Breast Cancer Clinical Trial
— I-SPYOfficial title:
I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
NCT number | NCT01042379 |
Other study ID # | 097517 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 1, 2010 |
Est. completion date | December 2031 |
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 2031 |
Est. primary completion date | December 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed invasive cancer of the breast - Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm) - No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed - Age =18 years - ECOG performance status 0-1 - Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers - Non-pregnant and non-lactating - No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible. - Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent) - Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis - Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F - Normal organ and marrow function: Leukocytes = 3000/µL, Absolute neutrophil count = 1500/µL, Platelets = 100,000/µL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be = 2.0 x ULN, AST(SGOT)/ALT (SGPT) = 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN - No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by = 50% - No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase - Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™) - Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2) Exclusion Criteria: - Use of any other investigational agents within 30 days of starting study treatment - History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements |
Country | Name | City | State |
---|---|---|---|
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | University of Colorado | Aurora | Colorado |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of Chicago | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University of Texas, Southwestern Medical Center | Dallas | Texas |
United States | City of Hope | Duarte | California |
United States | Inova Health System | Falls Church | Virginia |
United States | University of Texas, M.D. Anderson Cancer Center | Houston | Texas |
United States | University of California San Diego | La Jolla | California |
United States | Herbert-Herman Cancer Center, Sparrow Hospital | Lansing | Michigan |
United States | University of Southern California | Los Angeles | California |
United States | Loyola University | Maywood | Illinois |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Columbia University Medical Center | New York | New York |
United States | Laura and Isaac Perlmutter Cancer Center / NYU Langone Health | New York | New York |
United States | HOAG Memorial Hospital Presbyterian | Newport Beach | California |
United States | University of Pennsylvania (U Penn) | Philadelphia | Pennsylvania |
United States | University Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science Institute (OHSU) | Portland | Oregon |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Rochester Wilmot Cancer Institute | Rochester | New York |
United States | University of California San Francisco (UCSF) | San Francisco | California |
United States | Mayo Clinic - Scottsdale | Scottsdale | Arizona |
United States | Swedish Cancer Institute | Seattle | Washington |
United States | University of Washington | Seattle | Washington |
United States | Sanford Clinical Research | Sioux Falls | South Dakota |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | University of Arizona | Tucson | Arizona |
United States | Georgetown University Medical Center | Washington | District of Columbia |
United States | University of Kansas | Westwood | Kansas |
United States | Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
QuantumLeap Healthcare Collaborative |
United States,
Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther. 2009 Jul;86(1):97-100. doi: 10.1038/clpt.2009.68. Epub 2009 May 13. — View Citation
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, Carpe — View Citation
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 — View Citation
Esserman LJ, Woodcock J. Accelerating identification and regulatory approval of investigational cancer drugs. JAMA. 2011 Dec 21;306(23):2608-9. doi: 10.1001/jama.2011.1837. No abstract available. — View Citation
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 — View Citation
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: res — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. | Post surgery based on upto 36-week treatment | ||
Secondary | Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB). | Blood and Tissue Collection: Baseline, Post-Randomization, Pre-AC, Pre- and Post-Surgery | ||
Secondary | To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms. | Three- and Five-Year Post-surgery Follow-up | ||
Secondary | To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested. | Post-Randomization, Pre-AC, Pre-Surgery, Post-Surgery upto One Year during follow-up | ||
Secondary | MRI Volume | Four time points during the on-study phase: Baseline, Post-randomization, Pre-AC treatment and Pre-Surgery |
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