Back to resultsNeoadjuvant Dalpiciclib Plus Aromatase Inhibitors or Chemotherapy in Luminal B/HER2-negative Breast Cancer (DAPATH)
Primary Purpose
Luminal B/HER2-negative Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dalpiciclib combined with aromatase inhibitors
anthracycline-cyclophosphamide followed by taxane
Sponsored by
About this trial
This is an interventional treatment trial for Luminal B/HER2-negative Breast Cancer
Eligibility Criteria
Inclusion Criteria: Patient is ≥ 18 years-old at the time of consent to participate this trial Famale stage I-IIIA breast cancer patients or T4bN0-2M0 HR-positive, HER2-negtive invasive breast cancer, Ki67≥20% 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.
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
neoadjuvant endocrine therapy
neoadjuvant chemotherapy
Arm Description
CDK4/6 inhibitor combined with aromatase inhibitor
anthracycline-cyclophosphamide followed by taxane
Outcomes
Primary Outcome Measures
residual cancer burden
Secondary Outcome Measures
Full Information
NCT ID
NCT05640778
First Posted
November 30, 2022
Last Updated
February 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
GeneCast Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05640778
Brief Title
Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors or Chemotherapy in Luminal B/HER2-negative Breast Cancer (DAPATH)
Official Title
Comparison of Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy and Neoadjuvant Chemotherapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
GeneCast Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Compare the efficacy and safety of Dalpiciclib combined with aromatase inhibitors versus chemotherapy as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer, and explore the predictive biomarkers of the response to the two neoadjuvant therapies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Luminal B/HER2-negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neoadjuvant endocrine therapy
Arm Type
Experimental
Arm Description
CDK4/6 inhibitor combined with aromatase inhibitor
Arm Title
neoadjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
anthracycline-cyclophosphamide followed by taxane
Intervention Type
Drug
Intervention Name(s)
Dalpiciclib combined with aromatase inhibitors
Intervention Description
Dalpiciclib combined with letrozole or anastrozole
Intervention Type
Drug
Intervention Name(s)
anthracycline-cyclophosphamide followed by taxane
Intervention Description
4 cycles of anthracycline-cyclophosphamide (EC) followed by 4 cycles of taxane
Primary Outcome Measure Information:
Title
residual cancer burden
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is ≥ 18 years-old at the time of consent to participate this trial
Famale stage I-IIIA breast cancer patients or T4bN0-2M0
HR-positive, HER2-negtive invasive breast cancer, Ki67≥20% 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunxiang Zhou
Phone
+8615868131018
Email
yxzhou@zju.edu.cn
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiding Chen
First Name & Middle Initial & Last Name & Degree
Yiding Chen
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors or Chemotherapy in Luminal B/HER2-negative Breast Cancer (DAPATH)
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