Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood.
This research study involves the following investigational drugs:
* Sacituzumab govitecan * Atezolizumab
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed residual invasive breast cancer, in the breast and/or lymph node(s), following neoadjuvant chemotherapy. In the absence of residual invasive disease in the breast, lymph node must contain at least 2mm of invasive disease.
In situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), OR
Immunohistochemistry (IHC) 0 or IHC 1+.
NOTE: If more than one test result is available and not all results meet the inclusion criterion definition, all results should be discussed with the Principal Investigator to establish eligibility
Disqualifiers
Prior therapy with sacituzumab govitecan, irinotecan, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease.
Receipt of adjuvant chemotherapy (all chemotherapy prior to registration must have occurred in the preoperative setting)
Prior hypersensitivity to atezolizumab or the excipients of atezolizumab or sacituzumab govitecan
Clinical or radiographic evidence of metastatic disease
Trial design
Design model
Single group
Treatments tested in this trial
Atezolizumab
DrugAtezolizumab is a type of antibody and is administered intravenously.
Sacituzumab govitecan
DrugSacituzumab govitecan is an antibody drug conjugate and is administered intravenously
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Atezolizumab and Sacituzumab govitecanExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of undetectable circulating tumor cfDNA- 6 Cycles
Clearance of tumor cfDNA after 18 weeks, it will be tested using a one-sided one-sample binomial exact test (alpha 5%) against a null hypothesis value of 7% false negatives.
Time frame
18 WeeksSecondary outcomes
1
Rate of undetectable circulating tumor cfDNA - 1 Cycle
Proportion of patients with undetectable circulating tumor cfDNA after 1 cycle of combination therapy
Time frame
3 weeks2
Rate of undetectable circulating tumor cfDNA - 3 Cycles
Proportion of patients with undetectable circulating tumor cfDNA after 3 cycles of combination therapy
Time frame
9 weeks3
Number of Participants With Treatment-Related Adverse Events
Type, incidence and severity of adverse events (AEs) as graded by NCI CTCAE v5 criteria by 12 and 24 weeks.
Time frame
18 Weeks4
Invasive disease-free survival (iDFS) Rate
Estimated disease-free survival (iDFS) Rate with 90% CI
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov