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Trial Title:
Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)
NCT ID:
NCT05640778
Condition:
Luminal B/HER2-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Aromatase Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib combined with aromatase inhibitors
Description:
Dalpiciclib combined with letrozole or anastrozole
Arm group label:
neoadjuvant endocrine therapy
Summary:
Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a
neoadjuvant therapy in Luminal B/HER2-negative breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient is ≥ 18 years-old at the time of consent to participate this trial
- Famale stage I-III breast cancer patients
- HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or
PgR<20%
- No prior anti-cancer treatment
- ECOG 0-1
Exclusion Criteria:
- Known to have other aggressive malignant tumor in the past 5 years.
- Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant
metastasis confirmed by pathology.
- There are other concomitant diseases that seriously threaten the patient's safety or
affect the patient's completion of the study, such as serious infection, liver
disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled
diabetes or dyslipidemia.
- Female patients during pregnancy or lactation.
- The investigator determines that subjects are not appropriate to participate in the
study due to other factors.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiding Chen
Investigator:
Last name:
Yiding Chen
Email:
Principal Investigator
Start date:
October 1, 2022
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
GeneCast Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640778
