Atezolizumab for Early HER2-positive breast cancer

Stratification factors

• PD-L1 status (central; IC0 vs IC1/2/3)

Inclusion criteria

• {"criterion_text":"- Histologically confirmed invasive breast carcinoma"}
• {"criterion_text":"- Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph node(s) at surgery after completion of neoadjuvant therapy. Positive nodal residual disease, with or without residual invasive disease in the breast, is mandatory in patients with cT1-3/N0-1/M0 disease at presentation."}
• {"criterion_text":"- Diagnosis of HER2-positive breast cancer with assessment of hormone receptor and programmed death ligand 1 status , as documented through central testing of a representative tumor tissue specimen"}
• {"criterion_text":"- Completion of preoperative systemic chemotherapy and HER2-directed treatment"}
• {"criterion_text":"- Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes"}
• {"criterion_text":"- An interval of no more than 12 weeks between the date of primary surgery and the date of randomization"}

Exclusion criteria

• {"criterion_text":"- Stage IV (metastatic) breast cancer"}
• {"criterion_text":"- Inadequate excision"}
• {"criterion_text":"- An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy"}
• {"criterion_text":"- Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons"}
• {"criterion_text":"- History of other malignancy within 5 years prior to screening"}
• {"criterion_text":"- Prior treatment with atezolizumab"}

Primary endpoints

• {"endpoint_text":"- 1. Invasive disease-free survival","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1. Invasive disease-free survival including second primary non breast invasive cancer","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. IDFS, in the PD-L1-positive and the PD-L1-negative population (defined as all randomized patients from the ITT population with a centrally assessed PD-L1-positive [i.e., PD-L1 status of IC1/2/3] or PD-L1-negative status [i.e.,PD-L1 status of IC0] at randomization as per corresponding stratification factors recorded in the IWRS).","definition_or_measurement_approach":"Defined as IDFS assessed in PD-L1-positive (IC1/2/3) and PD-L1-negative (IC0) populations as centrally assessed at randomization per stratification factors in the IWRS."}
• {"endpoint_text":"- 3. Disease-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4 . Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5 . Distant recurrence-free interval","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6. The proportion of patients in each arm with clinically meaningful deterioration in GHS/QoL physical, role, and cognitive function as measured by scales of the European Organisation for Research and Treatment of Cancer quality of life questionnaire for cancer (EORTC QLQ C30)","definition_or_measurement_approach":"Proportion with clinically meaningful deterioration in global health status/quality of life (GHS/QoL) physical, role and cognitive function measured using EORTC QLQ-C30 scales."}
• {"endpoint_text":"- 7. Mean absolute scores and mean change from baseline scores in GHS/QoL, physical, role, and cognitive function, as assessed using the EORTC QLQ C30","definition_or_measurement_approach":"Mean absolute scores and mean change from baseline in GHS/QoL and functional scales as assessed by EORTC QLQ-C30."}
• {"endpoint_text":"- 8. Incidence and severity of adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- 9. Maximum and minimum serum concentrations for atezolizumab and trastuzumab emtansine","definition_or_measurement_approach":""}
• {"endpoint_text":"- 10. Incidence of antidrug antibodies (ADAs) to atezolizumab and to trastuzumab emtansine at specified timepoints","definition_or_measurement_approach":""}

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Yprime LLC

Responsibilities

EDC Provider

Name

IQVIA Limited

Responsibilities

1

Name

Almac Clinical Technologies LLC

Responsibilities

3

Name

CellCarta

Responsibilities

4

Name

Labcorp Central Laboratory Services S.a.r.l.

Responsibilities

4

Third parties

• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"EDC Provider","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharma Start LLC","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}