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

July 24, 2023 updated by: QuantumLeap Healthcare Collaborative

I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

I-SPY2 will assess the efficacy of novel drugs in sequence with standard chemotherapy. The goal is identify treatment strategies for subsets on the basis of molecular characteristics (biomarker signatures) of their disease with high estimated pCR rate. As described for previous adaptive trials, novel regimens with sufficiently high activities alone and contribute to treatment strategies that show a high Bayesian predictive probability of being more effective than the dynamic control will graduate from the trial with their corresponding biomarker signature(s). Treatment strategies 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.

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Erica Stringer-Reasor, MD
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Mayo Clinic - Scottsdale
        • Contact:
          • Phone Number: 507-538-7623
        • Principal Investigator:
          • Donald Northfelt, MD
      • Tucson, Arizona, United States, 85724
        • Active, not recruiting
        • University of Arizona
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Phone Number: 800-826-4673
        • Principal Investigator:
          • Jennifer Tseng, MD
      • La Jolla, California, United States, 92093-0698
        • Recruiting
        • University of California San Diego
        • Contact:
          • Phone Number: 858-822-6194
        • Contact:
        • Principal Investigator:
          • Anne Wallace, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
        • Principal Investigator:
          • Evanthia Roussos Torres, MD
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Principal Investigator:
          • Chaitali Nangia, MD
      • San Francisco, California, United States, 94115
        • Recruiting
        • University of California San Francisco (UCSF)
        • Contact:
          • Phone Number: 415-443-4296
        • Principal Investigator:
          • Amy Jo Chien, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Phone Number: 720-848-1622
        • Principal Investigator:
          • Anthony Elias, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center
        • Contact:
        • Sub-Investigator:
          • Tara Snaft, MD
        • Sub-Investigator:
          • Lajos Pusztai, MD
        • Principal Investigator:
          • Marlya Rozenblit, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
        • Contact:
        • Principal Investigator:
          • Claudine Isaacs, MD
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Heather Han, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
        • Principal Investigator:
          • Kevin Kalinsky, MD
    • Illinois
      • Chicago, Illinois, United States, 60453
        • Recruiting
        • University of Chicago
        • Contact:
          • Phone Number: 773-834-2756
        • Principal Investigator:
          • Rita Nanda, MD
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University
        • Contact:
          • Phone Number: 708-327-3102
        • Principal Investigator:
          • Kathy S Albain, MD
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Active, not recruiting
        • University of Kansas
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Herbert-Herman Cancer Center, Sparrow Hospital
        • Principal Investigator:
          • Brittani Thomas, DO
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Phone Number: 612-626-8487
        • Principal Investigator:
          • Douglas Yee, MD
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Phone Number: 507-538-7623
        • Principal Investigator:
          • Judy C Boughey, MD
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Coral Omene, MD, PhD
    • New York
      • Bronx, New York, United States, 10467
        • Not yet recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Jesus D Anampa
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Principal Investigator:
          • Meghana Trivedi, MD
      • Rochester, New York, United States, 14642
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Alexandra Thomas, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Julie Lang, MD
        • Contact:
          • Phone Number: 800-233-2273
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science Institute (OHSU)
        • Contact:
        • Contact:
          • Phone Number: 503-494-8573
        • Principal Investigator:
          • Alexandra Zimmer, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania (U Penn)
        • Contact:
          • Phone Number: 215-614-1850
        • Principal Investigator:
          • Amy Clark, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Active, not recruiting
        • University Pittsburgh Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Clinical Research
        • Principal Investigator:
          • Amy Sanford, MD
    • Tennessee
      • Nashville, Tennessee, United States, 27204
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Laura Kennedy, MD
    • Texas
      • Dallas, Texas, United States, 75390-9155
        • Active, not recruiting
        • University of Texas, Southwestern Medical Center
      • Houston, Texas, United States, 77230-1439
        • Active, not recruiting
        • University of Texas, M.D. Anderson Cancer Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Active, not recruiting
        • Inova Health System
    • Washington
      • Seattle, Washington, United States, 98104
        • Active, not recruiting
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98115
        • Active, not recruiting
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Therapy
Paclitaxel, Herceptin followed by Doxorubicin and Cyclophosphamide treatment depending on HR/HER-2 status.
Drug: Standard Therapy
Paclitaxel: 80 mg/m2 IV during the 12 weekly treatment cycles post randomization; Doxorubicin: 60 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16; Cyclophosphamide: 600 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16
Other Names:
  • Paclitaxel (Taxol); Doxorubicin (Adriamycin)
Experimental: AMG 386 with or without Trastuzumab
Arm is closed.
Drug: AMG 386 with or without Trastuzumab
Arm is closed.
Other Names:
  • AMG 386 (Trebananib); (Trastuzumab) Herceptin
Drug: AMG 386 and Trastuzumab
Arm is closed.
Other Names:
  • AMG 386 (Trebananib); Trastuzumab (Herceptin)
Other: AMG 479 plus Metformin
Arm is closed.
Drug: AMG 479 (Ganitumab) plus Metformin
Arm is closed.
Other Names:
  • Ganitumab
Experimental: MK-2206 with or without Trastuzumab
Arm is closed.
Drug: MK-2206 with or without Trastuzumab
Arm is closed.
Other Names:
  • (Trastuzumab) Herceptin
Experimental: T-DM1 and Pertuzumab
Arm is closed.
Drug: T-DM1 and Pertuzumab
Arm is closed.
Other Names:
  • T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta)
Active Comparator: Pertuzumab and Trastuzumab
Novel Control Investigational Agent. Arm is closed.
Drug: Pertuzumab and Trastuzumab
Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization; Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization
Other Names:
  • Pertuzumab (Perjeta); Trastuzumab (Herceptin)
Experimental: Ganetespib
Arm is closed.
Drug: Ganetespib
Arm is closed.
Other: ABT-888
Arm is closed.
Drug: ABT-888
Arm is closed.
Other Names:
  • Veliparib
Other: Neratinib
Arm is closed.
Drug: Neratinib
Arm is closed.
Experimental: PLX3397
Arm is closed.
Drug: PLX3397
Arm is closed.
Experimental: Pembrolizumab 4 cycle
Arm is closed.
Drug: Pembrolizumab - 4 cycle
Arm is closed.
Experimental: Talazoparib plus Irinotecan
Arm is closed.
Drug: Talazoparib plus Irinotecan
Arm is closed.
Experimental: Patritumab with or without Trastuzumab
Arm is closed.
Drug: Patritumab and Trastuzumab
Arm is closed.
Experimental: Pembrolizumab 8 cycle
Arm is closed.
Drug: Pembrolizumab - 8 cycle
Arm is closed.
Experimental: SGN-LIV1A
Arm is closed.
Drug: SGN-LIV1A
Arm is closed. SGN-LIV1A: 2.5 mg/kg IV cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16
Experimental: Durvalumab plus Olaparib
Arm is closed.
Drug: Durvalumab plus Olaparib
Arm is closed.
Experimental: SD-101 + Pembrolizumab
Arm is closed.
Drug: SD-101 + Pembrolizumab
Arm is closed. SD-101: IT injection 2 mg/ml (1 ml for T2 tumors, 2 ml for >T3 tumors) weekly x 4, then every 3 weeks x 2 cycles 1,2,3,4,7,10 Pembrolizumab: 200mg IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Experimental: Tucatinib
Arm is closed.
Drug: Tucatinib plus trastuzumab and pertuzumab
Arm is closed. Tucatinib: 300 mg PO BID 12 weeks CLOSED Tucatinib: 250 mg PO BID 12 weeks CLOSED Tucatinib adaptive: 150mg BID days 1-28, 250mg BID days 29-84 Trastuzumab: 4 mg/kg IV (loading dose) cycle 1; 2 mg/kg (thereafter) cycles 2-12 Pertuzumab: 840 mg IV (loading dose) cycle 1; 420 mg (thereafter) cycles 4, 7 and 10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Experimental: Cemiplimab
Novel Investigational Agent. Arm is closed.
Drug: Cemiplimab
Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Experimental: Cemiplimab plus REGN3767
Novel Investigational Agent. Arm is closed.
Drug: Cemiplimab plus REGN3767
Cemiplimab: 350 mg q3w X 12 weeks IV cycles 1,4,7,10 REGN 3767: 1600 mg q3W X 12 weeks IV cycles 1,4,7,10 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Experimental: Trilaciclib with or without trastuzumab + pertuzumab
Novel Investigational Agent. Arm is closed.
Drug: Trilaciclib with or without trastuzumab + pertuzumab

Trilaciclib: 240 mg/m2 IV weekly cycle 1-16 Paclitaxel: 80 mg/m2 IV cycles 1-12 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles

For HER2+:

Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization

Other Names:
  • Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin)
Experimental: SYD985 ([vic-]trastuzumab duocarmazine)
Novel Investigational Agent. Arm is closed.
Drug: SYD985 ([vic-]trastuzumab duocarmazine)
SYD985: 1.2 mg/kg IV (q3w x 12 weeks) cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16; Doxorubicin: 60 mg/m2 IV Every 2 or 3 weeks for 4 cycles; Cyclophosphamide: 600 mg/m2 IV Every 2 or 3 weeks for 4 cycles
Experimental: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab
Novel Investigational Agent. Arm is closed.
Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab

For HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg/kg cycle 1, then 2 mg/kg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

For HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Carboplatin, AUC 1.5, IV, q1wk from wk1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

Other Names:
  • Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin)
Experimental: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
Novel Investigational Agent. Arm is closed.
Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab

For HER2+ Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Trastuzumab, 4 mg/kg cycle 1, then 2 mg/kg cycles 2-12 q1wk, IV, for wk1-12 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

For HER2- Dostarlimab (TSR-042), 500 mg, IV, q3wks for wk 1, 4, 7, 10 Oral paclitaxel, 205 mg/m2, oral, daily for Three (3) days in a row each week for weeks 1-12 Oral encequidar, 15 mg, oral, daily for Three (3) days in a row each week for weeks 1-12 Followed by Doxorubicin: 60 mg/m2, IV, every 2 or 3 weeks for 4 cycles Cyclophosphamide: 600 mg/m2, IV, every 2 or 3 weeks for 4 cycle

Other Names:
  • Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin)
Experimental: Endocrine Optimization Pilot: Amcenestrant Monotherapy
Novel Investigational Agent. Arm is closed.
Drug: Amcenestrant
Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks
Other Names:
  • SAR439859
Experimental: Endocrine Optimization Pilot: Amcenestrant + Abemaciclib
Novel Investigational Agent. Arm is closed.
Drug: Amcenestrant + Abemaciclib
Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Abemaciclib (Verzenio), 150mg BID, p.o., for 24 weeks
Other Names:
  • Amcenestrant (SAR439859), Abemaciclib (Verzenio)
Experimental: Endocrine Optimization Pilot: Amcenestrant + Letrozole
Novel Investigational Agent. Arm is closed.
Drug: Amcenestrant + Letrozole
Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Letrozole (Femara), 2.5mg QD, p.o., for 24 weeks
Other Names:
  • Amcenestrant (SAR439859), Letrozole (Femara)
Experimental: ARX788 in Block A and followed by SOC in Block B
Novel investigational Agent followed by SOC
Drug: ARX788
ARX788, 1.5 mg/kg Q3W, IV for 12 weeks
Experimental: VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block B
Novel investigational Agent followed by SOC
Drug: VV1 + Cemiplimab
VV1, 3x10^9 TCID50 once (day-8), Intra-tumoral injection Cemiplimab, 350 mg Q3W, IV for 12 weeks
Other Names:
  • VOYAGER V1™
  • VSV-IFNβ-NIS
Experimental: Datopotamab Deruxtecan in Block A and followed by SOC in block B
Novel investigational Agent followed by SOC
Drug: Datopotamab deruxtecan
Dato-DXd, 6 mg/kg Q3W, IV for 12 weeks
Other Names:
  • Dato-DXd
Experimental: Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block B
Novel investigational Agent followed by SOC
Drug: Datopotamab deruxtecan + Durvalumab
Dato-DXd, 6 mg/kg Q3W, IV for 12 weeks Durvalumab, 1120 mg Q3W, IV for 12 weeks
Other Names:
  • Dato-DXd
Experimental: ARX788 + Cemiplimab in Block A and followed by SOC in Block B
Novel investigational Agent followed by SOC. Arm is closed.
Drug: ARX788 + Cemiplimab
ARX788, 1.5 mg/kg Q3W, IV for 12 weeks Cemiplimab, 350 mg Q3W, IV for 12 weeks
Experimental: Zanidatamab in Block A and followed by SOC in block B
Novel investigational Agent followed by SOC
Drug: Zanidatamab
Zanidatamab: Flat dose of 1,200mg Q2W for 12 weeks
Experimental: Endocrine Optimization Pilot: Lasofoxifene
Novel investigational Agent
Drug: Lasofoxifene
Lasofoxifene: 5.0 mg QD, p.o., for 24 weeks
Experimental: Endocrine Optimization Pilot: (Z)-Endoxifen
Novel investigational Agent
Drug: Z-endoxifen
Z-endoxifen: 10 mg QD, p.o., for 24 weeks
Experimental: Endocrine Optimization Pilot: ARV-471
Novel investigational Agent
Drug: ARV-471
ARV-471: 200 mg QD, p.o, for 24 weeks
Experimental: Endocrine Optimization Pilot: ARV-471 + Letrozole
Novel investigational Agent
Drug: ARV-471 + Letrozole
ARV-471: 200 mg QD, p.o, for 24 weeks Letrozole: 2.5 mg QD, p.o, for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Post surgery based on upto 36-week treatment
Post surgery based on upto 36-week treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB).
Time Frame: Blood and Tissue Collection: Baseline, Post-Randomization, Pre-AC, Pre- and Post-Surgery
Blood and Tissue Collection: Baseline, Post-Randomization, Pre-AC, Pre- and Post-Surgery
To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms.
Time Frame: Three- and Five-Year Post-surgery Follow-up
Three- and Five-Year Post-surgery Follow-up
To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.
Time Frame: Post-Randomization, Pre-AC, Pre-Surgery, Post-Surgery upto One Year during follow-up
Post-Randomization, Pre-AC, Pre-Surgery, Post-Surgery upto One Year during follow-up
MRI Volume
Time Frame: Four time points during the on-study phase: Baseline, Post-randomization, Pre-AC treatment and Pre-Surgery
Four time points during the on-study phase: Baseline, Post-randomization, Pre-AC treatment and Pre-Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QuantumLeap Healthcare Collaborative

Investigators

  • Principal Investigator: Laura Esserman, MD, MBA, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2010

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

December 31, 2009

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimated)

January 5, 2010

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 097517

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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