Actively Recruiting
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
Led by Fudan University · Updated on 2025-03-04
36
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older regardless of gender; female participants must be post-menopausal
- Histologically or cytologically confirmed HR-positive, HER2-negative advanced breast cancer
- Investigator assesses suitability for palbociclib and fulvestrant treatment
- At least one measurable lesion per RECIST V1.1 criteria (dose-expansion stage only)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- For dose-escalation stage, no restrictions on prior treatments but must be suitable for investigational drugs
- For dose-expansion stage, patients must have received (neo)adjuvant endocrine therapy with evidence of recurrence or progression within 12 months
- No prior systemic chemotherapy for recurrent/metastatic stage except certain exceptions
- No prior CDK4/6 inhibitor treatment for recurrent/metastatic stage with specific exceptions
You will not qualify if you...
- Prior diagnosis of HER2-positive breast cancer
- Unsuitable for endocrine therapy due to life-threatening complications or uncontrolled effusions
- Previous treatment with fulvestrant or PI3K/AKT/mTOR inhibitors
- Uncontrolled third-space fluid accumulation requiring repeated drainage
- History of severe lung diseases or radiation pneumonia needing glucocorticoid treatment
- Chronic gastrointestinal dysfunction like diarrhea grade ≥1, intestinal obstruction, or other significant GI diseases
- Known coagulation disorders or need for anticoagulants affecting injections
- Known hypersensitivity or intolerance to study drugs or LHRH agonists
- History of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases, or organ transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Affiliated to Fudan University
Shanghai, China
Actively Recruiting
Research Team
Z
Zhimin Shao, PhD,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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