A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

Study acronym: NeoB-Cap1
StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Trial sites expanded: 23 → 28 locations
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: details revised at 15 of 19 entries
    • Study description expanded, about 10 words
  2. Re-verified, no change to tracked fieldsv23
  3. Study description shortened, about 110 wordsv22
  4. Primary and study completion moved earlier from Sep 9, 2031 to Apr 14, 2027
    • Study description expanded, about 69 words
    v21
  5. Re-verified, no change to tracked fieldsv20
  6. Study sites: 22 to 23v19
  7. Enrollment reduced: 58 → 20 participants
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 33 → 22 locations
    v18
  8. Site details revised at 4 of 33 sitesv17
  9. Site details revised at 22 of 33 sitesv16
  10. Study sites: 32 to 33v15
  11. Site details revised at 8 of 32 sitesv14
  12. Study sites: 30 to 32
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 27 words
    v13
  13. Study sites: 29 to 30v12
  14. Study sites: 26 to 29v11
  15. Study sites: 25 to 26v10
  16. Study sites: 24 to 25v9
  17. Study sites: 23 to 24v8
  18. Study sites: 13 to 23
    • Eligibility criteria expanded, about 222 words
    • Study description expanded, about 7 words
    v7
  19. Study sites: 14 to 13v6
  20. Study sites: 11 to 14v5
  21. Study sites: 6 to 11v4
  22. Study sites: 3 to 6
    • Start date changed from estimate of Jun 21, 2024 to Aug 14, 2024
    v3
  23. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 16, 2024 to Jun 21, 2024
    • Study sites: 0 to 3
    v2
  24. 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.
Novartis
556 trials monitored
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Breast Cancer
5,466 trials monitored
See 312 trials at risk
In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).
Trial Details
NCT Number NCT06247995
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Neoplasm Metastasis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov