Recruiting
Phase 2

Neoadjuvant Agents

Sponsor:

QuantumLeap Healthcare Collaborative

Code:

NCT01042379

Conditions

Breast Neoplasms

Breast Cancer

Breast Tumors

Angiosarcoma

TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Therapy

AMG 386 with or without Trastuzumab

AMG 479 (Ganitumab) plus Metformin

MK-2206 with or without Trastuzumab

AMG 386 and Trastuzumab

Study Details

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.

Conditions

Breast Neoplasms

Breast Cancer

Breast Tumors

Angiosarcoma

TNBC - Triple-Negative Breast Cancer

Study ID

NCT01042379

Start date

Mar 1, 2010

Status verified date

May, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Therapy

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

experimental: AMG 386 with or without Trastuzumab

Arm is closed.

other: AMG 479 plus Metformin

Arm is closed.

experimental: MK-2206 with or without Trastuzumab

Arm is closed.

experimental: T-DM1 and Pertuzumab

Arm is closed.

active comparator: Pertuzumab and Trastuzumab

Arm is closed. Novel Control Investigational Agent.

experimental: Ganetespib

Arm is closed.

other: ABT-888

Arm is closed.

other: Neratinib

Arm is closed.

experimental: PLX3397

Arm is closed.

experimental: Pembrolizumab 4 cycle

Arm is closed.

experimental: Talazoparib plus Irinotecan

Arm is closed.

experimental: Patritumab with or without Trastuzumab

Arm is closed.

experimental: Pembrolizumab 8 cycle

Arm is closed.

experimental: SGN-LIV1A

Arm is closed.

experimental: Durvalumab plus Olaparib

Arm is closed.

experimental: SD-101 + Pembrolizumab

Arm is closed.

experimental: Tucatinib

Arm is closed.

experimental: Cemiplimab

Arm is closed. Novel Investigational Agent.

experimental: Cemiplimab plus REGN3767

Arm is closed. Novel Investigational Agent.

experimental: Trilaciclib with or without trastuzumab + pertuzumab

Arm is closed. Novel Investigational Agent.

experimental: SYD985 ([vic-]trastuzumab duocarmazine)

Arm is closed. Novel Investigational Agent.

experimental: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab

Arm is closed. Novel Investigational Agent.

experimental: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab

Arm is closed. Novel Investigational Agent.

experimental: Endocrine Optimization Pilot: Amcenestrant Monotherapy

Arm is closed. Novel Investigational Agent.

experimental: Endocrine Optimization Pilot: Amcenestrant + Abemaciclib

Arm is closed. Novel Investigational Agent.

experimental: Endocrine Optimization Pilot: Amcenestrant + Letrozole

Arm is closed. Novel Investigational Agent.

experimental: ARX788 in Block A and followed by SOC in Block B

Arm is closed for accrual for accrual. Novel investigational Agent followed by SOC.

experimental: ARX788 + Cemiplimab in Block A and followed by SOC in Block B

Arm is closed for accrual. Novel investigational Agent followed by SOC.

experimental: VSV-IFNβ-NIS (VOYAGER V1™; VV1) + Cemiplimab in Block A and followed by SOC in block B

Arm is closed for accrual. Novel investigational Agent followed by SOC.

experimental: Datopotamab Deruxtecan in Block A and followed by SOC in block B

Arm is closed for accrual. Novel investigational Agent followed by SOC.

experimental: Datopotamab Deruxtecan + Durvalumab in Block A and followed by SOC in block B

Arm is closed for accrual. Novel investigational Agent followed by SOC.

experimental: Zanidatamab for Block ABC

Arm open for accrual. Novel investigational Agent.

experimental: Endocrine Optimization Pilot: Lasofoxifene

Arm is closed for accrual. Novel investigational Agent.

experimental: Endocrine Optimization Pilot: (Z)-Endoxifen

Arm is closed for accrual. Novel investigational Agent.

experimental: Endocrine Optimization Pilot: ARV-471

Arm is closed for accrual. Novel investigational Agent.

experimental: Endocrine Optimization Pilot: ARV-471 + Letrozole

Arm is closed for accrual. Novel investigational Agent.

experimental: Endocrine Optimization Pilot: ARV-471 + Abemaciclib

Arm is closed for accrual. Novel investigational Agent.

experimental: Endocrine Optimization Pilot: (Z)-Endoxifen + Abemaciclib

Arm is closed for accrual. Enrollment completed. Novel investigational Agent.

experimental: Rilvegostomig + TDXd in Block A and followed by SOC in Block B

Arm is closed for accrual. Novel investigational Agent.

experimental: DAN222 + Niraparib in Block A and followed by SOC in Block B

Arm is closed for accrual. Novel investigational Agent.

experimental: Sarilumab + Cemiplimab + Paclitaxel in Block B followed by SOC Block C

Arm is closed for accrual. Novel investigational Agent.

experimental: GSK 5733584 in Block A and followed by SOC in Block B

Arm is open for accrual. Novel Investigational Agent.

experimental: GSK 5733584 + Dostarlimab in Block A and followed by SOC in Block B

Arm is open for accrual. Novel Investigational Agent.

experimental: Ivonescimab in Blocks A and B

Open for accrual. Novel Investigational Agent.

Interventions

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

AMG 386 with or without Trastuzumab

Arm is closed.

AMG 479 (Ganitumab) plus Metformin

Arm is closed.

MK-2206 with or without Trastuzumab

Arm is closed.

AMG 386 and Trastuzumab

Arm is closed.

T-DM1 and Pertuzumab

Arm is closed.

Pertuzumab and Trastuzumab

Arm is closed for Accrual.

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

Ganetespib

Arm is closed.

ABT-888

Arm is closed.

Neratinib

Arm is closed.

PLX3397

Arm is closed.

Pembrolizumab - 4 cycle

Arm is closed.

Talazoparib plus Irinotecan

Arm is closed.

Patritumab and Trastuzumab

Arm is closed.

Pembrolizumab - 8 cycle

Arm is closed.

SGN-LIV1A

Arm is closed. SGN-LIV1A: 2.5 mg/kg IV cycles 1,4,7,10 Doxorubicin + Cyclophosphamide: Cycles 13-16

Durvalumab plus Olaparib

Arm is closed.

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

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

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

Cemiplimab plus REGN3767

Arm is closed.

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

Trilaciclib with or without trastuzumab + pertuzumab

Arm closed for accrual.

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

SYD985 ([vic-]trastuzumab duocarmazine)

Arm is closed.

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

Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab

Arm is closed.

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

Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab

Arm is closed.

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

Amcenestrant

Arm is closed.

Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks.

Amcenestrant + Abemaciclib

Arm is closed.

Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Abemaciclib (Verzenio), 150mg BID, p.o., for 24 weeks

Amcenestrant + Letrozole

Arm is closed.

Amcenestrant (SAR439859), 200mg QD, p.o., for 24 weeks Letrozole (Femara), 2.5mg QD, p.o., for 24 weeks

ARX788

Arm is closed.

ARX788, 1.5 mg/kg Q3W, IV for 12 weeks

ARX788 + Cemiplimab

Arm is closed.

ARX788, 1.5 mg/kg Q3W, IV for 12 weeks Cemiplimab, 350 mg Q3W, IV for 12 weeks

VV1 + Cemiplimab

Arm is closed.

VV1, 3x10\^9 TCID50 once (day-8), Intra-tumoral injection Cemiplimab, 350 mg Q3W, IV for 12 weeks

Datopotamab deruxtecan

Arm is closed.

Dato-DXd, 6 mg/kg Q3W, IV for 12 weeks

Datopotamab deruxtecan + Durvalumab

Arm is closed.

Dato-DXd, 6 mg/kg Q3W, IV for 12 weeks Durvalumab, 1120 mg Q3W, IV for 12 weeks

Zanidatamab

Zanidatamab: IV Infusion at a 2-tiered flat dose. 1,800mg (<70 kg) and 2400mg (≥70 kg).

Neoadjuvant doing of zanidatamab: The initial dose will be administered on Cycle 1 Day 1, with Cycle 2 Day 1 occurring 14 days thereafter, followed by subsequent dosing every 3 weeks (Q3W) for a total of up to 5 doses in block A, up to 4 doses Block B, up to 5 doses Block C.

Adjuvant dosing of zanidatamab: Administered every 3 weeks (Q3W) for a total of 1 year of HER2 based therapy. The total number of adjuvant weeks will be dependent on the number of weeks of exposure of zanidatamab in Blocks A, B, and C.

Lasofoxifene

Arm is closed.

Lasofoxifene: 5.0 mg QD, p.o., for 24 weeks

Z-endoxifen

Arm is closed.

Z-endoxifen: 10 mg QD, p.o., for 24 weeks

ARV-471

Arm is closed.

ARV-471: 200 mg QD, p.o, for 24 weeks.

ARV-471 + Letrozole

Arm is closed.

ARV-471: 200 mg QD, p.o, for 24 weeks Letrozole: 2.5 mg QD, p.o, for 24 weeks

ARV-471 + Abemaciclib

Arm is closed.

ARV-471: 200 mg QD, p.o, for 24 weeks Abemaciclib: 150 mg BID, p.o, for 24 weeks

Endoxifen + Abemaciclib

Z-endoxifen: 80 mg QD, p.o., for 24 weeks Abemaciclib: 150 mg BID, p.o, for 20 weeks

Rilvegostomig + TDXd

Arm closed to accrual

Rilvegostomig: 750mg IV Q3W for 12 weeks TDXd: 5.4 mg/kg IV Q3W for 12 weeks

Dan222 + Niraparib

Arm is closed.

DAN222: 8mg/m2 IV QW for 12 weeks Niraparib: 200mg QD p.p., 12 weeks

Sarilumab + Cemiplimab + Paclitaxel

Arm is closed to accrual.

Sarilumab: 200mg Subcutaneous injection Q2W for 12 weeks Cemiplimab: 350mg IV Q3W for 12 weeks Paclitaxel: 80 mg/m2 IV QW for 12 weeks

GSK 5733584

Arm is open for accrual.

Route: Intravenous infusion Dosage Form: 4.8 mg/kg intravenous Q3W for injection. Will receive a max of 12 weeks.

GSK 5733584 + Dostarlimab

Arm is open for accrual.

GSK 5733584 Route: Intravenous Infusion Dosage Form: 4.8 mg/kg intravenous Q3W for injection x 12 weeks max.

Dostarlimab Route: Intravenous Infusion Dosage Form: 500 mg fixed dose intravenous Q3W for infusion x 12 weeks max.

Ivonescimab (20mg/kg Q3W)

Strengths to be used in trial:

1. 20 mg/kg IV Q3W monotherapy
2. 20 mg/kg IV Q3W with paclitaxel
3. 20 mg/kg IV Q3W with carboplatin and paclitaxel.

Standard Regimen:

20 mg/kg IV Q3W. Patients in Block A will receive a minimum of 6 weeks a maximum of 12 weeks of Ivonescimab monotherapy in Block A. Patients that have completed Block A, may receive ivonescimab plus paclitaxel or ivonescimab plus paclitaxel plus carboplatin in Block B (depending on subtype).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Won Chang

(855) 866-0505w.chang@quantumleaphealth.org

Heather Prisant

h.prisant@qlhc.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Erica Stringer-Reasor, MD

University of California - Davis, Comprehensive Cancer Center

Recruiting

Davis, California, United States, 95817

Principal Investigator:

Mili Arora, MD

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

800-826-4673

Principal Investigator:

Hope Rugo, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92093-0698

Contacts

858-822-6194

858-822-6194CancerCTO@ucsd.edu

Principal Investigator:

Anne Wallace, MD

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Kristy Watkins, RN

323-865-0452Watkins_K@ccnt.usc.edu

Principal Investigator:

Evanthia Roussos Torres, MD

HOAG Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Principal Investigator:

Chaitali Nangia, MD

University of California San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94115

Contacts

Clinical Research Coordinator

415-443-4296ispycrc@ucsf.edu

Principal Investigator:

Amy Jo Chien, MD

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

720-848-1622

Principal Investigator:

Virgnia Borges, MD

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Trisha Burello, MS

203-737-2848trisha.burrello@yale.edu

Principal Investigator:

Mariya Rozenblit, MD

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Minetta Liu, MD

202-444-3677Liumc@georgetown.edu

Principal Investigator:

Claudine Isaacs, MD

H. Lee Moffitt Cancer Center and Research Institute

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Hyo Heather Han, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Heather Han, MD

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Kevin Kalinsky, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60453

Contacts

773-834-2756

Principal Investigator:

Rita Nanda, MD

Loyola University

Recruiting

Maywood, Illinois, United States, 60153

Contacts

708-327-3102

Principal Investigator:

Kathy S Albain, MD

Herbert-Herman Cancer Center, Sparrow Hospital

Recruiting

Lansing, Michigan, United States, 48912

Principal Investigator:

Brittani Thomas, DO

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

612-626-8487

Principal Investigator:

Douglas Yee, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

507-538-7623

Principal Investigator:

Judy C Boughey, MD

Metro Minnesota Community Oncology Research Consortium, Hennepin County Medical Center

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Principal Investigator:

Satya Bommakanti, MD

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

732-235-7356

Principal Investigator:

Coral Omene, MD, PhD

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Principal Investigator:

Ellis Levine, MD

Laura and Isaac Perlmutter Cancer Center / NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Yannis Karamitas

Yannis.Karamitas@nyulangone.org

Principal Investigator:

Nancy Chan, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Meghana Trivedi, MD

University of Rochester Wilmot Cancer Institute

Recruiting

Rochester, New York, United States, 14642

Contacts

WCICTOResearch@urmc.rochester.edu

Principal Investigator:

Carla Folksm, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Jesus D Anampa

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Angela Howell, MD

336-716-5440anhowell@wakehealth.edu

Principal Investigator:

Marissa Howard-McNatt, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

800-233-2273

Principal Investigator:

Julie Lang, MD

The Ohio State University, Stefanie Spielman Comprehensive Breast Center

Recruiting

Columbus, Ohio, United States, 43212

Principal Investigator:

Nicole Williams, MD

Oregon Health & Science Institute (OHSU)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Brienna Palm

503-494-4438palmb@ohsu.edu

503-494-8573

Principal Investigator:

Alexandra Zimmer, MD

University of Pennsylvania (U Penn)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

215-614-1850

Principal Investigator:

Amy Clark, MD

Sanford Clinical Research

Recruiting

Sioux Falls, South Dakota, United States, 57104

Principal Investigator:

Amy Sanford, MD

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Christos Vaklavas, MD

More Information

Sponsor

QuantumLeap Healthcare Collaborative

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Neoadjuvant
  • Breast
  • Cancer
  • Neoplasm
  • Adaptive
  • pCR
  • Pathologic Complete Response
  • Biomarkers signature
  • MRI Volume
  • Endocrine Therapy
  • Chemotherapy
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by QuantumLeap Healthcare Collaborative on 2026-05-06.