HER2-positive metastatic breast cancer MedDRA version: 21.0 Level: LLT Classification code 10025541 Term: Malignant breast neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must be =18 years of age - Pathologically documented breast cancer that: 1. is advanced or metastatic 2. is locally assessed and prospectively centrally confirmed as HER2-positive (IHC3+ or ISH+) 3. is documented by local testing as hormone receptor (HR)-positive or HR-negative disease in the metastatic setting - No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer or only 1 previous line of endocrine therapy in the metastatic setting. Participants who have received chemotherapy or HER2-targeted therapy in the neo-adjuvant or adjuvant setting are eligible if > 6 months from treatment to metastatic diagnosis. - Has protocol-defined adequate organ and bone marrow function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 134
Exclusion criteria
Exclusion criteria: - Ineligible for any of the agents on the study. - Any substance abuse or other medical conditions that, in the investigator's opinion, may interfere with subject's participation or study results - Patients with spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases or treated brain metastases that are no longer symptomatic may be included in the study. - Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening - Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will evaluate the efficacy of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, compared with the standard of care (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment.;Secondary Objective: To assess the safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab, and report that of the standard of care (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab), in participants with HER2-positive, first-line metastatic breast cancer.;Primary end point(s): Progression Free Survival (PFS) defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.;Timepoint(s) of evaluation of this end point: Until progression or death, assessed up to approximately 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. Until progression or death, assessed up to approximately 60 months 2. Until death, assessed up to approximately 104 months 3. Until progression, assessed up to approximately 60 months 4. Assessed up to approximately 104 months 5. Assessed up to approximately 60 months 6. Up to Cycle 6, approximately Week 18; each cycle is 21 days 7. Up to follow-up period, approximately 60 months 8. Assessed up to approximately 60 months;Secondary end point(s): 1. Progression Free Survival (PFS) defined as time from date of randomisation until the date of objective radiological disease progression according to Investigator using RECIST 1.1 or death by any cause. 2. Overall Survival (OS) defined as the time from randomisation until the date of death due to any cause. 3. Objective Response Rate (ORR) and Duration of Response (DoR) by BICR and Investigator assessment. ORR is defined as The percentage of participants who have a complete response (CR) or partial response (PR) using RECIST 1.1. DoR is defined as the time from date of first detection of objective response until the date of objective radiological disease progression using RECIST 1.1 or death in the absence of progression. 4. Time to second progression or death (PFS2) by Investigator assessment 5. Health related quality of life (HRQoL) using the European Organisation for Research and Treatment of Cancer (EORTC) 6. Serum concentration of trastuzumab deruxtecan and pertuzumab 7. Immunogenicity of trastuzumab deruxtecan, alone or with pertuzumab. 8. Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab | — |
Countries
Argentina, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactStudy information Center
AstraZeneca
Outcome results
None listed