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Trial Title:
Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer
NCT ID:
NCT05512780
Condition:
Solid Tumor
Conditions: Official terms:
Letrozole
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
An exploratory study of a single-arm, open design
All subjects enrolled will receive the following treatment:
Dalpiciclib combined with Letrozole, 28 days as one cycle.
Arm group label:
Dalpiciclib+ letrozole
Other name:
Letrozole
Summary:
This is a single-arm, open-label, exploratory clinical study
Detailed description:
This is a single-arm, open-label, exploratory clinical study initiated by the
investigator to evaluate the objective response rate (ORR), efficacy, and safety of
Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2-
breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Postmenopausal women aged ≥18 years, the definition of postmenopausal:
1. the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or
2. Age <60, natural postmenopausal state (defined as the spontaneous cessation of
regular menstruation for at least 12 consecutive months, without other
pathological or physiological causes), E2 and FSH at the postmenopausal levels
2. All patients were estrogen receptor (ER) positive (>10%), HER2 -negative
invasive breast cancer regardless of PR expression level. Immunohistochemistry
(IHC) score of 0+, or 2+ confirmed by pathology laboratory and negative in situ
hybridization (ISH) test (HER-2/CEP17 ratio <2.0); 3. Treatment-naive patients
with stage Ⅱ-Ⅲ tumors whose tumor staging meets the criteria of the 8th edition
of the American Joint Committee on Cancer (AJCC) Staging;
Exclusion Criteria:
-
1. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular
targeted therapy, endocrine therapy, etc.) 2. Concurrently receiving any other
anti-tumor therapy that those specified in the protocol; 3. Bilateral breast
cancer, inflammatory breast cancer, or occult breast cancer; 4. Stage Ⅳ breast
cancer;
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 10, 2022
Completion date:
August 10, 2024
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512780