I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)

STATUS

Recruiting
End date

Dec 15, 2031
participants needed

4000
sponsor

QuantumLeap Healthcare Collaborative

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Updated on 15 May 2022

See if I qualify

paclitaxel

cancer

cyclophosphamide

ejection fraction

breast cancer

MRI

doxorubicin

metastasis

neutrophil count

carboplatin

pertuzumab

HER2

irinotecan

trastuzumab

cancer chemotherapy

erbb2

letrozole

mammogram

core needle biopsy

Summary

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.

Description

I-SPY will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show a high Bayesian predictive probability of being more effective than standard therapy will graduate from the trial with their corresponding biomarker signature(s). Regimens will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.

Details

Condition	Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
Treatment	Neratinib, SGN-LIV1A, PLX3397, Tucatinib, Standard therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab, AMG 386 and Trastuzumab, T-DM1 and Pertuzumab, Pertuzumab and Trastuzumab, Ganetespib, ABT-888, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, Cemiplimab, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Cemiplimab plus REGN3767, Amcenestrant, Tucatinib plus trastuzumab and pertuzumab, Trilaciclib with or without trastuzumab + pertuzumab, SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant + Abemaciclib, Amcenestrant + Letrozole
Clinical Study Identifier	NCT01042379
Sponsor	QuantumLeap Healthcare Collaborative
Last Modified on	15 May 2022

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Eligibility		Yes	No	Not Sure
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

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I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY)