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
Peking Union Medical College Hospital
80 participants
May 15, 2023
INTERVENTIONAL
Conditions
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 Criteria9
- The recent pathology results showed HR-positive and HER2-negative.
- F-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 Criteria10
- F-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.
Interventions
* 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
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05861830