Clinical trial · Interventional
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
An Exploratory Study on Predicting the Efficacy of Dalpiciclib in Combination With Endocrine Therapy for HR-Positive and HER2-Negative Recurrent/Metastatic Breast Cancer Patients After CDK4/6 Inhibitor Treatment Failure Using 18F-FES PET/CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy selected by the physician | Drug | — | UNRESOLVED |
| The combination of Dalpiciclib with physician-selected endocrine therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- The combination of Dalpiciclib with physician-selected endocrine therapy
- interventionNames
- Drug: The combination of Dalpiciclib with physician-selected endocrine therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Chemotherapy selected by the physician
- interventionNames
- Drug: Chemotherapy selected by the physician
Primary outcomes (1)
- measure
- Investigator-assessed PFS
- timeFrame
- Up to approximately 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * The recent pathology results showed HR-positive and HER2-negative. * 18F-FES-PET/CT showed at least one ER-positive lesion. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2 points. * Expected survival time ≥ 3 months. * Previous antitumor therapy: (1) (neo)adjuvant treatment with Palbociclib or Abemaciclib or Ribociclib or relapse after adjuvant treatment with Palbociclib or Abemaciclib or Ribociclib; (2) receiving Palbociclib or Abemaciclib or Ribociclib-based treatment in the context of metastatic breast cancer or disease progression after treatment; (3) previously received ≤1 line of chemotherapy for recurrent or metastatic breast cancer; (4) previously received ≤3 lines of endocrine therapy for recurrent or metastatic breast cancer. * Willing to undergo 18F-FDG PET/CT standard imaging. * At least one measurable lesion outside the skull according to RECIST V1.1. * The function of important organs meets the requirements. * The subjects have recovered from any adverse event related to previous tumor treatment (≤ Grade 1) before the first administration of the investigational drug. Exclusion Criteria: * 18F-FES-PET/CT shows that all lesions are ER-negative. * Previously received treatment with Dalpiciclib. * MRI or lumbar puncture confirms leptomeningeal metastasis. * Imaging confirms central nervous system metastasis. * Participants with visceral crisis, rapid disease progression, and patients not suitable for endocrine therapy. * Participants with ascites, baseline pleural effusion with clinical symptoms, and pericardial effusion requiring drainage within the first 4 weeks of treatment. * Unable to swallow, intestinal obstruction, or other factors that affect drug administration and absorption. * Participants diagnosed with any other malignancy within the past 5 years, excluding non-melanoma skin cancer treated with curative intent. Basal cell or squamous cell skin cancer, or cervical intraepithelial neoplasia and papillary thyroid cancer. * Participants who have undergone major surgery or suffered a major injury within 4 weeks before starting treatment, or are expected to undergo major surgical treatment. * Known history of allergy to the components of this treatment regimen.
References
Publications (0)
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