deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 1-arm NCT01334021

Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer

Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)

Sponsor: M.D. Anderson Cancer Center

Conditions Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Invasive Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8
Interventions Biopsy Conventional Surgery Genetic Testing
Updated 24 times since 2017 Last updated: Mar 5, 2026 Started: May 31, 2011 Primary completion: Dec 31, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01334021, this PHASE2 trial focuses on Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8 and remains ongoing. Sponsored by M.D. Anderson Cancer Center, it has been updated 24 times since 2011, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Jun 2017 · 5 months · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Dec 2017 · 4 months · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Oct 2019 · 10 months · monthly snapshot~Oct 2019 – ~Apr 2020 · 6 months · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Mar 2022 · 6 months · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Oct 2023 · 13 months · monthly snapshot~Oct 2023 – ~Apr 2024 · 6 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~May 2025 · 7 months · monthly snapshot~May 2025 – ~Oct 2025 · 5 months · monthly snapshot~Oct 2025 – ~Mar 2026 · 5 months · monthly snapshot~Mar 2026 – present · 5 months · monthly snapshot

Change History

24 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE2

  2. Oct 2025 — Mar 2026 [monthly]

    Active Not Recruiting PHASE2

  3. May 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Oct 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE2

  5. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE2

▶ Show 19 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  3. Oct 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2022 — Oct 2023 [monthly]

    Active Not Recruiting PHASE2

  5. Mar 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

  6. Sep 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE2

  7. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2

  8. Aug 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  9. Apr 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

  10. Oct 2019 — Apr 2020 [monthly]

    Active Not Recruiting PHASE2

  11. Dec 2018 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2

    Phase: None → PHASE2

  12. Jun 2018 — Dec 2018 [monthly]

    Active Not Recruiting

    Status: Recruiting → Active Not Recruiting

  13. May 2018 — Jun 2018 [monthly]

    Recruiting

  14. Apr 2018 — May 2018 [monthly]

    Recruiting

    Phase: NA → None

  15. Mar 2018 — Apr 2018 [monthly]

    Recruiting NA

  16. Dec 2017 — Mar 2018 [monthly]

    Recruiting NA

  17. Aug 2017 — Dec 2017 [monthly]

    Recruiting NA

  18. Jun 2017 — Aug 2017 [monthly]

    Recruiting NA

  19. Jan 2017 — Jun 2017 [monthly]

    Recruiting NA

    First recorded

May 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

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

Study Locations