Study Summary
This trial is studying whether a combination of the standard chemotherapy regimen for breast cancer plus the experimental drug atezolizumab is more effective than the standard chemotherapy regimen plus a placebo.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
Day 21
Cardiac safety lead-in (Troponin-T)
At time of surgical resection
Pathologic complete response in the breast (ypT0/Tis)
Pathologic complete response in the breast and lymph nodes (ypT0 ypN0)
Following completion of neoadjuvant therapy (ypT0/Tis ypN0)
Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
Week 6
Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)
Day 90
Frequency of Adverse Events
Frequency of immune Adverse Events of Special Interest
Week 24
Positive nodal status conversion rate
Year 5
Brain metastases free survival
Distant disease-free survival (DDFS)
Overall survival (OS)
Recurrence-free interval (RFI)
Year 5
Event-free survival (EFS)
From the first breast surgical procedure to the first disease recurrence or death from any cause
Disease-free survival (DFS)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Atezolizumab
27%Fatigue
25%Decreased appetite
24%Cough
19%Asthenia
19%Dyspnoea
18%Constipation
18%Nausea
18%Pyrexia
16%Diarrhoea
13%Arthralgia
12%Vomiting
12%Anaemia
11%Rash
11%Back pain
11%Musculoskeletal pain
10%Headache
9%Oedema peripheral
9%Weight decreased
9%Insomnia
9%Chest pain
9%Pruritus
9%Pain in extremity
8%Dizziness
7%Aspartate aminotransferase increased
7%Haemoptysis
7%Upper respiratory tract infection
7%Myalgia
6%Influenza like illness
6%Alanine aminotransferase increased
6%Bronchitis
6%Nasopharyngitis
6%Productive cough
5%Dry skin
5%Depression
5%Musculoskeletal chest pain
4%Urinary tract infection
4%Paraesthesia
4%Neuropathy peripheral
4%Abdominal pain
3%Stomatitis
3%Pneumonia
3%Dysgeusia
2%Pleural effusion
2%Malaise
2%Neutropenia
1%Respiratory tract infection
1%Pulmonary embolism
1%Peripheral sensory neuropathy
1%Sepsis
1%Pneumonitis
1%Alopecia
1%Mucosal inflammation
1%Bone pain
1%Lacrimation increased
Trial Design
2 Treatment Groups
Atezolizumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
1550 Total Participants · 2 Treatment Groups
Primary Treatment: Atezolizumab · Has Placebo Group · Phase 3
Atezolizumab
Drug
Experimental Group · 1 Intervention: Atezolizumab · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
Who is running the clinical trial?
NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
135,452 Total Patients Enrolled
45 Trials studying Breast Cancer
100,544 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,497 Previous Clinical Trials
563,109 Total Patients Enrolled
97 Trials studying Breast Cancer
23,271 Patients Enrolled for Breast Cancer
Hoffmann-La RocheIndustry Sponsor
2,360 Previous Clinical Trials
1,066,091 Total Patients Enrolled
155 Trials studying Breast Cancer
90,276 Patients Enrolled for Breast Cancer
Norman Wolmark, MDPrincipal InvestigatorNSBP Foundation, Inc.
58 Previous Clinical Trials
80,881 Total Patients Enrolled
30 Trials studying Breast Cancer
68,879 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The ECOG performance status must be good or excellent.
The patient must agree to participate and, before starting any study-specific procedures, must sign and date an IRB-approved consent form that follows FDA and institutional guidelines for study treatment and for submitting tumor samples for research purposes, as required by the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-59/GERPAR-DOUZE study on baseline correlative science studies.
The diagnosis of cancerous cells in the breast must have been made by taking a sample of the cells with a needle.
The tumor is negative for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 by the current guidelines from the American Society of Clinical Oncology and the College of American Pathologists.
The tumor must be determined to be estrogen receptor-negative, progesterone receptor-negative, and HER2-negative by current ASCO/CAP Guidelines recommendations.
The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 testing result
Patients must be at least 18 years old.
The patient may be female or male.
The tumor can be classified as stage T2 or T3 if it is node-negative according to the AJCC 7th Edition, but if the regional lymph nodes are cN1 and cytologically or histologically positive, or cN2-N3 with or without a biopsy, the tumor can be classified as stage T1c, T2, or T3.
Who else is applying?
What state do they live in?
| Pennsylvania | 50.0% |
| California | 50.0% |
How old are they?
| < 18 | 50.0% |
| 65+ | 50.0% |
What site did they apply to?
| Kaiser Permanente-Anaheim | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
References
- Pérez-García, José, Jesús Soberino, Fabricio Racca, María Gion, Agostina Stradella, and Javier Cortés. 2020. “Atezolizumab in the Treatment of Metastatic Triple-negative Breast Cancer”. Expert Opinion on Biological Therapy. Informa UK Limited. doi:10.1080/14712598.2020.1769063.
- Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
- 2017. "Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03281954.
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Treatments