Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
- Conditions
- Breast Cancer MetastaticBreast Cancer Stage IV
- Interventions
- Registration Number
- NCT06680596
- Lead Sponsor
- UNICANCER
- Brief Summary
After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the efficacy of trastuzumab deruxtecan in terms of progression-free survival (PFS).
- Detailed Description
Eligible patients to the screening phase are patients with hormone receptor positive (estrogen receptor and/or progesterone receptor \>10%) and HER2 low or ultralow metastatic breast cancer who will receive standard first line therapy with CDK4-6i (any from the market), combined with aromatase inhibitor or fulvestrant. Patient persistence of tumor DNA in the blood at 4 weeks of this standard therapy will be included in the treatment phase with trastuzumab deruxtecan (T-DXd).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description T-DXd trastuzumab derxutecan T-DXd will be administrated as an intra-venous injection of 5.4 mg/kg every three weeks (1 cycle = 21-day treatment).
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From first treatment administration to disease progression or death, up to 5 years The progression-free survival is the length of time during and after treatment of the disease with T-DXd that a patient lives with the disease but it does not get worse.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) From the first T-DXd administration to death due to any cause, up to 5 years The overall survival is the length of time from first T-DXd administration that patients enrolled in the study are still alive.
Objective response Rate (ORR) From first T-DXd Administration to 6 months after the first administration of treatment, up to 5 years The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a T-DXd treatment.
Duration of response (DoR) From the date of first documentation to disease progression or death, up to 5 years The time from first documented response (CR or PR) until the date of the first disease progression or death from any cause, whichever occurs first.
Clinical benefit rate (CBR) From first T-DXd Administration to 6 months after the first administration of treatment, up to 5 years The clinical benefit risk is defined as the proportion of patients with at least a confirmed CR, PR, or a stable disease for 6 months or more after the first administration of treatment.
Time to response (TTR) From the first T-DXd administration to objective response, up to 5 years The time to response is defined as the time from the first T-DXd administration to the first documentation of CR or PR.
Toxicity during the study Throughout study completion, up to 5 years The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Trial Locations
- Locations (1)
Gustave Roussy
🇫🇷Villejuif, France