PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Study completion pushed from Aug 24, 2026 to Nov 7, 2027
    • Eligibility criteria expanded, about 115 words
    • Secondary endpoints: details revised at 7 of 17 entries
    • Publications: details revised at 1 of 1 entry
  2. 2 versions Re-verified since Dec 1, 2024, no change to tracked fieldsv31-v32
  3. Study completion date: Apr 30, 2027 to Aug 24, 2026
    • Secondary endpoints: details revised at 1 of 17 entries
    v30
  4. Re-verified, no change to tracked fieldsv29
  5. Secondary endpoints: 16 to 17v28
Show 26 earlier versionsHide 26 earlier versions
  1. Secondary endpoints: 18 to 16v27
  2. Results first posted: Jun 2, 2022
    • Primary endpoints revised (2)
    • Secondary endpoints: 19 to 18
    v26
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 87 to confirmed 84
    • Study sites: 5 to 4
    • Primary completion date changed from estimate of Apr 30, 2022 to Apr 13, 2021
    v25
  4. 3 versions Re-verified since Nov 12, 2019, no change to tracked fieldsv22-v24
  5. Primary completion date: Dec 31, 2020 to Apr 30, 2022
    • Study completion date: Apr 30, 2025 to Apr 30, 2027
    • Collaborators expanded, about 1 word
    v21
  6. Re-verified, no change to tracked fieldsv20
  7. Site details revised at 2 of 5 sitesv19
  8. Enrollment target: 55 to 87v18
  9. Primary completion date: Mar 31, 2017 to Dec 31, 2020
    • Study completion date: Mar 31, 2022 to Apr 30, 2025
    v17
  10. Eligibility criteria shortened, about 90 wordsv16
  11. Primary completion date: Jan 2017 to Mar 31, 2017
    • Study completion date: Feb 2017 to Mar 31, 2022
    • Start date: Jun 2013 to Apr 10, 2013
    • Site contacts updated at 1 of 5 sites
    v15
  12. Re-verified, no change to tracked fieldsv14
  13. Enrollment target: 29 to 55v13 Show 5 more changesShow less
    • Primary endpoints: 1 to 2
    • Interventions: Anastrozole (Drug), Goserelin (Drug), PD0332991 (Drug) to Anastrozole (Drug), Goserelin (Drug), PD0332991 (Drug), Surgery (standard of care) (Procedure), Tumor biopsy (Procedure)
    • Eligibility criteria expanded, about 593 words
    • Secondary endpoints: 10 to 19
    • Study arms: 1 to 3
  14. Primary completion date: Jan 2016 to Jan 2017
    • Study completion date: Feb 2016 to Feb 2017
    v12
  15. Re-verified, no change to tracked fieldsv11
  16. Eligibility criteria expanded, about 563 wordsv10
  17. Study sites: 3 to 5
    • Primary completion date: Jul 2015 to Jan 2016
    • Study completion date: Aug 2015 to Feb 2016
    v9
  18. Study sites: 5 to 3
    • Eligibility criteria expanded, about 23 words
    v8
  19. Site details revised at 2 of 5 sitesv7
  20. Primary endpoint revised
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints: 9 to 10
    • Study sites revised (5)
    v6
  21. Primary endpoint revised
    • Eligibility criteria expanded, about 107 words
    • Secondary endpoints: 4 to 9
    v5
  22. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Mar 2013 to Jun 2013
    • Secondary endpoints: 5 to 4
    • Site details revised at 5 of 5 sites
    • Eligibility criteria shortened, about 5 words
  23. Study sites: 4 to 5v3 Show 6 more changesShow less
    • Primary completion date: Jun 2015 to Jul 2015
    • Study completion date: Jul 2015 to Aug 2015
    • Start date: Feb 2013 to Mar 2013
    • Interventions: PD0332991+ Anastrozole (Drug) to Anastrozole (Drug), Goserelin (Drug), PD0332991 (Drug)
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 3 to 5
  24. Study sites: 8 to 4
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 3 entries
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A Phase II study to investigate the potential utility of PD 0332991 in the treatment of early stage ER+ Human epidermal growth factor receptor 2 (HER2)- breast cancer, to investigate whether the combination of PD 0332991 and anastrozole is able to: 1) improve the pathologic complete response rate when compared to the historical control of single agent aromatase inhibitors, 2) result in fewer patients with on therapy Ki67\>10% compared to historical control.
Trial Details
NCT Number NCT01723774
Lead Sponsor Washington University School of Medicine
Collaborators: Pfizer
Conditions
(from sponsor)		 Breast Neoplasms
Related terms Breast Neoplasms
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov