AN OPEN-LABEL, PHASE IIIB, SINGLE ARM,MULTICENTER SAFETY STUDY OFATEZOLIZUMAB (TECENTRIQ) PLUS NABPACLITAXEL OR PACLITAXEL IN THETREATMENT OF UNRESECTABLE LOCALLYADVANCED OR METASTATIC TRIPLE-NEGATIVEBREAST CANCER
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-028-19
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients must meet the following criteria for study entry:
1. Have provided written informed consent.
2. Female or male ≥ 18 years of age.
3. Ability to comply with the study protocol, in the investigator’s judgment.
4. Patients with unresectable locally advanced or metastatic, histologically documented TNBC
(negative for HER2 and ER and PgR).
5. Patient with at least one specimen positive for PD-L1 status as determined by VENTANA
PD-L1 SP142 Assay.
6. No prior chemotherapy, experimental or targeted systemic therapy for unresectable locally
advanced or metastatic TNBC.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
8. Life expectancy ≥ 12 weeks.
9. Measurable disease, as defined by RECIST v1.1.
10. Adequate haematologic and end-organ function, defined by the following laboratory results
obtained within 14 days prior to the initiation of study treatment (Cycle 1, Day 1).
See protocol for more detail.
Patients who meet any of the following criteria will be excluded from study entry:
Cancer-Specific Exclusion Criteria:
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 the first dose of study treatment (Cycle 1, Day 1).
2. Leptomeningeal carcinomatosis or any symptomatic CNS metastases
3. Uncontrolled symptomatic pleural effusion, pericardial effusion, or ascites
4. Uncontrolled tumour-related pain
5. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or
corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of
bisphosphonate therapy.
6. Malignancies other than TNBC within 5 years prior to the first dose of study treatment (Cycle
1, Day 1), with the exception of those with a negligible risk of metastasis or death and
treated with expected curative outcome (such as adequately treated carcinoma in situ of the
cervix or basal or squamous cell skin cancer).
See protocol for more detail.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Primary Safety Endpoints:<br>Incidence of treatment-emergent Grade≥3 AEs<br>Incidence of treatment-emergent Grade≥2 imAEs .<br><br>Measure:To evaluate the safety of atezolizumab<br>when given in combination with nabpaclitaxel/ paclitaxel in patients with<br>unresectable locally advanced or<br>metastatic PD-L1-positive TNBC<br>who have not received prior<br>systemic cytotoxic therapy for locally<br>advanced or metastatic TNBC.<br>Timepoints:Throughout study.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Secondary Safety Endpoints:<br>Incidence of all treatment-emergent AEs<br>Incidence of treatment-emergent SAEs.<br>Measure:To further evaluate the safety of<br>atezolizumab when given in<br>combination with nab-paclitaxel/<br>paclitaxel in patients with<br>unresectable locally advanced or<br>metastatic PD-L1-positive TNBC<br>who have not received prior systemic cytotoxic therapy for locally<br>advanced or metastatic TNBC.<br>Timepoints:Throughout study.<br>