A Study to Evaluate the Efficacy and Safety of GDC-9545 Compared with Physician's Choice of Endocrine Monotherapy in Patients with Previously Treated Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
- Conditions
- Estrogen receptor (ER)-positive, HER2 negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic settingMedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: PTClassification code 10083232Term: HER2 negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-001984-10-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
•Age >= 18 years of age
•For women: postmenopausal or premenopausal/perimenopausal status:
o Age >= 60 years
o Age < 60 years and >= 12 months of amenorrhea without an alternative medical cause plus follicle-stimulating hormone and plasma estradiol levels within postmenopausal range by local laboratory assessment, in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin releasing hormone agonist or antagonist
o Documented bilateral oophorectomy
o Premenopausal/perimenopausal willing to undergo and maintain treatment with approved LHRH-agonist therapy
•For men: willing to undergo and maintain treatment with approved LHRH-agonist therapy
•Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
•Disease progression after treatment with one or two lines of systemic therapy in the locally advanced or metastatic setting
•Documented ER-positive tumor according to American Society of Clinical Oncology/College of American Pathologists guidelines
•Documented HER2-negative tumor assessed locally
•Confirmed availability of the most recently collected and representative tumor tissue specimen suitable for biomarker testing with de-identified associated pathology report is required. Whenever possible, tumor tissue from a metastatic site of disease is preferred, but archival tumor tissue from the primary tumor is acceptable if it is the most recently collected or most suitable for testing
•Measurable disease as defined per Response Evaluation Criteria in Solid Tumors, Version 1, or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
•Eastern Cooperative Oncology Group Performance Status 0-1
•Life expectancy of > 6 months
•Adequate organ function
•INR (or PT) < 1.5 × upper limit of normal (ULN) and PTT (or aPTT) < 1.5 × ULN
•Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade <= 1
•For women of childbearing potential: agreement to remain abstinent or use non-hormonal contraceptive methods with a failure rate of < 1% per year during the treatment period, and for 9 days after the final dose of GDC-9545 or for the time period according to local prescribing guidelines. Women must refrain from donating eggs during this same period
•For men: agreement to remain abstinent or use a condom, and must refrain from donating sperm for 9 days after the final dose of GDC-9545 to avoid exposing the embryo. Men must refrain from donating sperm during this same period. For female partners of male patients, hormonal contraceptive methods supplemented by a barrier method are permitted
•For the assigned to the control arm, women or men must comply with local prescribing guidelines regarding contraception for the chosen endocrine monotherapy
•Willing and able to use an electronic device for PRO data collection
•Ability to comply with the study protocol, in the investigator's judgment
•For patients enrolled in an extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
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 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
•Prior treatment with a SERD, with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
•Treatment with any investigational therapy within 28 days prior to randomization
•Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization
•History of any other malignancy other than breast cancer within 5 years prior to screening
•Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
•Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
•Active cardiac disease or history of cardiac dysfunction
•Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse, or cirrhosis
•Known HIV infection
•Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery, including gastric resection, potentially affecting enteral absorption
•Serious infection requiring oral or IV antibiotics within, or other clinically significant infection, 14 days prior to randomization. Patients who fully recovered from serious and clinically significant infections within 14 days prior to randomization are eligible.
•Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
•Known allergy or hypersensitivity to any of the study drugs or any of their excipients
•For premenopausal/perimenopausal patients or male patients: known hypersensitivity to LHRH agonists
•Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 days after the final dose of GDC-9545, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of endocrine monotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method