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Tests treatment safety and results for Early Breast Cancer
Official title Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
ClinicalTrials.gov ID: NCT06341894
What this study is testing
What is Dalpiciclib?
Dalpiciclib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for early breast cancer.
Also referred to as CDK4/6 inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Patient is ≥ 18 years-old
- Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
- Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
- Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
- Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
You likely can't join if
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of...
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart...
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom.
See the full eligibility criteria
- Patient is ≥ 18 years-old
- Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
- Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
- Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
- Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
- From operation to enrollment should not exceed 12 months
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension...
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.