MedTrace Logo

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

NCT06856200 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-04

No results posted yet for this study

Summary

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)

Conditions

  • Advanced HR - Positive, HER2 - Negative Breast Cancer
  • Resistant to (Neo)Adjuvant Endocrine Therapy

Interventions

DRUG

Sirolimus (albumin - bound)

Sirolimus (albumin - bound): Dose escalation, intravenous infusion

DRUG

Palbociclib

Palbociclib: the dosage is 125 mg, orally once a day. taken continuously for three weeks followed by a one - week break, with a treatment cycle of four weeks

DRUG

Fulvestrant

Fulvestrant: the dosage is 500 mg, intramuscular injection. It is given on the 1st and 15th days of the first cycle, with a treatment cycle of four weeks. After that, it is administered once every four weeks.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-10-31
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856200 on ClinicalTrials.gov