RecruitingNot ApplicableNCT06856200

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


Sponsor

Fudan University

Enrollment

36 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — sirolimus (albumin-bound), palbociclib, and fulvestrant — for women with hormone receptor-positive (HR+), HER2-negative advanced breast cancer. All three drugs target different pathways involved in cancer cell growth. **You may be eligible if...** - You are a woman aged 18 or older who is post-menopausal - You have HR-positive, HER2-negative advanced or metastatic breast cancer confirmed by biopsy - Your doctor believes you are suitable for palbociclib and fulvestrant treatment - Your general health score (ECOG) is 0–1 - You have at least one measurable tumor on imaging (for the dose-expansion stage) **You may NOT be eligible if...** - You were previously diagnosed with HER2-positive breast cancer - Your cancer is in a life-threatening crisis (e.g., large uncontrolled fluid buildup, extensive lung or liver involvement) - You have previously received fulvestrant or drugs targeting the PI3K/AKT/mTOR pathway Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSirolimus (albumin - bound)

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

DRUGPalbociclib

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

DRUGFulvestrant

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.


Locations(1)

Cancer Hospital Affiliated to Fudan University

Shanghai, China

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NCT06856200