Advanced HR - Positive, HER2 - Negative Breast CancerNCT06856200
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
A study testing Sirolimus (albumin - bound), Palbociclib and Fulvestrant in people with Advanced HR - Positive, HER2 - Negative Breast Cancer and Resistant to (Neo)Adjuvant Endocrine Therapy, run by Fudan University at 1 site in China.
Trial summary
This study adopts a single-center, open-label, non-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 HR - Positive, HER2 - Negative Breast Cancer, Resistant to (Neo)Adjuvant Endocrine Therapy
- What is being tested?
- Sirolimus (albumin - bound), Palbociclib and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to Jun 2026
- Phase
- Interventional
- 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. Among them, female patients should be post - menopausal status
- 2. Histologically or cytologically confirmed HR - positive, HER2 - negative advanced breast cancer.
- 3. The investigator assesses that the patient is suitable for palbociclib and fulvestrant treatment at the current stage.
- 4. There is at least one measurable lesion that meets the RECIST V1.1 criteria (only applicable to the dose - expansion stage)
- 5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 - 1.
- 6. For patients in the dose - escalation stage, there are no restrictions on previous treatments. The investigator needs to determine that the patient is suitable for enrollment in the study and receiving the investigational drugs at the current stage. For patients in the dose - expansion stage, the following criteria must be met:
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- The patient has received (neo)adjuvant endocrine therapy (either as a single agent or in combination). There should be imaging evidence of breast cancer recurrence or progression during or within 12 months after the completion of (neo)adjuvant endocrine therapy (tamoxifen, AI, or oral SERD).
- Patients in the recurrent or metastatic stage have not received systemic chemotherapy. (Note 1: A chemotherapy regimen that is terminated due to toxicity during the first cycle or after the completion of treatment, and there is no clinical or imaging evidence of disease progression at the start of subsequent treatment, is not counted as a line of treatment. Note 2: Adjuvant and neoadjuvant chemotherapy are not classified as lines of treatment for ABC. Note 3: Antibody - drug conjugates are classified as chemotherapy)
- Patients in the recurrent or metastatic stage have not received CDK4/6 inhibitor treatment. (Note 1: It is allowed that the patient has received CDK4/6i during (neo)adjuvant therapy, and there is a disease - free interval of at least 12 months (i.e., at least 12 months between the last day of CDK4/6i treatment and the date of recurrence). In addition, drug replacement in patients without disease progression does not count as a new line of treatment)
Who cannot join
- 1. The patient was previously diagnosed with HER2 - positive breast cancer through pathological examination.
- 2. Patients who are judged by the investigator as unsuitable for endocrine therapy (e.g., patients with visceral crisis at immediate risk of life - threatening complications in the short term, including those with a large amount of uncontrolled effusion (pleural, pericardial, and abdominal), lymphangitis carcinomatosa of the lung, or patients with liver involvement > 50%).
- 3. Patients who have previously received treatment with fulvestrant or inhibitors such as PI3K/AKT/mTOR.
- 4. Patients with third - space fluid accumulation (such as pericardial effusion, pleural effusion, and ascites) that requires repeated drainage or other treatments but remains uncontrollable, and are judged by the investigator as unsuitable for enrollment.
- 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 judged to be clinically significant by the investigator.
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- 7. Patients with known coagulation disorders such as bleeding tendency; or patients 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 all investigational drugs or their excipients, or any components of LHRH agonists (if applicable).
- 9. Patients with a history of autoimmune diseases (except tuberous sclerosis), a history of immunodeficiency diseases (including positive HIV test), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Affiliated to Fudan University
Shanghai
zuo Wenjia, +86 18018678485
About this study
Official title: An Investigator-initiated Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer
This study adopts a single-center, open-label, non-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, and to confirm the recommended phase 2 dose (RP2D)
- Conditions
- Advanced HR - Positive, HER2 - Negative Breast Cancer, Resistant to (Neo)Adjuvant Endocrine Therapy
- Being tested
- Sirolimus (albumin - bound), Palbociclib, Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus (albumin - bound)Drug
Sirolimus (albumin - bound): Dose escalation, intravenous infusion
PalbociclibDrug
Palbociclib: 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
FulvestrantDrug
Fulvestrant: 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; Drug: Fulvestrant |
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: At the end of Cycle 9 (each cycle is 28 days)
dose - limiting toxicities (DLT)
Measured: At the end of Cycle 9 (each cycle is 28 days)
The recommended phase 2 dose
Measured: At the end of Cycle 9 (each cycle is 28 days)
4. serious adverse events (SAE)
Measured: At the end of Cycle 9 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start28 Feb 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HR - Positive, HER2 - Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856200
- Sponsor's protocol ID
- HB1901-007
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 4 Mar 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06856200
- Acronym / sponsor ID
- HB1901-007
- Conditions
- Advanced HR - Positive, HER2 - Negative Breast Cancer, Resistant to (Neo)Adjuvant Endocrine Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Mar 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 a single-center, open-label, non-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, and to confirm the recommended phase 2 dose (RP2D)
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, Drug: Fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Subjects should be over 18 years old, regardless of gender. Among them, female patients should be post - menopausal status
- 2. Histologically or cytologically confirmed HR - positive, HER2 - negative advanced breast cancer.
- 3. The investigator assesses that the patient is suitable for palbociclib and fulvestrant treatment at the current stage.
- 4. There is at least one measurable lesion that meets the RECIST V1.1 criteria (only applicable to the dose - expansion stage)
- 5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 - 1.
Key exclusion criteria (9 listed)
- 1. The patient was previously diagnosed with HER2 - positive breast cancer through pathological examination.
- 2. Patients who are judged by the investigator as unsuitable for endocrine therapy (e.g., patients with visceral crisis at immediate risk of life - threatening complications in the short term, including those with a large amount of uncontrolled effusion (pleural, pericardial, and abdominal), lymphangitis carcinomatosa of the lung, or patients with liver involvement > 50%).
- 3. Patients who have previously received treatment with fulvestrant or inhibitors such as PI3K/AKT/mTOR.
- 4. Patients with third - space fluid accumulation (such as pericardial effusion, pleural effusion, and ascites) that requires repeated drainage or other treatments but remains uncontrollable, and are judged by the investigator as unsuitable for enrollment.
- 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)Sirolimus (albumin - bound): Dose escalation, intravenous infusion | Drug | Dose escalation and expansion |
| PalbociclibPalbociclib: 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 | Drug | Dose escalation and expansion |
| FulvestrantFulvestrant: 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. | Drug | Dose escalation and expansion |
Primary outcome
The occurrence and frequency of adverse events (AE)
Time frame: At the end of Cycle 9 (each cycle is 28 days)
dose - limiting toxicities (DLT)
Time frame: At the end of Cycle 9 (each cycle is 28 days)
The recommended phase 2 dose
Time frame: At the end of Cycle 9 (each cycle is 28 days)
4. serious adverse events (SAE)
Time frame: At the end of Cycle 9 (each cycle is 28 days)
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 4 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus (albumin - bound), Palbociclib and Fulvestrant in people with Advanced HR - Positive, HER2 - Negative Breast Cancer and Resistant to (Neo)Adjuvant Endocrine Therapy, run by Fudan University 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 9 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: looking for participants now, as of the sponsor's last update on 4 Mar 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.
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 Zhimin Shao, PhD,MD (+086 64175590 ext. 88807, zhimingshao@yahoo.com), 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: At the end of Cycle 9 (each cycle is 28 days)). The study lists 4 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 4 Mar 2025.