Trials / Recruiting
RecruitingNCT06856200
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
An Investigator-initiated Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-02-28
- Primary completion
- 2025-10-01
- Completion
- 2026-06-01
- First posted
- 2025-03-04
- Last updated
- 2025-03-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06856200. Inclusion in this directory is not an endorsement.