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Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)

RecruitingPhase 2Ages 18 Years - anyAllDana-Farber Cancer Institute
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * HER2 negative in primary tumor pre-treatment by local pathology assessed according to current ASCO/CAP guidelines: * 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 * ER and PR negative in primary tumor pre-treatment defined as \< 10% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment. * Patients must have received neoadjuvant chemotherapy prior to breast surgery. * Patients must be within 4 months of completion of all locoregional therapy (either last surgery or last dose of radiation, whichever is later) . Definitive breast surgery must have been performed and includes lumpectomy or mastectomy with pathologically clear margins (i.e. no ink on tumor). For patients undergoing lumpectomy, this must be followed by whole breast irradiation. Definitive surgery also includes axillary surgery, either sentinel lymph node biopsy or axillary lymph node dissection at the discretion of the attending surgeon. * Evidence of ctDNA in blood sample collected after completion of all local and systemic neoadjuvant therapy (preoperative chemotherapy, surgery and radiation), confirmed by central testing. Detection of any tumor specific mutations (TSMs) within the sample will be considered positive for purposes of study eligibility. * Concurrent receipt of bone modifying agents (bisphosphonates or rank-ligand inhibitors)is allowed. * Prior treatment with an immune checkpoint inhibitor in the neoadjuvant setting is permitted. * ECOG Performance Status of 0 or 1 * Men and women, age ≥ 18 years * Adequate hematologic and organ function defined by the following: * ANC ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor support * WBC count ≥ 2.5 × 109/L (2500/μL) * Absolute Lymphocyte count ≥ 0.5 × 109/L (500/μL) * Platelet count ≥ 100 × 109/L (100,000/μL) * Hemoglobin ≥ 90 g/L (9.0 g/dL), with or without transfusion * AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 × institutional upper limit of normal (ULN). * Serum bilirubin ≤ 1.5 × institutional ULN with the following exception: * Patients with known Gilbert syndrome: serum bilirubin level ≤ 3 × institutional ULN * Serum creatinine \< 1.5 x institutional ULN * Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation * Serum albumin ≥ 25 g/L (2.5 g/dL) * For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 × institutional ULN * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen * Women of childbearing potential (pre-menopausal) must have a negative serum or urine pregnancy test within 7 days prior to start of therapy. A woman is defined as premenopausal if she is less than 12 months from last menstrual period with no identified cause other than menopause (medication induced amenorrhea is not acceptable). Pregnancy test is not required in women who are surgically sterile via bilateral salpingooophorectomy or hysterectomy. * Women of childbearing potential and men must agree to use adequate contraception for the duration of protocol treatment and for 6 months after last dose of atezolizumab and 6 months after last dose of sacituzumab govitecan, whichever is later. Hormonal contraceptives are not acceptable (see section 5.6). * Ability to understand and the willingness to sign a written informed consent document. Non-English speakers are eligible to participate but will be excluded from surveys/questionnaires unless the participant has a proxy available for translation. Exclusion Criteria: * 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 * Residual DCIS or LCIS alone without invasive cancer OR pT0N0i and pT0N1mic residual disease * Concurrent enrollment on another investigational therapy trial * Prior treatment-related toxicity must be resolved to ≤ Grade 1 prior to study enrollment with the exception of alopecia and peripheral neuropathy, prior to study enrollment. * Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. * Intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, active tuberculosis, serious liver disease such as cirrhosis, active bleeding diathesis, uncontrolled Type I or Type II diabetes mellitus, Grade ≥ 2 uncontrolled or untreated hypercholesterolemia, Hypertriglyceridemia or hypercalcemia * Cardiovascular disease including: congestive heart failure of New York Heart Association Class III or IV, myocardial infarction (\<6 months prior to enrollment) unstable angina pectoris, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease, in the
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What it tests

  • Atezolizumab
  • Sacituzumab govitecan
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Where

7 sites
University of California San Francisco
San Francisco, United States
University of Chicago Medical Center
Chicago, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, United States
University of Chicago Medical Center for Advanced Care Orland Park
Orland Park, United States
Dana-Farber Cancer Institute
Boston, United States
University of Pennsylvania-Abramson Cancer Center
Philadelphia, United States
Vanderbilt-Ingram Cancer Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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