Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Trial acronym
Impassion 030
Clinical summary
Summary
Eligible participants will be randomised to receive chemotherapy alone; OR in combination with atezolizumab (IV, 840 mg), every two weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose. For both Arms, chemotherapy will consist of paclitaxel (IV, 80mg/m^2) every week for 12 weeks, followed by dose-dense doxorubicin and cyclophosphamide or dose-dense epirubicin and cyclophosphamide, every 2 weeks for 4 doses.
Conditions
This trial is treating people with triple negative breast cancer (TNBC)
Eligibility
Inclusion
- Non-metastatic operable Stage II-III breast cancer
- Histologically documented TNBC (Triple Negative Breast Cancer)
- Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
- Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
- No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
- Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.
Exclusion
- Prior history of invasive breast cancer
- For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
- Previous therapy with anthracyclines or taxanes for any malignancy
- Cardiopulmonary dysfunction
- Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Urinary outflow obstruction
- Active tuberculosis
- 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 study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
- Prior allogeneic stem cell or solid organ transplant
- Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
Inclusion
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
Scientific Title
A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer
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