Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors

NCT06929325 | Not Yet Recruiting Phase 3

• 1 other identifier: HB1901-008
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.

Conditions

HR+/HER2- Advanced/Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival（PFS）

  Up to ~24 months

Secondary Outcomes (7)

• Overall Survival（OS）

  Up to ~36 months

• Overall response rate（ORR）

  Up to ~24 months

• Clinical benefit rate（CBR）

  Up to ~24 months

• Disease control rate（DCR）

  Up to ~24 months

• Duration of Response（DOR）

  Up to ~24 months

Study Arms (2)

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant

EXPERIMENTAL

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

Placebo Combined with Fulvestrant

ACTIVE COMPARATOR

Drug: Fulvestrant Injection; Drug: Placebo for Sirolimus for Injection (Albumin-bound)

Interventions

Sirolimus for Injection (Albumin-bound) DRUG

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

Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant

Fulvestrant Injection DRUG

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

Placebo Combined with Fulvestrant; Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant

Placebo for Sirolimus for Injection (Albumin-bound) DRUG

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

Placebo Combined with Fulvestrant

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.
• \. Locally advanced or metastatic breast cancer, not suitable for curative surgery or radiotherapy, and no current clinical indication for chemotherapy.
• \. Previously received at least one, up to two lines of systemic therapy (including at least one line of endocrine therapy combined with CDK4/6 inhibitor therapy).
• \. At least one measurable lesion according to RECIST 1.1 criteria.
• \. Willing to provide tumor and/or blood samples for biomarker testing; if unable to provide, subject to investigator and sponsor evaluation for eligibility.
• \. ECOG performance status score of 0-1.
• \. Investigator-assessed life expectancy ≥6 months.
• \. Adequate organ and bone marrow function.
• \. 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 2 years after stopping study treatment; female patients of childbearing potential must have a negative pregnancy blood 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 2 years 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, fulvestrant, or other ER-targeted therapies (including oral SERDs, ER protein degraders PROTAC, etc.).
• \. 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)

Clinical Trials Information Group

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sirolimus; Injections; Fulvestrant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (1)