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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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new medicines along with regular cancer treatment to find the best combinations for breast cancer patients. It focuses on identifying which treatments work best based on specific cancer characteristics. Early signs of success are monitored using MRI scans and tests on blood and tissue samples.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My tumor's hormone and HER2 status fits the study's specific criteria.
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My blood counts and liver/kidney functions are within normal ranges.
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My breast tumor is larger than 2.5 cm after a biopsy.
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I am 18 years old or older.
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My cancer is at an advanced stage but hasn't spread beyond my lymph nodes above my collarbone.
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My breast cancer has been confirmed by a tissue examination.
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I am willing to have a biopsy of my breast cancer.
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My tests show no cancer spread to distant parts of my body.
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My heart is healthy with an ejection fraction of 50% or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

42Treatment 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: Sarilumab + Cemiplimab + Paclitaxel in Block B followed by SOC Block CExperimental Treatment1 Intervention
Novel investigational Agent
Group VIII: SYD985 ([vic-]trastuzumab duocarmazine)Experimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group IX: SGN-LIV1AExperimental Treatment1 Intervention
Arm is closed.
Group X: SD-101 + PembrolizumabExperimental Treatment1 Intervention
Arm is closed.
Group XI: Rilvegostomig + TDXd in Block A and followed by SOC in Block BExperimental Treatment1 Intervention
Novel investigational Agent
Group XII: Pembrolizumab 8 cycleExperimental Treatment1 Intervention
Arm is closed.
Group XIII: Pembrolizumab 4 cycleExperimental Treatment1 Intervention
Arm is closed.
Group XIV: Patritumab with or without TrastuzumabExperimental Treatment1 Intervention
Arm is closed.
Group XV: PLX3397Experimental Treatment1 Intervention
Arm is closed.
Group XVI: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumabExperimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group XVII: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumabExperimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group XVIII: NeratinibExperimental Treatment1 Intervention
Arm is closed.
Group XIX: MK-2206 with or without TrastuzumabExperimental Treatment1 Intervention
Arm is closed.
Group XX: GanetespibExperimental Treatment1 Intervention
Arm is closed.
Group XXI: Endocrine Optimization Pilot: LasofoxifeneExperimental Treatment1 Intervention
Novel investigational Agent
Group XXII: Endocrine Optimization Pilot: Amcenestrant MonotherapyExperimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group XXIII: Endocrine Optimization Pilot: Amcenestrant + LetrozoleExperimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group XXIV: Endocrine Optimization Pilot: Amcenestrant + AbemaciclibExperimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group XXV: Endocrine Optimization Pilot: ARV-471 + LetrozoleExperimental Treatment1 Intervention
Novel investigational Agent
Group XXVI: Endocrine Optimization Pilot: ARV-471 + AbemaciclibExperimental Treatment1 Intervention
Novel investigational Agent
Group XXVII: Endocrine Optimization Pilot: ARV-471Experimental Treatment1 Intervention
Novel investigational Agent
Group XXVIII: Endocrine Optimization Pilot: (Z)-Endoxifen + AbemaciclibExperimental Treatment1 Intervention
Novel investigational Agent
Group XXIX: Endocrine Optimization Pilot: (Z)-EndoxifenExperimental Treatment1 Intervention
Novel investigational Agent
Group XXX: Durvalumab plus OlaparibExperimental Treatment1 Intervention
Arm is closed.
Group XXXI: Datopotamab Deruxtecan in Block A and followed by SOC in block BExperimental Treatment1 Intervention
Novel investigational Agent followed by SOC
Group XXXII: Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block BExperimental Treatment1 Intervention
Novel investigational Agent followed by SOC
Group XXXIII: DAN222 + Niraparib in Block A and followed by SOC in Block BExperimental Treatment1 Intervention
Novel investigational Agent
Group XXXIV: Cemiplimab plus REGN3767Experimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group XXXV: CemiplimabExperimental Treatment1 Intervention
Novel Investigational Agent. Arm is closed.
Group XXXVI: ARX788 in Block A and followed by SOC in Block BExperimental Treatment1 Intervention
Novel investigational Agent followed by SOC
Group XXXVII: ARX788 + Cemiplimab in Block A and followed by SOC in Block BExperimental Treatment1 Intervention
Novel investigational Agent followed by SOC. Arm is closed.
Group XXXVIII: AMG 479 plus MetforminExperimental Treatment1 Intervention
Arm is closed.
Group XXXIX: AMG 386 with or without TrastuzumabExperimental Treatment2 Interventions
Arm is closed.
Group XL: ABT-888Experimental Treatment1 Intervention
Arm is closed.
Group XLI: Standard TherapyActive Control1 Intervention
Paclitaxel, Herceptin followed by Doxorubicin and Cyclophosphamide treatment depending on HR/HER-2 status.
Group XLII: 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
~470
ARV-471
2022
Completed Phase 2
~190
Lasofoxifene
2004
Completed Phase 2
~550
Cemiplimab
2015
Completed Phase 3
~1470
Ganetespib
2011
Completed Phase 2
~320

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: Endocrine Optimization Pilot: ARV-471 + Abemaciclib, Endocrine Optimization Pilot: (Z)-Endoxifen + Abemaciclib, Rilvegostomig + TDXd in Block A and followed by SOC in Block B, DAN222 + Niraparib in Block A and followed by SOC in Block B, Sarilumab + Cemiplimab + Paclitaxel in Block B followed by SOC Block C, 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
~1446 spots leftby Dec 2030
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