Actively Recruiting
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-04-02
1163
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of dalpiciclib combined with endocrine therapy as an additional treatment for patients with medium to high risk hormone receptor-positive, HER2-negative early breast cancer. This phase II, multi-center, open-label trial focuses on this specific group of breast cancer patients to better understand treatment outcomes and safety profiles. Participants will receive dalpiciclib, a CDK4/6 inhibitor taken orally at 100 mg daily, alongside endocrine therapy using fulvestrant or aromatase inhibitors. This treatment is given as an adjuvant therapy, meaning it is administered following surgery to reduce the risk of cancer returning. The study includes only one treatment group combining these therapies. During the trial, participants will be monitored for invasive disease-free survival over a period of up to three years after enrollment. Researchers will also observe disease-free survival and record any adverse events or serious adverse events from the start of treatment until one month after the last dose. Participants will undergo regular assessments to evaluate their health status and treatment effects throughout the study.
CONDITIONS
Brief Title
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older
- Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
- Patient has histologically confirmed hormone receptor-positive, HER2-negative early breast cancer with ER and/or PR at least 10%
- Patient has invasive breast cancer with anatomic stages IIA to IIIC (T2-4N0-3M0), including stage IIA with T1N1M0
- Patient may have received neoadjuvant or adjuvant chemotherapy or radiotherapy
- Time from operation to enrollment must not exceed 12 months
- Patient has an ECOG Performance Status of 0 or 1
You will not qualify if you...
- Presence of metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current malignant cancers except for treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- Clinically relevant cardiovascular disease such as uncontrolled or symptomatic angina, significant arrhythmias, congestive heart failure, transmural myocardial infarction, or uncontrolled hypertension (≥180/110)
- History of allergy to the study drugs
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive dalpiciclib and endocrine therapy as adjuvant treatment for hormone receptor-positive, HER2-negative early breast cancer.
Regular visits during treatment period
Duration - Up to 1 month
Participants are monitored for safety and disease outcomes for up to one month after the last drug administration.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
X
Xiaoan Liu, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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