Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• The recent pathology results showed HR-positive and HER2-negative.

• 18F-FES-PET/CT showed at least one ER-positive lesion.

• ECOG 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 AE 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.