Actively Recruiting
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
Led by Peking Union Medical College Hospital · Updated on 2024-03-12
80
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival. In this study, 18F-FES PET/CT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients.
CONDITIONS
Official Title
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recent pathology confirming HR-positive and HER2-negative breast cancer
- At least one ER-positive lesion shown by 18F-FES-PET/CT
- Eastern Cooperative Oncology Group (ECOG) Performance Status score between 0 and 2
- Expected survival time of 3 months or more
- Prior treatment with Palbociclib, Abemaciclib, or Ribociclib in adjuvant or metastatic settings
- Received one or fewer lines of chemotherapy for recurrent or metastatic breast cancer
- Received up to three lines of endocrine therapy for recurrent or metastatic breast cancer
- Willingness to undergo 18F-FDG PET/CT imaging
- At least one measurable lesion outside the skull per RECIST V1.1
- Adequate function of important organs
- Recovery from any prior treatment-related adverse events to Grade 1 or less before starting study treatment
You will not qualify if you...
- All lesions are ER-negative on 18F-FES-PET/CT
- Previous treatment with Dalpiciclib
- Presence of leptomeningeal metastasis confirmed by MRI or lumbar puncture
- Central nervous system metastasis detected by imaging
- Visceral crisis, rapid disease progression, or unsuitable for endocrine therapy
- Ascites, symptomatic pleural effusion, or pericardial effusion requiring drainage within first 4 weeks
- Difficulty swallowing, intestinal obstruction, or conditions affecting drug absorption
- Diagnosis of any other malignancy within the past 5 years except certain skin or thyroid cancers
- Major surgery or major injury within 4 weeks before starting treatment or planned major surgery
- Known allergy to components of the treatment regimen
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
B
Bo Pan, M.D.
CONTACT
Q
Qiang Sun, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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