Advanced Breast CancerPhase 2NCT05469750
Dalpiciclib Plus Letrozole and Capecitabine
A Phase 2 study testing Dalpiciclib+ letrozole +capecitabine in people with Advanced Breast Cancer, run by Fujian Medical University Union Hospital.
Trial summary
to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Dalpiciclib+ letrozole +capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2022to Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age:18-75 years old, Postmenopausal or premenopausal/perimenopausal female;
- HR-positive, HER2-negative breast cancer diagnosed by pathology, patients have evidence of focal recurrence or metastasis, are not suitable for curative surgical resection or radiotherapy, and have no clinical indications for chemotherapy.
- ER positivity and/or PR positivity is defined as: the proportion of tumor cells with positive staining is ≥ 1% of all tumor cells (confirmed by the investigator of the trial center);
- HER2-negative is defined as: 0/1+ by standard immunohistochemistry (IHC); HER2/CEP17 ratio less than 2.0 or HER2 gene copy number less than 4 by ISH (confirmed by the investigator of the trial center).
- Patients must meet one of the following criteria:
- ≥2 organ metastases (internal organs)
Show all 24Show fewer
- Metastasis to a single organ (visceral organ) and meets at least one of the following criteria:
- At least 2 or more measurable lesions
- High histological/cytonuclear grade 3 as defined by the modified Bloom-Richardson grading system (also known as the Nottingham scale)
- Ki67>30%
- Simple bone metastases combined with ≥ 1 other recurrent metastatic site
- No received any prior systemic anticancer therapy for focal recurrent or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- The main organs function well, and the inspection indicators meet the following requirements:
- HB≥90g/L;
- ANC≥1.5×109/L;
- PLT≥100×109/L;
- ALT and AST≤3×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases；
- TBIL≤1.5×ULN；
- Serum creatinine ≤1.5×ULN;
- There are measurable lesions meeting RECIST 1.1 criteria.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and be willing to use a medically-approved high-efficiency contraceptive during the study period and within 3 months after the last dose of study drug.
- All acute toxicities of previous antitumor therapy were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified by the inclusion/exclusion criteria. Other toxicities, such as alopecia, were excluded due to that the researchers believe do not pose a safety risk to patients.
- Participants were willing to join in this study, and written informed consent.
Who cannot join
- Patients with isolated bone metastases and/or brain metastases;
- Diagnosed with any other malignant tumor within 3 years before entering the study, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer or cervical carcinoma in situ after radical treatment.
- Patients who were judged by the investigator to be unsuitable for endocrine therapy, including symptomatic, advanced patients with visceral dissemination who were at risk for short-term life-threatening complications (including uncontrolled massive exudates [thoracic, pericardial, abdominal], pulmonary lymphangitis, and more than 50% of patients with liver involvement)
- The patient had previously received pyrimidine analogs and any CDK4/6 inhibitor.
- Major surgery, chemotherapy, radiation therapy, any investigational drug, or other anticancer therapy within 2 weeks.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU/ml), hepatitis C (positive for hepatitis C antibody, and high HCV-RNA) the lower limit of detection of the analytical method) or co-infection with hepatitis B and C.
Show all 13Show fewer
- Within 6 months, the following conditions have occurred: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, sustained arrhythmia of ≥ class 2 (according to NCI CTCAE version 5.0), atrial arrhythmia of any class Fibrillation, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism);
- Complicated severe infection within 4 weeks before the first dose (eg: intravenous infusion of antibiotics, antifungal or antiviral drugs required according to clinical practice), or unexplained fever >38.5°C during screening/before the first dose.
- Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption.
- Known hypersensitivity to letrozole, an LHRH agonist (goserelin), dalpiciclib, or any excipients.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of psychotropic substance abuse or drug use.
- There are other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, and patients who are considered unsuitable for participation in this study by the investigator.
About this study
Official title: A Single Arm，Multicenter，Open-label Study of Dalpiciclib Plus Letrozole and Capecitabine of First-line Treatment With High-risk HR- Positive /HER-2 Negative Advanced Breast Cancer
to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with breast cancer
Read the detailed description
The purpose of the study is to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with high-risk for HR- positive /HER-2 negative advanced breast cancer
- Conditions
- Advanced Breast Cancer
- Being tested
- Dalpiciclib+ letrozole +capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalpiciclib+ letrozole +capecitabineDrug
Continue medication to disease progression
| Study group | Role | What they receive |
|---|---|---|
| Dalpiciclib+ letrozole +capecitabine | Experimental | Dalpiciclib 150 mg was given orally once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
letrozole 2.5mg po qd capecitabine 1000mg/m2 po bid Receives: Drug: Dalpiciclib+ letrozole +capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 24 month
Secondary outcomes (1)
CBR
Clinical Benefit Rate
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start10 Aug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469750
- Sponsor's protocol ID
- 2022YF035-01
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- 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 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm，Multicenter，Open-label Study of Dalpiciclib Plus Letrozole and Capecitabine of First-line Treatment With High-risk HR- Positive /HER-2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05469750
- Acronym / sponsor ID
- 2022YF035-01
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 10 Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 22 Jul 2022 (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.
to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with breast cancer
Detailed description
The purpose of the study is to assess the effect of dalpiciclib plus letrozole and capecitabine of first-line treatment with high-risk for HR- positive /HER-2 negative advanced breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalpiciclib+ letrozole +capecitabine | Experimental | Drug: Dalpiciclib+ letrozole +capecitabineDalpiciclib 150 mg was given orally once daily for 3 weeks, followed by 1 week off in each 4-week cycle. letrozole 2.5mg po qd capecitabine 1000mg/m2 po bid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age:18-75 years old, Postmenopausal or premenopausal/perimenopausal female;
- HR-positive, HER2-negative breast cancer diagnosed by pathology, patients have evidence of focal recurrence or metastasis, are not suitable for curative surgical resection or radiotherapy, and have no clinical indications for chemotherapy.
- Patients must meet one of the following criteria:
- No received any prior systemic anticancer therapy for focal recurrent or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (13 listed)
- Patients with isolated bone metastases and/or brain metastases;
- Diagnosed with any other malignant tumor within 3 years before entering the study, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer or cervical carcinoma in situ after radical treatment.
- Patients who were judged by the investigator to be unsuitable for endocrine therapy, including symptomatic, advanced patients with visceral dissemination who were at risk for short-term life-threatening complications (including uncontrolled massive exudates [thoracic, pericardial, abdominal], pulmonary lymphangitis, and more than 50% of patients with liver involvement)
- The patient had previously received pyrimidine analogs and any CDK4/6 inhibitor.
- Major surgery, chemotherapy, radiation therapy, any investigational drug, or other anticancer therapy within 2 weeks.
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 |
|---|---|---|
| Dalpiciclib+ letrozole +capecitabineContinue medication to disease progression | Drug | Dalpiciclib+ letrozole +capecitabine |
Primary outcome
ORR
Time frame: 24 month
Objective response rate
1 secondary outcome
CBR
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 3
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
Advanced Breast Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalpiciclib+ letrozole +capecitabine in people with Advanced Breast Cancer, run by Fujian Medical University Union Hospital.
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 24 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Jul 2022. 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 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?
Results are not available in the source record.
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?
ORR (time frame: 24 month). 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 22 Jul 2022.