Advanced Breast CancerPhase 1NCT06941142
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
A Phase 1 study testing Sirolimus (albumin - bound), Palbociclib tablet and Fulvestrant injection in people with Advanced Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This study adopts multicenter/randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Sirolimus (albumin - bound), Palbociclib tablet and Fulvestrant injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2025to Jun 2028
- Phase
- Phase 1
- 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. Subjects should be over 18 years old, regardless of gender.
- 2. Histologically or cytologically confirmed HR - positive, HER2 - negative advanced breast cancer.
- 3. For patients in the dose escalation stage, there are no limitation on previous treatments. The investigator must assess whether the patients are currently suitable for enrollment and eligible to receive the study drug treatment. For patients in the dose expansion stage need to meet the following criteria: The patient has received (neo)adjuvant endocrine therapy and has evidence of radiographic recurrence or progression during the treatment or within 12 months after the end of the treatment. The patient is allowed to receive no more than one line of systemic chemotherapy at the recurrence and metastasis setting. The patient has not received CDK4/6 inhibitor treatment at the recurrence and metastasis setting.
- 4. At least one measurable lesion meeting RECIST V1.1 criteria (patients with bone-only metastases may be enrolled in the dose escalation stage).
- 5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 - 1.
- 6. The predicted survival time is more than 6 months.
- 7. The major organ functions must meet the protocol criteria within 7 days prior to treatment.
- 8. Voluntarily participate in this clinical study, understand the research procedures, and be able to sign the written informed consent form.
Who cannot join
- 1. Previously diagnosed with HER2 - positive breast cancer through pathological examination.
- 2. Patients deemed by the investigator as unsuitable for endocrine therapy (e.g., those with visceral crisis posing immediate life-threatening risks in the short term, including: uncontrolled massive effusions [pleural, pericardial, or peritoneal], pulmonary lymphangitic carcinomatosis, or hepatic involvement >50%).
- 3. Patients who have previously received treatment with fulvestrant or inhibitors such as PI3K/AKT/mTOR.
- 4. Patients with uncontrolled third-space fluid accumulation (e.g., pericardial effusion, pleural effusion, or ascites) requiring repeated drainage or other therapeutic interventions, and deemed ineligible for enrollment by investigators.
- 5. Patients with a history of severe lung diseases, such as interstitial lung disease and/or pneumonia, or pulmonary hypertension, or radiation pneumonia requiring glucocorticoid treatment.
- 6. Patients with chronic gastrointestinal dysfunction mainly manifested as diarrhea, such as Crohn's disease, ulcerative colitis, malabsorption, or diarrhea of grade ≥ 1; intestinal obstruction, or other gastrointestinal diseases deemed clinically significant by investigators.
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- 7. Patients with known coagulation disorders such as bleeding tendency; or those who need to use anticoagulants, which may affect the intramuscular injection of fulvestrant or the use of LHRH agonists.
- 8. Patients with known hypersensitivity or intolerance to any component of the investigational drug(s), their excipients, or LHRH agonists (if applicable).
- 9. Patients with a history of autoimmune diseases (except tuberous sclerosis), immunodeficiency diseases (including positive HIV test), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Ib/III Study to Evaluate the Safety and Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer
This study adopts multicenter/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.
- Conditions
- Advanced Breast Cancer
- Being tested
- Sirolimus (albumin - bound), Palbociclib tablet, Fulvestrant injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus (albumin - bound)Drug
Dose escalation, intravenous infusion
Palbociclib tabletDrug
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
Fulvestrant injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and expansion | Experimental | Not described Receives: Drug: Sirolimus (albumin - bound); Drug: Palbociclib tablet; Drug: Fulvestrant injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence and frequency of adverse events (AE)
Measured: up to 2 years
dose-limiting toxicities (DLT)
Measured: up to 1 year
The recommended phase 3 dose
Measured: up to 2 years
The occurrence and frequency of serious adverse events (SAE)
Measured: up to 2 years
Overall reponse rate（ORR）
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941142
- Sponsor's protocol ID
- HB1901-009
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 23 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ib/III Study to Evaluate the Safety and Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06941142
- Acronym / sponsor ID
- HB1901-009
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 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.
This study adopts multicenter/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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and expansion | Experimental | Drug: Sirolimus (albumin - bound), Drug: Palbociclib tablet, Drug: Fulvestrant injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Subjects should be over 18 years old, regardless of gender.
- 2. Histologically or cytologically confirmed HR - positive, HER2 - negative advanced breast cancer.
- 3. For patients in the dose escalation stage, there are no limitation on previous treatments. The investigator must assess whether the patients are currently suitable for enrollment and eligible to receive the study drug treatment. For patients in the dose expansion stage need to meet the following criteria: The patient has received (neo)adjuvant endocrine therapy and has evidence of radiographic recurrence or progression during the treatment or within 12 months after the end of the treatment. The patient is allowed to receive no more than one line of systemic chemotherapy at the recurrence and metastasis setting. The patient has not received CDK4/6 inhibitor treatment at the recurrence and metastasis setting.
- 4. At least one measurable lesion meeting RECIST V1.1 criteria (patients with bone-only metastases may be enrolled in the dose escalation stage).
- 5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 - 1.
Key exclusion criteria (9 listed)
- 1. Previously diagnosed with HER2 - positive breast cancer through pathological examination.
- 2. Patients deemed by the investigator as unsuitable for endocrine therapy (e.g., those with visceral crisis posing immediate life-threatening risks in the short term, including: uncontrolled massive effusions [pleural, pericardial, or peritoneal], pulmonary lymphangitic carcinomatosis, or hepatic involvement >50%).
- 3. Patients who have previously received treatment with fulvestrant or inhibitors such as PI3K/AKT/mTOR.
- 4. Patients with uncontrolled third-space fluid accumulation (e.g., pericardial effusion, pleural effusion, or ascites) requiring repeated drainage or other therapeutic interventions, and deemed ineligible for enrollment by investigators.
- 5. Patients with a history of severe lung diseases, such as interstitial lung disease and/or pneumonia, or pulmonary hypertension, or radiation pneumonia requiring glucocorticoid treatment.
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 (albumin - bound)Dose escalation, intravenous infusion | Drug | Dose escalation and expansion |
| Palbociclib tabletThe 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 | Drug | Dose escalation and expansion |
| Fulvestrant injectionThe 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. | Drug | Dose escalation and expansion |
Primary outcome
The occurrence and frequency of adverse events (AE)
Time frame: up to 2 years
dose-limiting toxicities (DLT)
Time frame: up to 1 year
The recommended phase 3 dose
Time frame: up to 2 years
The occurrence and frequency of serious adverse events (SAE)
Time frame: up to 2 years
Overall reponse rate（ORR）
Time frame: up to 2 years
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 23 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sirolimus (albumin - bound), Palbociclib tablet and Fulvestrant injection in people with Advanced Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 8 inclusion and 9 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The occurrence and frequency of adverse events (AE) (time frame: up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2025.