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

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.

Eligibility

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.

Conditions3

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