A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients with Early Relapsing Recurrent Triple-Negative Breast Cancer
- Conditions
- Triple-Negative Breast Cancer (TNBC)MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-005119-42-HU
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
- Male or female >= 18 years of age
- Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
- Prior treatment with an anthracycline and taxane
- Documented disease progression occurring within 12 months (<12 months) from the last treatment with curative intent
- Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence
- Measurable or non-measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumour block (preferred) or at least 17 unstained slides, collected within 3 months prior to randomisation with an associated pathology report, if available If a tumour sample taken within 3 months before randomisation is not available and a tumour biopsy is not clinically feasible, the primary surgical resection sample or the most recent FFPE tumour biopsy sample may be used. Of these additional options, the most recent sample should be used
- Eastern Cooperative Oncology Group performance status 0-1
- Life expectancy >= 12 weeks
- Adequate haematologic and end-organ function, Negative human immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- The HCV RNA test will be performed only for patients who have a positive HCV antibody test
- Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <=1% per year during the treatment period and for at least 5 months after the last dose of study treatment. In addition, women must refrain from donating eggs during the same time period
- Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of carboplatin/gemcitabine to avoid exposing the embryo.
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 292
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Symptomatic or rapid visceral progression
- History of leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled tumour-related pain
- Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Malignancies other than TNBC within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer)
- Significant cardiovascular disease
- Presence of an abnormal ECG that is clinically significant in the investigator’s opinion
- Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia
- Current treatment with anti-viral therapy for HBV
- Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
- Treatment with investigational therapy within 28 days prior to randomisation
- Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of study treatment
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