← Back to Search

Other

Personalized Adaptive Novel Agents for Breast Cancer (I-SPY Trial)

Phase 2

Recruiting

Led By Laura Esserman, MD, MBA

Research Sponsored by QuantumLeap Healthcare Collaborative

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0-1

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-randomization, pre-ac, pre-surgery, post-surgery upto one year during follow-up

Awards & highlights

I-SPY Trial Summary

This trial is testing new drugs for breast cancer and trying to find which early indicators predict success for different types of tumors.

Who is the study for?

This trial is for adults over 18 with invasive breast cancer, who haven't had chemotherapy or radiation for it. They must be non-pregnant, have normal organ function, and no metal implants incompatible with MRI. The cancer should be measurable in the breast and not spread far (specific stages). All hormone receptor statuses are eligible.Check my eligibility

What is being tested?

The study tests various new drugs against different types of breast tumors to personalize treatment. It uses MRI and tissue/blood samples before surgery to predict success. Drugs include Datopotamab deruxtecan, Durvalumab, Trilaciclib combinations, ABT-888 among others.See study design

What are the potential side effects?

Potential side effects may vary widely due to the range of drugs tested but can include allergic reactions similar to other compounds in their class, fatigue, digestive issues, blood disorders like low counts of white cells or platelets and possible heart problems.

I-SPY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

My tumor's hormone and HER2 status fits the study's specific criteria.

Select...

My blood counts and liver/kidney functions are within normal ranges.

Select...

My breast tumor is larger than 2.5 cm after a biopsy.

Select...

I am 18 years old or older.

Select...

My cancer is at an advanced stage but hasn't spread beyond my lymph nodes above my collarbone.

Select...

My breast cancer has been confirmed by a tissue examination.

Select...

I am willing to have a biopsy of my breast cancer.

Select...

My tests show no cancer spread to distant parts of my body.

Select...

My heart is healthy with an ejection fraction of 50% or higher.

I-SPY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three- and five-year post-surgery follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three- and five-year post-surgery follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and three- and five-year post-surgery follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB).

MRI Volume

To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.

+1 more

I-SPY Trial Design

37Treatment groups

Experimental Treatment

Active Control

Group I: Zanidatamab in Block A and followed by SOC in block BExperimental Treatment1 Intervention

Novel investigational Agent followed by SOC

Group II: VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block BExperimental Treatment1 Intervention

Novel investigational Agent followed by SOC

Group III: TucatinibExperimental Treatment1 Intervention

Arm is closed.

Group IV: Trilaciclib with or without trastuzumab + pertuzumabExperimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group V: Talazoparib plus IrinotecanExperimental Treatment1 Intervention

Arm is closed.

Group VI: T-DM1 and PertuzumabExperimental Treatment1 Intervention

Arm is closed.

Group VII: SYD985 ([vic-]trastuzumab duocarmazine)Experimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group VIII: SGN-LIV1AExperimental Treatment1 Intervention

Arm is closed.

Group IX: SD-101 + PembrolizumabExperimental Treatment1 Intervention

Arm is closed.

Group X: Pembrolizumab 8 cycleExperimental Treatment1 Intervention

Arm is closed.

Group XI: Pembrolizumab 4 cycleExperimental Treatment1 Intervention

Arm is closed.

Group XII: Patritumab with or without TrastuzumabExperimental Treatment1 Intervention

Arm is closed.

Group XIII: PLX3397Experimental Treatment1 Intervention

Arm is closed.

Group XIV: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumabExperimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group XV: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumabExperimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group XVI: NeratinibExperimental Treatment1 Intervention

Arm is closed.

Group XVII: MK-2206 with or without TrastuzumabExperimental Treatment1 Intervention

Arm is closed.

Group XVIII: GanetespibExperimental Treatment1 Intervention

Arm is closed.

Group XIX: Endocrine Optimization Pilot: LasofoxifeneExperimental Treatment1 Intervention

Novel investigational Agent

Group XX: Endocrine Optimization Pilot: Amcenestrant MonotherapyExperimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group XXI: Endocrine Optimization Pilot: Amcenestrant + LetrozoleExperimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group XXII: Endocrine Optimization Pilot: Amcenestrant + AbemaciclibExperimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group XXIII: Endocrine Optimization Pilot: ARV-471 + LetrozoleExperimental Treatment1 Intervention

Novel investigational Agent

Group XXIV: Endocrine Optimization Pilot: ARV-471Experimental Treatment1 Intervention

Novel investigational Agent

Group XXV: Endocrine Optimization Pilot: (Z)-EndoxifenExperimental Treatment1 Intervention

Novel investigational Agent

Group XXVI: Durvalumab plus OlaparibExperimental Treatment1 Intervention

Arm is closed.

Group XXVII: Datopotamab Deruxtecan in Block A and followed by SOC in block BExperimental Treatment1 Intervention

Novel investigational Agent followed by SOC

Group XXVIII: Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block BExperimental Treatment1 Intervention

Novel investigational Agent followed by SOC

Group XXIX: Cemiplimab plus REGN3767Experimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group XXX: CemiplimabExperimental Treatment1 Intervention

Novel Investigational Agent. Arm is closed.

Group XXXI: ARX788 in Block A and followed by SOC in Block BExperimental Treatment1 Intervention

Novel investigational Agent followed by SOC

Group XXXII: ARX788 + Cemiplimab in Block A and followed by SOC in Block BExperimental Treatment1 Intervention

Novel investigational Agent followed by SOC. Arm is closed.

Group XXXIII: AMG 479 plus MetforminExperimental Treatment1 Intervention

Arm is closed.

Group XXXIV: AMG 386 with or without TrastuzumabExperimental Treatment2 Interventions

Arm is closed.

Group XXXV: ABT-888Experimental Treatment1 Intervention

Arm is closed.

Group XXXVI: Standard TherapyActive Control1 Intervention

Paclitaxel, Herceptin followed by Doxorubicin and Cyclophosphamide treatment depending on HR/HER-2 status.

Group XXXVII: Pertuzumab and TrastuzumabActive Control1 Intervention

Novel Control Investigational Agent. Arm is closed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABT-888

2010

Completed Phase 2

~870

ARX788

2018

Completed Phase 1

~110

Neratinib

2014

Completed Phase 2

~1970

PLX3397

2011

Completed Phase 2

~460

ARV-471

2022

Completed Phase 1

~50

Lasofoxifene

2004

Completed Phase 2

~550

Cemiplimab

2015

Completed Phase 3

~1340

Ganetespib

2011

Completed Phase 2

~320

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

QuantumLeap Healthcare CollaborativeLead Sponsor

5 Previous Clinical Trials

1,977 Total Patients Enrolled

Laura Esserman, MD, MBAPrincipal InvestigatorUniversity of California, San Francisco

2 Previous Clinical Trials

100,017 Total Patients Enrolled

2 Trials studying Breast Cancer

100,017 Patients Enrolled for Breast Cancer

Media Library

Amcenestrant + Abemaciclib (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01042379 — Phase 2

Breast Cancer Research Study Groups: Zanidatamab in Block A and followed by SOC in block B, Ganetespib, Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block B, Endocrine Optimization Pilot: Lasofoxifene, Endocrine Optimization Pilot: (Z)-Endoxifen, AMG 386 with or without Trastuzumab, MK-2206 with or without Trastuzumab, Neratinib, Patritumab with or without Trastuzumab, Pembrolizumab 8 cycle, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Endocrine Optimization Pilot: Amcenestrant + Letrozole, ARX788 in Block A and followed by SOC in Block B, ARX788 + Cemiplimab in Block A and followed by SOC in Block B, VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block B, Datopotamab Deruxtecan in Block A and followed by SOC in block B, Endocrine Optimization Pilot: ARV-471, Endocrine Optimization Pilot: ARV-471 + Letrozole, T-DM1 and Pertuzumab, SGN-LIV1A, Endocrine Optimization Pilot: Amcenestrant + Abemaciclib, ABT-888, Durvalumab plus Olaparib, Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Standard Therapy, Pembrolizumab 4 cycle, AMG 479 plus Metformin, Endocrine Optimization Pilot: Amcenestrant Monotherapy, Pertuzumab and Trastuzumab, Cemiplimab, Talazoparib plus Irinotecan, PLX3397, SD-101 + Pembrolizumab, Tucatinib

Breast Cancer Clinical Trial 2023: Amcenestrant + Abemaciclib Highlights & Side Effects. Trial Name: NCT01042379 — Phase 2

Amcenestrant + Abemaciclib (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01042379 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health issues does the combination of Trilaciclib, trastuzumab and pertuzumab aim to address?

"Trilaciclib is a potential therapy for anovulatory cycles, melanoma, and metastatic neoplasms combined with or without trastuzumab + pertuzumab."

Answered by AI

Is this research endeavor accepting new participants?

"Affirmative. Clinicaltrials.gov details that this clinical trial, which first went live on March 1st 2010, is presently seeking volunteers. The study requires 5000 recruits to be found at 28 different medical sites."

Answered by AI

Have researchers investigated the effect of combining Trilaciclib with trastuzumab and pertuzumab in other studies?

"Currently, 642 trials for Trilaciclib with or without trastuzumab + pertuzumab are in their third phase of clinical testing. Furthermore, these tests can be found at 136713 different sites worldwide with a noteworthy concentration located within Seattle, Washington."

Answered by AI

How many individuals are allowed to take part in this medical experiment?

"Correct. The information on clinicaltrials.gov affirms that this medical trial, which was first listed on March 1st 2010, is currently recruiting patients. 5000 participants need to be enrolled from 28 different locations."

Answered by AI

How widespread is the implementation of this clinical investigation?

"Herbert-Herman Cancer Center, Sparrow Hospital in Lansing, Michigan, HOAG Memorial Hospital Presbyterian in Newport Beach, New york and University of Rochester Wilmot Cancer Institute in Rochester, New jersey are among the 28 sites that are recruiting for this trial."

Answered by AI

How have the interactions between Trilaciclib, trastuzumab and pertuzumab been assessed for safety?

"Due to its Phase 2 status, meaning there is some data available in regards to safety but none for efficacy, Trilaciclib with or without trastuzumab + pertuzumab has been assigned a score of 2."

Answered by AI