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New treatment option for Breast Cancer
Official title Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
ClinicalTrials.gov ID: NCT04434040
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as Tecentriq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed residual invasive breast cancer, in the breast and/or lymph node(s), following neoadjuvant chemotherapy. In the absence of...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed...
- Active (acute or chronic) autoimmune disease of any type except hypothyroidism on a thyroid-replacement hormone, celiac disease, or well-controlled psoriasis, eczema, lichen simplex chronicus or vitiligo.
- Impairment of gastrointestinal function or active gastrointestinal disease that may significantly alter the absorption of the study agents (e.g., ulcerative disease, uncontrolled nausea(\> grade 2), vomiting (\> grade...
- Congenital long QT syndrome or screening QT interval corrected through use of Fridericia's formula \>480 ms.
- Participants known to be positive for the human immunodeficiency virus (HIV), Hepatitis B antigen (HepBsAg), or Hepatitis C virus (HCV) RNA are ineligible.
- History of prior invasive breast cancer in either breast.
- Participants with history of prior malignancy other than breast cancer are eligible if they have been disease-free for at least 5 years prior to enrollment with the exception of patients with thyroid cancer that has...
- Treatment with strong strong UGT1A1 inhibitor or inducer within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug.
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine while on protocol treatment
- Known allergy or hypersensitivity to any of the study drugs or any of their excipients, including chimeric or humanized antibodies or fusion proteins and Chinese hamster ovary cell products or recombinant human...
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2...
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible. o...
- Pregnant women are excluded from this study because the effects of sacituzumab govitecan and atezolizumab on a developing fetus are unknown. Breastfeeding should be discontinued prior to entry onto the study and for one...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Chicago, Illinois, United States
- New Lenox, Illinois, United States
- Orland Park, Illinois, United States
- Boston, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Chicago, Illinois, United States; New Lenox, Illinois, United States; Orland Park, Illinois, United States; Boston, Massachusetts, United States; Philadelphia, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.