C50 Cancer de mama
Conditions
Interventions
None listed
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: • Signed Informed Consent Form • Age = 18 years at time of signing Informed Consent Form • For women: postmenopausal or premenopausal status, defined as follows: Postmenopausal • Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast not amenable to treatment with curative intent • Documented ER-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Allison et al. 2020), assessed locally and defined as =1% of tumor cells stained positive based on the most recent tumor biopsy (or archived tumor sample) Patient must be considered appropriate for endocrine therapy. • Documented HER2-negative tumor assessed locally and defined as meeting one of the following sets of criteria: – HER2 immunohistochemistry (IHC) score of 0 or 1+ – HER2 IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating the absence of HER2 gene amplification – HER2/CEP17 ratio of < 2.0 based on the most recent tumor biopsy (or archived tumor sample) Availability of the most recently collected and representative tumor tissue specimen (i.e., archived formalin-fixed paraffin-embedded tissue block or 15 slides containing unstained, freshly cut, serial sections [preferred]), with associated pathology report, and whenever possible, from a metastatic site of disease For more details, check the protocol
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: •?Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an aromatase inhibitor (i.e., anastrozole, letrozole, or exemestane) •?Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any cyclin-dependent kinase 4/6 inhibitor Prior treatment with a selective estrogen receptor degrader (e.g., fulvestrant) •?Prior treatment with tamoxifen is permitted, provided the patient did not experience disease recurrence within the first 24 months of treatment with tamoxifen •?Treatment with any investigational therapy within 28 days prior to study treatment •?Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization Patients who received prior radiotherapy to =25% of bone marrow are not eligible, regardless of when radiotherapy was received. Patient must have recovered from any resulting acute toxicity (to Grade 1 or better) prior to randomization. Anticipation of need for a major surgical procedure during the course of the study is exclusionary. •?Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization •?History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I endometrial cancer For more details, check the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 NAME OF THE RESULT: Progression-free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 NAME OF THE RESULT: Progression-free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the study.;TTD in physical functioning (PF), defined as the time from randomization to the first documentation of a = 10-point decrease from baseline in the EORTC QLQ-C30 linearly transformed PF scale score. NAME OF THE RESULT: TTD in physical functioning (PF). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;Overall survival (OS), defined as the time from randomization to death from any cause, which will be determined based on follow-up of patient. NAME OF THE RESULT: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the study.;Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions = 4 weeks apart, as determined by the investigator according to RECIST v1.1 NAME OF THE RESULT: Objective response rate (ORR) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout the study. For more detail please review the protocol.;Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 NAME OF THE RESULT: Duration of response (DOR) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Throughout study.;Clinical benefit rate (CBR), defined as the pr | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Korea South, Mexico, Peru, Portugal, Russian Federation, Spain, Taiwan, Thailand, United Kindgdom, United States
Outcome results
None listed