Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy

NCT06957379 | Active Not Recruiting Phase 2

• 1 other identifier: HB1901-005
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, open, non-randomized phase II clinical trial consisting of a safety introduction phase followed by a single-arm phase 2 phase. This phase II trial enrolled patients with HR+/HER2- advanced breast cancer who had failed aromatase inhibitor (AI)/fulvestrant ± CDK4/6i. Pts failing prior AI ± CDK4/6i received nab-Sirolimus + fulvestrant, while those failing fulvestrant ± CDK4/6i received nab-Sirolimus + AI.

Conditions

HR+/HER2- Advanced/Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Up to ~24 months

Secondary Outcomes (6)

• Disease Control Rate (DCR）

  Up to ~36 months

• Duration of Response (DoR)

  Up to ~24 months

• Progression-Free Survival (PFS)

  Up to ~24 months

• Overall Survivial (OS)

  Up to ~24 months

• Safety and Tolerability :the incidence and severity of Treatment Emergent Adverse Events（TEAEs）and Treatment-Related Adverse Events（TRAEs）

  Up to ~24 months

Study Arms (1)

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant or Aromatase Inhibitor

EXPERIMENTAL

A: Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant; B: Sirolimus for Injection (Albumin-bound) Combined with Exemestane，or Letrozole，or Anastrozole.

Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant; Drug: Sirolimus for Injection (Albumin-bound)

Interventions

Letrozole DRUG

Oral administration at a dose of 2.5 mg once daily for a 4-week cycle

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant or Aromatase Inhibitor

Anastrozole DRUG

Oral administration at a dose of 1 mg once daily for a 4-week cycle

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant or Aromatase Inhibitor

Exemestane DRUG

Oral administration at a dose of 25 mg once daily with a meal every 4 weeks

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant or Aromatase Inhibitor

Fulvestrant DRUG

Fulvestrant: IM injection, 500 mg, on day 1 and day 15 of Cycle 1, and then on day 1 of each cycle thereafter, 4 weeks per treatment cycle

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant or Aromatase Inhibitor

Sirolimus for Injection (Albumin-bound) DRUG

IV infusion, every 2 weeks, 4 weeks per treatment cycle

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant or Aromatase Inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18 or above, regardless of gender; female patients must be postmenopausal, or premenopausal/perimenopausal.
• \. Pathologically confirmed HR+, HER2- breast cancer.
• \. Patients who have failed prior treatment with AI or fulvestrant with or without CDK4/6 inhibitors.
• \. No more than 3 lines of chemotherapy for inoperable locally advanced or metastatic disease.
• \. At least one measurable lesion according to RECIST 1.1 criteria. Patients with bone lesions only may be eligible.
• \. ECOG performance status score of 0-1.
• \. Investigator-assessed life expectancy ≥3 months.
• \. Adequate organ and bone marrow function.
• \. Baseline fasting serum triglyceride \<300mg/dL or 3.42mmol/L, fasting serum cholesterol \<350mg/dL or 9.07mmol/L
• \. The baseline fasting plasma glucose (FPG) ˂ 7.8 mmol/L and glycosylated hemoglobin (HbA1c) ˂ 8%
• \. Premenopausal female patients using LHRH agonists to suppress ovarian function must agree to use two acceptable forms of highly effective contraception during the study and for 6 months after stopping study treatment; female patients of childbearing potential must have a negative pregnancy test before starting study treatment and must not be breastfeeding.
• \. Male patients must agree to use barrier contraception (i.e., condoms) during the study and for 6 months after stopping study treatment; for men with future fertility plans, sperm freezing is recommended before starting study treatment.
• \. Participants must provide informed consent before the trial and voluntarily sign the written ICF.

You may not qualify if:

• \. Previous pathological diagnosis of HER2-positive breast cancer.
• \. Patients judged by the investigator to be unsuitable for endocrine therapy.
• \. Patients who have previously received PI3K/AKT/mTOR inhibitors.
• \. Received chemotherapy, radiotherapy, biological therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before randomization.
• \. Received other unapproved investigational drugs within 4 weeks before randomization.
• \. Underwent major surgery within 4 weeks before randomization or has not fully recovered from any previous invasive procedures.
• \. Received systemic glucocorticoids (prednisone \>10 mg/day or equivalent) or other immunosuppressive treatments within 2 weeks before randomization.
• \. Had an infection within 2 weeks before randomization requiring systemic (oral or IV) anti-infective treatment (uncomplicated urinary tract infections or upper respiratory tract infections excluded).
• \. Received inactivated or live attenuated vaccines or COVID-19 vaccines within 4 weeks before randomization.
• \. Used strong inhibitors or inducers of CYP3A4 hepatic metabolic enzymes within 2 weeks before randomization or still need to continue using such drugs.
• \. Diagnosed with other malignancies within 5 years before randomization.
• \. Suffering from severe cardiovascular or cerebrovascular diseases.
• \. Adverse reactions from previous anti-tumor treatments have not recovered to CTCAE 5.0 grade ≤1.
• \. Active leptomeningeal disease or poorly controlled central nervous system metastases.
• \. Presence of pleural/abdominal effusion or pericardial effusion with clinical symptoms or requiring symptomatic treatment.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Anastrozole; exemestane; Fulvestrant; Sirolimus; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Macrolides; Lactones; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: February 29, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

CN (1)