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Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy in Early-stage HR-positive/HER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study

NCT07101159•Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy. The primary endpoint is 3-year invasive disease-free survival (iDFS).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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));
+1 more criteria

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.

Key Dates

Start Date

September 1, 2025

Primary Completion Date

December 1, 2031

Completion Date

December 1, 2031

Last Updated

August 3, 2025

Enrollment

200

ESTIMATED participants

Conditions

Early Breast CancerAdjuvant TherapyHormone Receptor Positive / HER2-negative Breast Cancer

Interventions

Dalpiciclib

DRUG

Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

DRUG

Dalpiciclib

DRUG

Contacts

Chuangui Song

CONTACT

+86 13960709993 songchuangui@yahoo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

Inclusion Criteria

Exclusion Criteria

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