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RECRUITING

NCT05861830

PHASE3

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-05-15

Completion Date

2026-06-30

Last Updated

2024-03-12

Healthy Volunteers

Conditions

Advanced Breast Cancer

Interventions

DRUG

The combination of Dalpiciclib with physician-selected endocrine therapy

* Dalpiciclib: 150 mg, orally, once daily, on days 1-21, every 28 days (3 weeks on, 1 week off) * Letrozole: 2.5 mg, orally, once daily (continuous), every 28 days OR Anastrozole: 1.0 mg, orally, once daily (continuous), every 28 days OR Exemestane: 25 mg, orally, once daily (continuous), every 28 days OR Fulvestrant: 500 mg, intramuscular injection on day 1/15 of the first cycle, then on day 1 of each subsequent cycle, every 28 days OR Tamoxifen: 10-20 mg, orally, twice daily (continuous), every 28 days * Pre/perimenopausal women also require ovarian function suppression (OFS), which can be achieved through bilateral oophorectomy or the use of gonadotropin-releasing hormone (GnRH) analog drugs

DRUG

Chemotherapy selected by the physician

The chemotherapy regimen is chosen by the clinical physician and may include, but is not limited to, the following options: the combination of paclitaxel and capecitabine, the combination of paclitaxel and carboplatin, single-agent capecitabine, single-agent platinum drugs, and the combination of gemcitabine and platinum-based chemotherapy. Each treatment cycle consists of a 21-day duration.

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China