALGB 150007/150012 & ACRIN 6657). [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-5102, 2008.

    RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance SpectroscopyGadolinium DTPA

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesPentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Nola M. Hylton, PhD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2002

First Posted

January 27, 2003

Study Start

May 1, 2002

Primary Completion

May 1, 2005

Study Completion

March 1, 2011

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

US(11)