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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuantumLeap Healthcare Collaborative

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard Therapy
  • AMG 386 with or without Trastuzumab
  • AMG 479 (Ganitumab) plus Metformin
  • MK-2206 with or without Trastuzumab
  • AMG 386 and Trastuzumab
  • T-DM1 and Pertuzumab
  • Pertuzumab and Trastuzumab
  • Ganetespib
  • ABT-888
  • Neratinib
  • PLX3397
  • Pembrolizumab - 4 cycle
  • Talazoparib plus Irinotecan
  • Patritumab and Trastuzumab
  • Pembrolizumab - 8 cycle
  • SGN-LIV1A
  • Durvalumab plus Olaparib
  • SD-101 + Pembrolizumab
  • Tucatinib plus trastuzumab and pertuzumab
  • Cemiplimab
  • Cemiplimab plus REGN3767
  • Trilaciclib with or without trastuzumab + pertuzumab
  • SYD985 ([vic-]trastuzumab duocarmazine)
  • Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab
  • Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
  • Amcenestrant
  • Amcenestrant + Abemaciclib
  • Amcenestrant + Letrozole
  • ARX788
  • ARX788 + Cemiplimab
  • VV1 + Cemiplimab
  • Datopotamab deruxtecan
  • Datopotamab deruxtecan + Durvalumab
  • Zanidatamab
  • Lasofoxifene
  • Z-endoxifen
  • ARV-471
  • ARV-471 + Letrozole
  • ARV-471 + Abemaciclib
  • Endoxifen + Abemaciclib
  • Rilvegostomig + TDXd
  • Dan222 + Niraparib
  • Sarilumab + Cemiplimab + Paclitaxel
  • GSK 5733584
  • GSK 5733584 + Dostarlimab
  • Ivonescimab (20mg/kg Q3W)

Treatment groups

5,000 Participants
are divided into 45 treatment groups

45

Treatment groups

See each treatment group below.