deltatrials
Recruiting PHASE2 INTERVENTIONAL 44-arm NCT01042379

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

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

Sponsor: QuantumLeap Healthcare Collaborative

Conditions Angiosarcoma Breast Cancer Breast Neoplasms Breast Tumors Early-stage Breast Cancer HER2-negative Breast Cancer HER2-positive Breast Cancer Hormone Receptor Negative Tumor Hormone Receptor Positive Tumor Locally Advanced Breast Cancer TNBC - Triple-Negative Breast Cancer
Interventions ABT-888 AMG 386 and Trastuzumab AMG 386 with or without Trastuzumab AMG 479 (Ganitumab) plus Metformin ARV-471 ARV-471 + Abemaciclib ARV-471 + Letrozole ARX788 ARX788 + Cemiplimab Amcenestrant Amcenestrant + Abemaciclib Amcenestrant + Letrozole Cemiplimab Cemiplimab plus REGN3767 Dan222 + Niraparib Datopotamab deruxtecan Datopotamab deruxtecan + Durvalumab Durvalumab plus Olaparib Endoxifen + Abemaciclib GSK 5733584 GSK 5733584 + Dostarlimab Ganetespib Lasofoxifene MK-2206 with or without Trastuzumab Neratinib Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab PLX3397 Patritumab and Trastuzumab Pembrolizumab - 4 cycle Pembrolizumab - 8 cycle Pertuzumab and Trastuzumab Rilvegostomig + TDXd SD-101 + Pembrolizumab SGN-LIV1A SYD985 ([vic-]trastuzumab duocarmazine) Sarilumab + Cemiplimab + Paclitaxel Standard Therapy T-DM1 and Pertuzumab Talazoparib plus Irinotecan Trilaciclib with or without trastuzumab + pertuzumab Tucatinib plus trastuzumab and pertuzumab VV1 + Cemiplimab Z-endoxifen Zanidatamab
Updated 29 times since 2017 Last updated: Mar 12, 2026 Started: Mar 1, 2010 Primary completion: Dec 31, 2030 Completion: Dec 31, 2031
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01042379, this PHASE2 trial focuses on Angiosarcoma and Breast Cancer and remains actively recruiting participants. Sponsored by QuantumLeap Healthcare Collaborative, it has been updated 29 times since 2010, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Nov 2017 · 9 months · monthly snapshot~Nov 2017 – ~Feb 2018 · 3 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Jun 2019 · 7 months · monthly snapshot~Jun 2019 – ~Feb 2020 · 8 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Nov 2020 · 8 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~May 2022 · 8 months · monthly snapshot~May 2022 – ~Jul 2022 · 2 months · monthly snapshot~Jul 2022 – ~Dec 2022 · 5 months · monthly snapshot~Dec 2022 – ~Apr 2023 · 4 months · monthly snapshot~Apr 2023 – ~Aug 2023 · 4 months · monthly snapshot~Aug 2023 – ~May 2024 · 9 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Aug 2025 · 9 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 4 months · monthly snapshot

Change History

29 versions recorded

  1. Mar 2026 — Present [monthly]

    Recruiting PHASE2

  2. Feb 2026 — Mar 2026 [monthly]

    Recruiting PHASE2

  3. Sep 2025 — Feb 2026 [monthly]

    Recruiting PHASE2

  4. Aug 2025 — Sep 2025 [monthly]

    Recruiting PHASE2

  5. Nov 2024 — Aug 2025 [monthly]

    Recruiting PHASE2

▶ Show 24 earlier versions

  1. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  3. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

  4. Aug 2023 — May 2024 [monthly]

    Recruiting PHASE2

  5. Apr 2023 — Aug 2023 [monthly]

    Recruiting PHASE2

  6. Dec 2022 — Apr 2023 [monthly]

    Recruiting PHASE2

  7. Jul 2022 — Dec 2022 [monthly]

    Recruiting PHASE2

  8. May 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  9. Sep 2021 — May 2022 [monthly]

    Recruiting PHASE2

  10. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  11. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  12. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

    Phase: PHASE1 → PHASE2

  13. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE1

  14. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

    Phase: PHASE2 → PHASE1

  15. Mar 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

  16. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE2

  17. Jun 2019 — Feb 2020 [monthly]

    Recruiting PHASE2

  18. Nov 2018 — Jun 2019 [monthly]

    Recruiting PHASE2

  19. Jul 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

  20. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  21. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  22. Nov 2017 — Feb 2018 [monthly]

    Recruiting PHASE2

  23. Feb 2017 — Nov 2017 [monthly]

    Recruiting PHASE2

  24. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Mar 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • QuantumLeap Healthcare Collaborative
Data source: QuantumLeap Healthcare Collaborative

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Aurora, United States , Birmingham, United States , Buffalo, United States , Chicago, United States , Cleveland, United States , Columbus, United States , Dallas, United States , Davis, United States , Duarte, United States and 28 more locations