A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF ATEZOLIZUMAB PLUS CHEMOTHERAPY FOR PATIENTS WITH EARLY RELAPSING RECURRENT (INOPERABLE LOCALLY ADVANCED OR METASTATIC) TRIPLE-NEGATIVE BREAST CANCER
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-070-20
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
1. Have provided written informed consent
2. Male or female ≥ 18 years of age
3. In the investigator’s judgment is willing and able to comply with the study protocol including completion of patient-reported outcomes questionnaires
4. Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic.
5. Prior treatment (of early breast cancer) with an anthracycline and taxane
6. Documented disease progression (e.g., with biopsy sample, pathology, or imaging report) occurring within 12 months (<12 months) from the last treatment with curative intent, i.e.
7. Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence.
8.Measurable or non-measurable disease, as defined by RECIST 1.1 (Note: previously irradiated lesions may be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation).
9. 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.
1. 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.
2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
3. Symptomatic or rapid visceral progression
4. History of leptomeningeal disease
5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)
6. Uncontrolled tumour-related pain
7. Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionised calcium or total calcium > 3 mmol/L or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
8. 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:time from randomisation to death from any cause.<br>Measure:Overall survival (OS)<br>Timepoints:Throughout the study.<br>
- Secondary Outcome Measures
Name Time Method