NCT01564368

Brief Summary

RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to treatment. PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in patients with breast cancer undergoing neoadjuvant chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

7 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

First Submitted

Initial submission to the registry

March 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

August 27, 2012

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 10, 2023

Completed
Last Updated

April 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5.9 years

First QC Date

March 24, 2012

Results QC Date

January 12, 2023

Last Update Submit

March 18, 2024

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerHER2-negative breast cancerHER2-positive breast cancer

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response (pCR)

    Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer. ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system

    Surgery

Secondary Outcomes (6)

  • Functional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR)

    Surgery

  • Determine the Accuracy of Predictive Models Including Covariates for Combined Measurement of Change in Tumor ADC Value, Change in Tumor Volume, and Other Variables

    baseline and mid-treatment

  • Repeatability Coefficient (RC)Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors

    baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)

  • Within-subject Coefficient of Variation (wCV) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors

    baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)

  • ICC Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors

    baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment)

  • +1 more secondary outcomes

Study Arms (1)

Diffusion Weighted-MRI

EXPERIMENTAL

Participants on all arms of the I-SPY II trial will undergo diffusion-weighted magnetic resonance imaging as described in the ACRIN 6698 protocol. The experimental component/intervention is whether DW-MRI can predict therapeutic response in neoadjuvant treatment for breast cancer.

Procedure: diffusion-weighted magnetic resonance imaging

Interventions

diffusion-weighted magnetic resonance imagingPROCEDURE

diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation

Also known as: functional MRI, DWI, diffusion-weighted MRI, DW-MRI
Diffusion Weighted-MRI

Eligibility Criteria

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

You may qualify if:

  • High-risk for recurrent disease
  • PATIENT CHARACTERISTICS:
  • Able to tolerate imaging required by protocol
  • PRIOR CONCURRENT THERAPY:
  • Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington/SCCA

Seattle, Washington, 98195, United States

Location

Related Publications (7)

  • DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.

    PMID: 3203132BACKGROUND

  • Li W, Partridge SC, Newitt DC, Steingrimsson J, Marques HS, Bolan PJ, Hirano M, Bearce BA, Kalpathy-Cramer J, Boss MA, Teng X, Zhang J, Cai J, Kontos D, Cohen EA, Mankowski WC, Liu M, Ha R, Pellicer-Valero OJ, Maier-Hein K, Rabinovici-Cohen S, Tlusty T, Ozery-Flato M, Parekh VS, Jacobs MA, Yan R, Sung K, Kazerouni AS, DiCarlo JC, Yankeelov TE, Chenevert TL, Hylton NM. Breast Multiparametric MRI for Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer: The BMMR2 Challenge. Radiol Imaging Cancer. 2024 Jan;6(1):e230033. doi: 10.1148/rycan.230033.

    PMID: 38180338RESULT

  • Partridge SC, Zhang Z, Newitt DC, Gibbs JE, Chenevert TL, Rosen MA, Bolan PJ, Marques HS, Romanoff J, Cimino L, Joe BN, Umphrey HR, Ojeda-Fournier H, Dogan B, Oh K, Abe H, Drukteinis JS, Esserman LJ, Hylton NM; ACRIN 6698 Trial Team and I-SPY 2 Trial Investigators. Diffusion-weighted MRI Findings Predict Pathologic Response in Neoadjuvant Treatment of Breast Cancer: The ACRIN 6698 Multicenter Trial. Radiology. 2018 Dec;289(3):618-627. doi: 10.1148/radiol.2018180273. Epub 2018 Sep 4.

    PMID: 30179110RESULT

  • Newitt DC, Amouzandeh G, Partridge SC, Marques HS, Herman BA, Ross BD, Hylton NM, Chenevert TL, Malyarenko DI. Repeatability and Reproducibility of ADC Histogram Metrics from the ACRIN 6698 Breast Cancer Therapy Response Trial. Tomography. 2020 Jun;6(2):177-185. doi: 10.18383/j.tom.2020.00008.

    PMID: 32548294RESULT

  • Newitt DC, Zhang Z, Gibbs JE, Partridge SC, Chenevert TL, Rosen MA, Bolan PJ, Marques HS, Aliu S, Li W, Cimino L, Joe BN, Umphrey H, Ojeda-Fournier H, Dogan B, Oh K, Abe H, Drukteinis J, Esserman LJ, Hylton NM; ACRIN Trial Team and I-SPY 2 TRIAL Investigators. Test-retest repeatability and reproducibility of ADC measures by breast DWI: Results from the ACRIN 6698 trial. J Magn Reson Imaging. 2019 Jun;49(6):1617-1628. doi: 10.1002/jmri.26539. Epub 2018 Oct 22.

    PMID: 30350329RESULT

  • Partridge SC, Steingrimsson J, Newitt DC, Gibbs JE, Marques HS, Bolan PJ, Boss MA, Chenevert TL, Rosen MA, Hylton NM. Impact of Alternate b-Value Combinations and Metrics on the Predictive Performance and Repeatability of Diffusion-Weighted MRI in Breast Cancer Treatment: Results from the ECOG-ACRIN A6698 Trial. Tomography. 2022 Mar 4;8(2):701-717. doi: 10.3390/tomography8020058.

    PMID: 35314635RESULT

  • Newitt DC, Tan ET, Wilmes LJ, Chenevert TL, Kornak J, Marinelli L, Hylton N. Gradient nonlinearity correction to improve apparent diffusion coefficient accuracy and standardization in the american college of radiology imaging network 6698 breast cancer trial. J Magn Reson Imaging. 2015 Oct;42(4):908-19. doi: 10.1002/jmri.24883. Epub 2015 Mar 11.

    PMID: 25758543RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Senior Director Clinical Research Administration
Organization
American College of Radiology
info@acr.org
215-574-3150

Study Officials

  • Nola M. Hylton, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2012

First Posted

March 27, 2012

Study Start

August 27, 2012

Primary Completion

July 19, 2018

Study Completion

January 14, 2020

Last Updated

April 15, 2024

Results First Posted

February 10, 2023

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

See ACRIN data sharing Policy https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6mo post publication
Access Criteria
upon request
More information

Locations

US(7)