A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-019-20
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Progression-free survival (PFS), defined as the time from randomization to the first<br>occurrence of disease progression or death from any cause (whichever occurs first),<br>as determined by the investigator according to RECIST v1.1<br>Measure:Progression-free survival (PFS)<br>Timepoints:Throughout the study.<br>
- Secondary Outcome Measures
Name Time Method