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HR+/HER2- Advanced/Metastatic Breast CancerPhase 2NCT06957379

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

A Phase 2 study testing Letrozole, Anastrozole and Exemestane in people with HR+/HER2- Advanced/Metastatic Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Letrozole, Anastrozole and Exemestane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
29 Feb 2024to Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Aged 18 or above, regardless of gender; female patients must be postmenopausal, or premenopausal/perimenopausal.
  • 2. Pathologically confirmed HR+, HER2- breast cancer.
  • 3. Patients who have failed prior treatment with AI or fulvestrant with or without CDK4/6 inhibitors.
  • 4. No more than 3 lines of chemotherapy for inoperable locally advanced or metastatic disease.
  • 5. At least one measurable lesion according to RECIST 1.1 criteria. Patients with bone lesions only may be eligible.
  • 6. ECOG performance status score of 0-1.
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  • 7. Investigator-assessed life expectancy ≥3 months.
  • 8. Adequate organ and bone marrow function.
  • 9. Baseline fasting serum triglyceride <300mg/dL or 3.42mmol/L, fasting serum cholesterol <350mg/dL or 9.07mmol/L
  • 10. The baseline fasting plasma glucose (FPG) ˂ 7.8 mmol/L and glycosylated hemoglobin (HbA1c) ˂ 8%
  • 11. 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.
  • 12. 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.
  • 13. Participants must provide informed consent before the trial and voluntarily sign the written ICF.

Who cannot join

  • 1. Previous pathological diagnosis of HER2-positive breast cancer.
  • 2. Patients judged by the investigator to be unsuitable for endocrine therapy.
  • 3. Patients who have previously received PI3K/AKT/mTOR inhibitors.
  • 4. Received chemotherapy, radiotherapy, biological therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before randomization.
  • 5. Received other unapproved investigational drugs within 4 weeks before randomization.
  • 6. Underwent major surgery within 4 weeks before randomization or has not fully recovered from any previous invasive procedures.
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  • 7. Received systemic glucocorticoids (prednisone >10 mg/day or equivalent) or other immunosuppressive treatments within 2 weeks before randomization.
  • 8. 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).
  • 9. Received inactivated or live attenuated vaccines or COVID-19 vaccines within 4 weeks before randomization.
  • 10. Used strong inhibitors or inducers of CYP3A4 hepatic metabolic enzymes within 2 weeks before randomization or still need to continue using such drugs.
  • 11. Diagnosed with other malignancies within 5 years before randomization.
  • 12. Suffering from severe cardiovascular or cerebrovascular diseases.
  • 13. Adverse reactions from previous anti-tumor treatments have not recovered to CTCAE 5.0 grade ≤1.
  • 14. Active leptomeningeal disease or poorly controlled central nervous system metastases.
  • 15. Presence of pleural/abdominal effusion or pericardial effusion with clinical symptoms or requiring symptomatic treatment.
  • 16. Known bleeding tendency (constitution) or coagulation disorders.
  • 17. History of severe lung diseases such as interstitial lung disease and/or pneumonia, pulmonary hypertension, or radiation pneumonitis requiring glucocorticoid treatment.
  • 18. Known hypersensitivity or intolerance to any component of the study drug or its excipients, or LHRH agonists (if applicable).
  • 19. History of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or organ transplant history.
  • 20. Active HBV, HCV, syphilis, or tuberculosis infection.
  • 21. Other conditions judged by the investigator to be unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase II Clinical Trial of the Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for the Treatment of HR-positive, HER2-negative Patients With Advanced Breast Cancer Who Have Failed Standard Therapy

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.

Being tested
Letrozole, Anastrozole, Exemestane, Fulvestrant, Sirolimus for Injection (Albumin-bound)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LetrozoleDrug

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

  • AnastrozoleDrug

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

  • ExemestaneDrug

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

  • FulvestrantDrug

    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)Drug

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

Study groups in NCT06957379
Study groupRoleWhat they receive
Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant or Aromatase InhibitorExperimentalA: Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant; B: Sirolimus for Injection (Albumin-bound) Combined with Exemestane，or Letrozole，or Anastrozole.
Receives: Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane; Drug: Fulvestrant; Drug: Sirolimus for Injection (Albumin-bound)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Measured: Up to ~24 months

Secondary outcomes (6)

  1. Disease Control Rate (DCR）

    Measured: Up to ~36 months

  2. Duration of Response (DoR)

    Measured: Up to ~24 months

  3. Progression-Free Survival (PFS)

    Measured: Up to ~24 months

  4. Overall Survivial (OS)

    Measured: Up to ~24 months

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

    Measured: Up to ~24 months

  6. PK parameter: the concentration of sirolimus

    Measured: Up to ~24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start29 Feb 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06957379
Sponsor's protocol ID
HB1901-005
Status last verified
Apr 2025
First submitted
26 Apr 2025
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letrozole, Anastrozole and Exemestane in people with HR+/HER2- Advanced/Metastatic Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to ~24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06957379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.

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