This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01042379
Recruitment Status : Recruiting
First Posted : January 5, 2010
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
QuantumLeap Healthcare Collaborative

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
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 Drug: Standard Therapy Drug: AMG 386 with or without Trastuzumab Drug: AMG 479 (Ganitumab) plus Metformin Drug: MK-2206 with or without Trastuzumab Drug: AMG 386 and Trastuzumab Drug: T-DM1 and Pertuzumab Drug: Pertuzumab and Trastuzumab Drug: Ganetespib Drug: ABT-888 Drug: Neratinib Drug: PLX3397 Drug: Pembrolizumab - 4 cycle Drug: Talazoparib plus Irinotecan Drug: Patritumab and Trastuzumab Drug: Pembrolizumab - 8 cycle Drug: SGN-LIV1A Drug: Durvalumab plus Olaparib Drug: SD-101 + Pembrolizumab Drug: Tucatinib plus trastuzumab and pertuzumab Drug: Cemiplimab Drug: Cemiplimab plus REGN3767 Drug: Trilaciclib with or without trastuzumab + pertuzumab Drug: SYD985 ([vic-]trastuzumab duocarmazine) Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab Drug: Amcenestrant Drug: Amcenestrant + Abemaciclib Drug: Amcenestrant + Letrozole Drug: ARX788 Drug: ARX788 + Cemiplimab Drug: VV1 + Cemiplimab Drug: Datopotamab deruxtecan Drug: Datopotamab deruxtecan + Durvalumab Drug: Zanidatamab Drug: Lasofoxifene Drug: Z-endoxifen Drug: ARV-471 Drug: ARV-471 + Letrozole Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
Actual Study Start Date : March 1, 2010
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: AMG 386 (Trebananib); (Trastuzumab) Herceptin

Drug: AMG 386 and Trastuzumab
Arm is closed.
Other Name: AMG 386 (Trebananib); Trastuzumab (Herceptin)
AMG 479 plus Metformin
Arm is closed.
 Drug: AMG 479 (Ganitumab) plus Metformin
Arm is closed.
Other Name: Ganitumab
Experimental: MK-2206 with or without Trastuzumab
Arm is closed.
 Drug: MK-2206 with or without Trastuzumab
Arm is closed.
Other Name: (Trastuzumab) Herceptin
Experimental: T-DM1 and Pertuzumab
Arm is closed.
 Drug: T-DM1 and Pertuzumab
Arm is closed.
Other Name: 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 Name: Pertuzumab (Perjeta); Trastuzumab (Herceptin)
Experimental: Ganetespib
Arm is closed.
 Drug: Ganetespib
Arm is closed.
ABT-888
Arm is closed.
 Drug: ABT-888
Arm is closed.
Other Name: Veliparib
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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: 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: 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 Name: 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 Name: Dato-DXd
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. MRI Volume [ Time Frame: Four time points during the on-study phase: Baseline, Post-randomization, Pre-AC treatment and Pre-Surgery ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042379


Contacts
Layout table for location contacts
Contact: Won Chang (855) 866-0505 w.chang@quantumleaphealth.org
Contact: Maria Pitsiouni, PhD m.pitsiouni@quantumleaphealth.org

Locations
Show Show 36 study locations
Sponsors and Collaborators
QuantumLeap Healthcare Collaborative
Investigators
Layout table for investigator information
Principal Investigator: Laura Esserman, MD, MBA University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Symmans WF, Yau C, Chen YY, Balassanian R, Klein ME, Pusztai L, Nanda R, Parker BA, Datnow B, Krings G, Wei S, Feldman MD, Duan X, Chen B, Sattar H, Khazai L, Zeck JC, Sams S, Mhawech-Fauceglia P, Rendi M, Sahoo S, Ocal IT, Fan F, LeBeau LG, Vinh T, Troxell ML, Chien AJ, Wallace AM, Forero-Torres A, Ellis E, Albain KS, Murthy RK, Boughey JC, Liu MC, Haley BB, Elias AD, Clark AS, Kemmer K, Isaacs C, Lang JE, Han HS, Edmiston K, Viscusi RK, Northfelt DW, Khan QJ, Leyland-Jones B, Venters SJ, Shad S, Matthews JB, Asare SM, Buxton M, Asare AL, Rugo HS, Schwab RB, Helsten T, Hylton NM, van 't Veer L, Perlmutter J, DeMichele AM, Yee D, Berry DA, Esserman LJ. Assessment of Residual Cancer Burden and Event-Free Survival in Neoadjuvant Treatment for High-risk Breast Cancer: An Analysis of Data From the I-SPY2 Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):1654-1663. doi: 10.1001/jamaoncol.2021.3690.
I-SPY2 Trial Consortium; Yee D, DeMichele AM, Yau C, Isaacs C, Symmans WF, Albain KS, Chen YY, Krings G, Wei S, Harada S, Datnow B, Fadare O, Klein M, Pambuccian S, Chen B, Adamson K, Sams S, Mhawech-Fauceglia P, Magliocco A, Feldman M, Rendi M, Sattar H, Zeck J, Ocal IT, Tawfik O, LeBeau LG, Sahoo S, Vinh T, Chien AJ, Forero-Torres A, Stringer-Reasor E, Wallace AM, Pusztai L, Boughey JC, Ellis ED, Elias AD, Lu J, Lang JE, Han HS, Clark AS, Nanda R, Northfelt DW, Khan QJ, Viscusi RK, Euhus DM, Edmiston KK, Chui SY, Kemmer K, Park JW, Liu MC, Olopade O, Leyland-Jones B, Tripathy D, Moulder SL, Rugo HS, Schwab R, Lo S, Helsten T, Beckwith H, Haugen P, Hylton NM, Van't Veer LJ, Perlmutter J, Melisko ME, Wilson A, Peterson G, Asare AL, Buxton MB, Paoloni M, Clennell JL, Hirst GL, Singhrao R, Steeg K, Matthews JB, Asare SM, Sanil A, Berry SM, Esserman LJ, Berry DA. Association of Event-Free and Distant Recurrence-Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer: Three-Year Follow-up Analysis for the I-SPY2 Adaptively Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1355-1362. doi: 10.1001/jamaoncol.2020.2535.
Chien AJ, Tripathy D, Albain KS, Symmans WF, Rugo HS, Melisko ME, Wallace AM, Schwab R, Helsten T, Forero-Torres A, Stringer-Reasor E, Ellis ED, Kaplan HG, Nanda R, Jaskowiak N, Murthy R, Godellas C, Boughey JC, Elias AD, Haley BB, Kemmer K, Isaacs C, Clark AS, Lang JE, Lu J, Korde L, Edmiston KK, Northfelt DW, Viscusi RK, Yee D, Perlmutter J, Hylton NM, Van't Veer LJ, DeMichele A, Wilson A, Peterson G, Buxton MB, Paoloni M, Clennell J, Berry S, Matthews JB, Steeg K, Singhrao R, Hirst GL, Sanil A, Yau C, Asare SM, Berry DA, Esserman LJ; I-SPY 2 Consortium. MK-2206 and Standard Neoadjuvant Chemotherapy Improves Response in Patients With Human Epidermal Growth Factor Receptor 2-Positive and/or Hormone Receptor-Negative Breast Cancers in the I-SPY 2 Trial. J Clin Oncol. 2020 Apr 1;38(10):1059-1069. doi: 10.1200/JCO.19.01027. Epub 2019 Feb 7.

Layout table for additonal information
Responsible Party: QuantumLeap Healthcare Collaborative
ClinicalTrials.gov Identifier: NCT01042379    
Other Study ID Numbers: 097517
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Keywords provided by QuantumLeap Healthcare Collaborative:
Neoadjuvant
Breast
Cancer
Neoplasm
Adaptive
pCR
 Pathologic Complete Response
Biomarkers signature
MRI Volume
Endocrine Therapy
Chemotherapy
Immunotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Hemangiosarcoma
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Metformin
Paclitaxel
Ado-Trastuzumab Emtansine
Albumin-Bound Paclitaxel
 Carboplatin
Doxorubicin
Pembrolizumab
Trastuzumab
Irinotecan
Durvalumab
Letrozole
Olaparib
Pertuzumab
Cemiplimab
Veliparib
Talazoparib
Dostarlimab
Trebananib
Tucatinib