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Tests treatment safety and results for Breast Diseases
Official title Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
ClinicalTrials.gov ID: NCT07581834
What this study is testing
What is Dalpiciclib 125mg?
Dalpiciclib 125mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for breast diseases.
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
- This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal/perimenopausal.
- Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry...
- Patients with histologically confirmed invasive breast cancer at clinical/pathological stages II-III. Note: For stage IIA, N1 is required, or N0 with...
- Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.
- The time interval from surgery to enrollment must not exceed 12 months.
You likely can't join if
- Stage IV breast cancer or recurrent/metastatic breast cancer, or inflammatory breast cancer;
- A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of...
- Participating in other clinical trials simultaneously;
- Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;
- Individuals with a known history of allergy to any component of this medication;
- A history of immunodeficiency, including a positive HIV test result, or other acquired or congenital immunodeficiency diseases, or a history of organ...
See the full eligibility criteria
- Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal/perimenopausal.
- Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry showing ER ≥10% and/or PR ≥10%, HER2 0-1+ or HER2 ++ but negative by FISH...
- Patients with histologically confirmed invasive breast cancer at clinical/pathological stages II-III. Note: For stage IIA, N1 is required, or N0 with Grade 3 or Grade 2 tumors combined with high-risk factors such as...
- Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.
- The time interval from surgery to enrollment must not exceed 12 months.
- Patients who have received radiotherapy must have recovered from the acute effects of radiotherapy, and there must be at least 14 days of washout period from the end of radiotherapy to enrollment.
- Patients who have previously received chemotherapy must have recovered from the acute adverse effects of chemotherapy before enrollment ([CTCAE] grade ≤1), except for hair loss or grade 2 peripheral neuropathy.There...
- Stage IV breast cancer or recurrent/metastatic breast cancer, or inflammatory breast cancer;
- A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous...
- Participating in other clinical trials simultaneously;
- Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;
- Individuals with a known history of allergy to any component of this medication;
- A history of immunodeficiency, including a positive HIV test result, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Any history of heart disease, including: (1) angina pectoris; (2) arrhythmias that require medical treatment or are clinically significant; (3) myocardial infarction; (4) heart failure; (5) any other heart disease...
- Pregnant or lactating female patients; 9. Any other circumstances in which the researchers deem the participant unsuitable for participating in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Chengdu, Sichuan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Chengdu, Sichuan, 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.