Site for I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2

Brief description of study

Site for The I-SPY 2.2 protocol uses the same strategy as the I-SPY 2.0 protocol to optimize response, measuring the impact of each therapeutic regimen based on change in MRI volume as well as changes in other biomarkers. • Block A: Test the most promising novel agents without standard chemotherapy, • Targeted De-escalation: Patients who are predicted to have a complete response after Block A will proceed to surgical excision • Targeted early escalation: Patients with a poor imaging response at 3 weeks will repeat imaging at 6 weeks, and proceed to “Block B” if response is not identified. • Block B: Patients will proceed to the optimal treatment combinations (best-in-class for each subtype, based on results from I-SPY 2 and other practice changing trials) • Block C: Patients with persistent disease after Block B will proceed to AC (or AC+PD-1 for patients with TNBC), those with predicted complete response will proceed to definitive surgical resection. This approach allows evaluation of emerging new agents for their ability to achieve pCR alone or in combination with known effective agents and to optimize the sequence of therapy, minimizing toxicity and maximizing benefit. An important new tool to optimize therapy will be the use of Response Predictive Subtypes (RPS) in the I-SPY 2.2 protocol. Over the past decade, we have learned about better ways to classify tumors in order to best predict response to the kinds of agents that are being used in treatment today. All patients in the I-SPY 2.2 protocol will be classified using the standard receptor subtyping as well as new molecular profiles that allow us to generate an RPS for each patient. In summary, the I-SPY 2.2 protocol improvements include a combination of better tumor classification and the use of sequential regimens that will enable all patients in the trial to achieve the best response with the least toxicity.


Clinical Study Identifier: s22-00179
ClinicalTrials.gov Identifier: NCT01042379
Principal Investigator: Nancy Chan.
Other Investigators: Andrea Flieder, Beatriu Reig, Ugur Ozerdem, Farbod Darvishian, Danielle Seidman, Anastasiya Apanasyuk, Amber A Guth, Annmarie Johnson-Rowe, Yelena Novik, Ruth D. Sarmiento, Marleen I Meyers, Natalie Jill Klar, Karen L Hiotis, Sylvia Adams, Caitlin Elizabeth Ryan, Maryann J Kwa, Nina D'Abreo, Deborah M Axelrod, Amanda Marie Talmadge, Linda Moy, Ruth Oratz, Soojin Ahn, Douglas K Marks, Irina Rapoport, Monica M Sheth, Alexander A Hindenburg.


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