A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer

This study adopts a single-center, open-label, non-randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy. Dose-escalation and dose-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with palbociclib and fulvestrant in this patient population, and to confirm the recommended phase 2 dose (RP2D)

Trial Details

NCT ID
NCT06856200
Phase
NA
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Sirolimus (albumin - bound)
  • Palbociclib
  • Fulvestrant
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • 1\. Subjects should be over 18 years old, regardless of gender. Among them, female patients should be post - menopausal status
  • 2\. Histologically or cytologically confirmed HR - positive, HER2 - negative advanced breast cancer.
  • 3\. The investigator assesses that the patient is suitable for palbociclib and fulvestrant treatment at the current stage.
  • 4\. There is at least one measurable lesion that meets the RECIST V1.1 criteria (only applicable to the dose - expansion stage)

For full eligibility, visit ClinicalTrials.gov.

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