Advanced or Metastatic ER+/HER2- Breast Cancer MedDRA version: 18.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: GDC-0810
Product Code: 705-6118/F01-01
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: GDC-0810 (RO7056118)
Other descriptive name: RO7056118
C
Sponsors
Genentech, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Postmenopausal women with histologically or cytologically confirmed invasive, estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) (defined by local guidelines) metastatic or inoperable (not amenable to resection or other local therapy with curative intent), locally advanced breast cancer - Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines - Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer - Radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or MBC - Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or non-measurable, evaluable disease with at least one evaluable bone lesion by RECIST v1.1 based on radiologic scans within 28 days of Day 1 of Cycle 1 - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Adequate hematologic and end-organ 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 144 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - HER2 positive disease (immunohistochemistry [IHC] 3+ staining, fluorescence in situ hybridization [FISH] positive, and/or chromogenic in situ hybridization [CISH] positive) - Prior treatment with fulvestrant - Prior anti-cancer therapy within 2 weeks prior to Cycle 1 Day 1 - Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1 - Prior treatment with >1 cytotoxic chemotherapy regimens or >2 endocrine therapies for advanced or metastatic disease - Ongoing, acute treatment-related toxicity that has not resolved to Grade <=1 or been deemed stable by the investigator - Concurrent hormone replacement therapy - Known untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) - History of other malignancy within the previous 5 years - Inability or unwillingness to swallow pills or receive intramuscular injections - Clinically significant cardiac or pulmonary dysfunction - Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of the need for major surgery during the course of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of GDC-0810 compared with fulvestrant in the intent to treat (ITT) population as measured by progression free survival (PFS) • To evaluate the efficacy of GDC-0810 compared with fulvestrant in the estrogen receptor 1 (ESR1) mutant population as measured by PFS ;Secondary Objective: • To assess the clinical activity of GDC-0810 versus fulvestrant, as measured by objective response rate (ORR), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) • To evaluate the safety and tolerability of GDC-0810 compared with fulvestrant, focusing on the nature, frequency, and severity of serious and non-serious adverse events • To assess the pharmacokinetics of GDC-0810 in patients with advanced or metastatic breast cancer (MBC) resistant to aromatase inhibitor (AI) therapy ;Primary end point(s): PFS as determined by the investigator per RECIST v1.1;Timepoint(s) of evaluation of this end point: 26 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. OS 2. ORR (partial response [PR] plus complete response [CR]) as determined by the investigator per RECIST v1.1 3. DOR as determined by the investigator per RECIST v1.1 4. CBR 5. Incidence of adverse events and serious adverse events 6. Clinically significant changes in vital signs, physical findings, and clinical laboratory results 7. Apparent clearance, volume of distribution, absorption rate constant of GDC-0810 ;Timepoint(s) of evaluation of this end point: 1-6. 26 months 7. Predose and 3 hours postdose at Cycle 1 Day 1 and Cycle 3 Day 1 | — |
Countries
Germany, Korea, Republic of, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed