Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
Launched by FUJIAN CANCER HOSPITAL · Aug 1, 2025
Trial Information
Current as of August 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for women with early-stage breast cancer that is hormone receptor-positive and HER2-negative, which is a common type of breast cancer. The study is testing whether adding a medicine called dalpiciclib to the usual hormone therapy after surgery can help prevent the cancer from coming back. Participants will take dalpiciclib at one of two doses—either 125 mg daily for 2 years or 100 mg daily for 3 years—alongside their standard hormone treatment. The main goal is to see how well this combination works over three years in keeping the cancer from returning or spreading.
Women who might be eligible for this study are those aged 18 or older who have had surgery for this specific type of breast cancer at an early stage (stage II or III), whether or not they’ve had chemotherapy before. They need to be in generally good health, with normal heart and organ function, and not currently pregnant or breastfeeding. If accepted into the trial, participants will be closely monitored for side effects and their overall health while taking the study medication. This trial is not yet open for enrollment but aims to find safer and more effective ways to reduce the risk of breast cancer returning after initial treatment.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female breast cancer patients aged ≥ 18 years, who are postmenopausal or premenopausal/perimenopausal;
- • Histologically confirmed HR-positive, HER2-negative early-stage breast cancer (immunohistochemical detection shows ER ≥ 10% and/or PR ≥ 10%, HER2 0-1+ or HER2 ++ but negative and non-amplified by FISH or CISH detection);
- • Histologically confirmed invasive breast cancer with postoperative pathological stage II-III;
- • Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy are eligible for enrollment;
- • The maximum time from surgery to enrollment does not exceed 12 months;
- • Patients receiving radiotherapy must have recovered from acute radiation reactions, with a washout period of at least 14 days from the end of radiotherapy to enrollment;
- • Patients who received previous chemotherapy must have recovered from acute adverse reactions of chemotherapy (graded ≤ 1 according to \[CTCAE\]) before enrollment, except for alopecia or grade 2 peripheral neuropathy. There must be a washout period of at least 21 days from the last chemotherapy administration to enrollment;
- • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- • The main organ function levels must meet the following requirements: Blood routine: Neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 90×10⁹/L; Hemoglobin (Hb) ≥ 90 g/L;Blood biochemistry: Total bilirubin (TBIL) ≤ 2.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×ULN; Alkaline phosphatase ≤ 2.5×ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5×ULN;
- • 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 ms in females (QTcF calculation formula: QTcF = QT/(RR\^1/3));
- • Voluntarily participate in this study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.
- Exclusion Criteria:
- • Stage IV breast cancer, recurrent or metastatic breast cancer, or inflammatory breast cancer;
- • A history of any malignant tumor, or having received anti-tumor treatment or radiotherapy for any malignant tumor in the past, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;
- • Concurrent participation in other clinical trials;
- • Having received blood transfusion or treatment with colony-stimulating factors, etc. within 2 weeks before enrollment;
- • Known history of allergy to the components of the drugs in this protocol;
- • History of immunodeficiency, including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
- • A history of any heart disease, including: angina pectoris; arrhythmia requiring drug treatment or with clinical significance; myocardial infarction; heart failure; any other heart disease judged by the researcher as unsuitable for participating in this trial;
- • Pregnant or lactating female patients;
- • Any other conditions that the researcher deems make the subject unsuitable for participating in this study.
About Fujian Cancer Hospital
Fujian Cancer Hospital is a leading institution in oncology research and treatment, dedicated to advancing cancer care through innovative clinical trials and comprehensive patient support. Located in Fuzhou, China, the hospital is recognized for its commitment to integrating cutting-edge medical technology with evidence-based practices. With a multidisciplinary team of experts, Fujian Cancer Hospital actively engages in clinical research aimed at developing novel therapeutic approaches and improving patient outcomes in cancer treatment. Their focus on collaboration and excellence positions them as a key player in the global effort to enhance cancer care and contribute to the scientific understanding of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported