HR+/HER2- Advanced/Metastatic Breast CancerPhase 3NCT06929325

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

A Phase 3 study testing Sirolimus for Injection (Albumin-bound) and Fulvestrant Injection in people with HR+/HER2- Advanced/Metastatic Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HR+/HER2- Advanced/Metastatic Breast Cancer
What is being tested?: Sirolimus for Injection (Albumin-bound) and Fulvestrant Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 312 participants
Where: 1 siteChina
Study dates: Apr 2025to Dec 2027
Phase: Phase 3
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. Locally advanced or metastatic breast cancer, not suitable for curative surgery or radiotherapy, and no current clinical indication for chemotherapy.
4. 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).
5. At least one measurable lesion according to RECIST 1.1 criteria.
6. Willing to provide tumor and/or blood samples for biomarker testing; if unable to provide, subject to investigator and sponsor evaluation for eligibility.

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7. ECOG performance status score of 0-1.
8. Investigator-assessed life expectancy ≥6 months.
9. Adequate organ and bone marrow function.
10. 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.
11. 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.
12. 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, fulvestrant, or other ER-targeted therapies (including oral SERDs, ER protein degraders PROTAC, etc.).
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. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site

Clinical Trials Information Group
Shijiazhuang, Hebei
Clinical Trials Information Group officer, 86-0311-69085587, ctr-contact@cspc.cn

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant Versus Placebo Combined With Fulvestrant in HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Patients After Prior CDK4/6 Inhibitor Treatment.

Conditions: HR+/HER2- Advanced/Metastatic Breast Cancer
Being tested: Sirolimus for Injection (Albumin-bound), Fulvestrant Injection, Placebo for 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.

Sirolimus for Injection (Albumin-bound)Drug
IV infusion, every 2 weeks, 4 weeks per treatment cycle
Fulvestrant InjectionDrug
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 for Sirolimus for Injection (Albumin-bound)Drug
IV infusion, every 2 weeks, 4 weeks per treatment cycle

Study groups in NCT06929325
Study group	Role	What they receive
Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant	Experimental	Not described Receives: Drug: Sirolimus for Injection (Albumin-bound); Drug: Fulvestrant Injection
Placebo Combined with Fulvestrant	Active comparator	Not described Receives: Drug: Fulvestrant Injection; Drug: Placebo for Sirolimus for Injection (Albumin-bound)

What is being measured

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

Progression-free Survival（PFS）
Measured: Up to ~24 months

Secondary outcomes (7)

Overall Survival（OS）
Measured: Up to ~36 months
Overall response rate（ORR）
Measured: Up to ~24 months
Clinical benefit rate（CBR）
Measured: Up to ~24 months
Disease control rate（DCR）
Measured: Up to ~24 months
Duration of Response（DOR）
Measured: Up to ~24 months
Safety and Tolerability：the incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: Up to ~24 months
PK metrics：plasma 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.

Apr 2025Dec 2027

First posted16 Apr 2025
Study startApr 2025 (estimated)
Primary completionOct 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HR+/HER2- Advanced/Metastatic Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 312 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06929325
Sponsor's protocol ID: HB1901-008
Status last verified: Apr 2025
First submitted: 8 Apr 2025
Last updated: 16 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant Versus Placebo Combined With Fulvestrant in HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Patients After Prior CDK4/6 Inhibitor Treatment.
ClinicalTrials.gov ID: NCT06929325
Acronym / sponsor ID: HB1901-008
Conditions: HR+/HER2- Advanced/Metastatic Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 312 participants (estimated)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: Apr 2025 (estimated)
Primary completion: Oct 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 16 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

1. Aged 18 or above, regardless of gender; female patients must be postmenopausal, or premenopausal/perimenopausal.
2. Pathologically confirmed HR+, HER2- breast cancer.
3. Locally advanced or metastatic breast cancer, not suitable for curative surgery or radiotherapy, and no current clinical indication for chemotherapy.
4. 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).
5. At least one measurable lesion according to RECIST 1.1 criteria.

Key exclusion criteria (21 listed)

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, fulvestrant, or other ER-targeted therapies (including oral SERDs, ER protein degraders PROTAC, etc.).
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sirolimus for Injection (Albumin-bound)IV infusion, every 2 weeks, 4 weeks per treatment cycle	Drug	Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant
Fulvestrant InjectionIM 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	Drug	Placebo Combined with Fulvestrant, Sirolimus for Injection (Albumin-bound) Combined with Fulvestrant
Placebo for Sirolimus for Injection (Albumin-bound)IV infusion, every 2 weeks, 4 weeks per treatment cycle	Drug	Placebo Combined with Fulvestrant

Primary outcome

Progression-free Survival（PFS）
Time frame: Up to ~24 months

7 secondary outcomes

Overall Survival（OS）
Time frame: Up to ~36 months
Overall response rate（ORR）
Time frame: Up to ~24 months
Clinical benefit rate（CBR）
Time frame: Up to ~24 months
Disease control rate（DCR）
Time frame: Up to ~24 months
Duration of Response（DOR）
Time frame: Up to ~24 months
Safety and Tolerability：the incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to ~24 months
PK metrics：plasma concentration of sirolimus
Time frame: Up to ~24 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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: opening soon, as of the sponsor's last update on 16 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival（PFS） (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 NCT06929325.

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 16 Apr 2025.