HR+/HER2- Advanced Breast CancerNCT06711094
Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC
A study testing Dalpiciclib in people with HR+/HER2- Advanced Breast Cancer, run by Fujian Medical University.
Trial summary
This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR+/HER2- Advanced Breast Cancer
- What is being tested?
- Dalpiciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Dec 2028
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal or premenopausal/perimenopausal women ≥18 years old and ≤75 years old, meeting one of the following criteria: a) prior bilateral oophorectomy, or ≥60 years old; Or b) age <60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; Or c) premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRH agonist therapy during the study period.
- Female breast cancer patients diagnosed by pathology as ER-Low positive (1%-10%) and HER2-negative have evidence of focal recurrence or metastasis, and are not suitable for surgical resection or radiotherapy for the purpose of cure. a) Low ER expression was defined as: the proportion of tumor cells with positive staining accounted for ≥ 1% and ≤10% of all tumor cells (confirmed by investigators in the study center); b) HER2 negative is defined as a standard immunohistochemical (IHC) test of 0/1+; Or the IHC test is 2+ and the ISH test is negative (reviewed and confirmed by the investigator at the study center).
- Have not previously received any systemic anticancer therapy for recurrent or metastatic disease.
- The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0-1.
- Measurable lesions or bone metastases only (including osteolytic lesions or mixed osteolytic/osteoblastic lesions) that meet RECIST 1.1 criteria.
- Adequate organ and bone marrow function.
- Women of reproductive age must have a negative serum pregnancy test within 7 days prior to enrollment and be willing to use a medically approved highly effective contraceptive during the study period and within 3 months after the last study drug administration.
- Remission of all acute toxic reactions from previous antitumor therapy to grade 0-1 (according to NCICTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria. The exception is other toxicities, such as hair loss, that researchers believe do not pose a safety risk to patients.
Who cannot join
- Previous pathological examination diagnosed HER2-positive breast cancer.
- Inflammatory breast cancer.
- Disease progression or recurrence during prior adjuvant therapy or within 12 months after completion of adjuvant therapy.
- Patients judged unsuitable for chemotherapy by the investigators. This includes symptomatic, advanced patients who have spread to the viscera and are at risk of developing life-threatening complications in the short term (including patients with uncontrolled exudation [thoracic, pericardial, abdominal], pulmonary lymphangitis, and more than 50% liver involvement).
- Patients with symptomatic active brain metastases or meningeal metastases were confirmed by cranial CT or MRI.
- Previous treatment with any CDK4/6 inhibitors.
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- Major surgery, chemotherapy, radiation therapy, any investigational drug, or other anti-cancer treatment within 2 weeks prior to study entry.
- Any other malignant tumor diagnosed within 3 years prior to study entry, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ after radical treatment.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C.
- Within 6 months prior to entering the study, the following situations occurred: Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, persistent arrhythmias ≥ grade 2 (according to NCI CTCAE 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism).
- Severe infection within 4 weeks prior to the first dose (e.g. intravenous antibiotic, antifungal, or antiviral medication required according to clinical practice), or unexplained fever >38.5°C during screening/prior to the first dose.
- Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of medications.
- Known allergy to albumin-bound paclitaxel, letrozole, anastrozole, Metrotan, LHRH agonists (goserrelin, leprerelin), Darcilil, or any excipients.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of psychotropic substance abuse or drug use.
- The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participation in the study or interfere with the study results, as well as patients deemed unsuitable for participation in the study by the investigator.
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: Single-arm,Exploratory Clinical Study of Albumin-bound Paclitaxel Combination With Dalpiciclib and AI in the Treatment of ER-Low (1%-10%), HER2-negative Advanced Breast Cancer
This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.
Read the detailed description
This is a prospective, single-arm, single-center, open, exploratory clinical study. Simon two-stage sample size calculation was used in this study, and the primary endpoint was objective response rate (ORR). P0=37.3% (POLAMA-4 experimental group data), P1=53.2%, unilateral α=0.05, 1-β=80% were set. PASS15 software was used to calculate 21 cases in the first stage, with a total sample size of 52 cases. If 8 patients in Phase I achieve an objective response, proceed to Phase II. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative (IHC 0/1+ or IHC 2+ but ISH-) breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.
- Conditions
- HR+/HER2- Advanced Breast Cancer
- Being tested
- Dalpiciclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpiciclibDrug
Dalpiciclib: 125mg orally, with a treatment cycle every 28 days, with continuous administration for the first 3 weeks (days 1 to 21) and rest (no medication) for the second 1 week (days 22 to 28). It is recommended to take Dalpiciclib at about the same time every day.
Albumin-bound paclitaxel for injection: 125mg/m2, intravenous infusion for 30 minutes, D1, D8, every 28 days for a treatment cycle, at least ≥6 treatment courses.
Endocrine therapy: Endocrine therapy drugs are selected by the investigator
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | albumin-bound paclitaxel、Dalpiciclib and AI Receives: Drug: Dalpiciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To assess and compare objective response rate (ORR) using RECIST 1.1
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
PFS
To assess and compare efficacy by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors 1.1 [RECIST 1.1]
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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
- Model description
- prospective, single-arm, single-center, open, exploratory clinical study
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Wu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711094
- Sponsor's protocol ID
- Fujian Cancer Hospital
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm,Exploratory Clinical Study of Albumin-bound Paclitaxel Combination With Dalpiciclib and AI in the Treatment of ER-Low (1%-10%), HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06711094
- Acronym / sponsor ID
- Fujian Cancer Hospital
- Conditions
- HR+/HER2- Advanced Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Dec 2024 (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 is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.
Detailed description
This is a prospective, single-arm, single-center, open, exploratory clinical study. Simon two-stage sample size calculation was used in this study, and the primary endpoint was objective response rate (ORR). P0=37.3% (POLAMA-4 experimental group data), P1=53.2%, unilateral α=0.05, 1-β=80% were set. PASS15 software was used to calculate 21 cases in the first stage, with a total sample size of 52 cases. If 8 patients in Phase I achieve an objective response, proceed to Phase II. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative (IHC 0/1+ or IHC 2+ but ISH-) breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single-arm, single-center, open, exploratory clinical study
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: Dalpiciclibalbumin-bound paclitaxel、Dalpiciclib and AI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postmenopausal or premenopausal/perimenopausal women ≥18 years old and ≤75 years old, meeting one of the following criteria: a) prior bilateral oophorectomy, or ≥60 years old; Or b) age <60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; Or c) premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRH agonist therapy during the study period.
- Female breast cancer patients diagnosed by pathology as ER-Low positive (1%-10%) and HER2-negative have evidence of focal recurrence or metastasis, and are not suitable for surgical resection or radiotherapy for the purpose of cure. a) Low ER expression was defined as: the proportion of tumor cells with positive staining accounted for ≥ 1% and ≤10% of all tumor cells (confirmed by investigators in the study center); b) HER2 negative is defined as a standard immunohistochemical (IHC) test of 0/1+; Or the IHC test is 2+ and the ISH test is negative (reviewed and confirmed by the investigator at the study center).
- Have not previously received any systemic anticancer therapy for recurrent or metastatic disease.
- The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0-1.
- Measurable lesions or bone metastases only (including osteolytic lesions or mixed osteolytic/osteoblastic lesions) that meet RECIST 1.1 criteria.
Key exclusion criteria (16 listed)
- Previous pathological examination diagnosed HER2-positive breast cancer.
- Inflammatory breast cancer.
- Disease progression or recurrence during prior adjuvant therapy or within 12 months after completion of adjuvant therapy.
- Patients judged unsuitable for chemotherapy by the investigators. This includes symptomatic, advanced patients who have spread to the viscera and are at risk of developing life-threatening complications in the short term (including patients with uncontrolled exudation [thoracic, pericardial, abdominal], pulmonary lymphangitis, and more than 50% liver involvement).
- Patients with symptomatic active brain metastases or meningeal metastases were confirmed by cranial CT or MRI.
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 |
|---|---|---|
| DalpiciclibDalpiciclib: 125mg orally, with a treatment cycle every 28 days, with continuous administration for the first 3 weeks (days 1 to 21) and rest (no medication) for the second 1 week (days 22 to 28). It is recommended to take Dalpiciclib at about the same time every day. Albumin-bound paclitaxel for injection: 125mg/m2, intravenous infusion for 30 minutes, D1, D8, every 28 days for a treatment cycle, at least ≥6 treatment courses. Endocrine therapy: Endocrine therapy drugs are selected by the investigator | Drug | experimental |
Primary outcome
ORR
Time frame: through study completion, an average of 2 year
To assess and compare objective response rate (ORR) using RECIST 1.1
1 secondary outcome
PFS
Time frame: through study completion, an average of 2 year
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 2 Dec 2024.
- Individual participant dataSharing planned: No
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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 study testing Dalpiciclib in people with HR+/HER2- Advanced Breast Cancer, run by Fujian Medical University.
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 16 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 2 Dec 2024. 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.
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 Wu Fan, Ph.D (13859082118, alienglass@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: through study completion, an average of 2 year). 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 2 Dec 2024.