PRE-I-SPY Phase I/Ib Oncology Platform Program

Recruiting Phase 1 Interventional Study
HER2-positive Breast Cancer Metastatic Cancer Metastatic Breast Cancer Metastatic HER2-positive Metastatic Breast Cancer HER2 Mutation-Related Tumors HER-2 Protein Overexpression HER2-negative Breast Cancer Triple Negative Breast Cancer HR Positive Hormone Receptor-positive Breast Cancer Estrogen Receptor Positive Tumor Progesterone Receptor-positive Breast Cancer Hormone Receptor Negative Breast Carcinoma Solid Tumor Solid Tumor, Adult Solid Carcinoma HER2 Low Breast Cancer HER2 Low Breast Carcinoma ER Positive Breast Cancer PR-positive Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
124 (estimated)
Sponsor
QuantumLeap Healthcare Collaborative · Other
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About This Trial

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

Trial Locations
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Eligibility Criteria
General Inclusion Criteria (GIC): * GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be accep…
Contacts

Smita M Asare

(855) 866-0505

smita.asare@quantumleaphealth.org

CONTACT

Maria Pitsiouni, PhD

(415) 651-8047

m.pitsiouni@quantumleaphealth.org

CONTACT