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 (IMpassion030)

STATUS

Recruiting
End date

Aug 24, 2025
participants needed

2300
sponsor

Hoffmann-La Roche

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Updated on 14 October 2022

See if I qualify

paclitaxel

cancer

breast surgery

cyclophosphamide

breast cancer

doxorubicin

anthracyclines

programmed cell death 1 ligand 1

triple negative breast cancer

taxane

triple-negative breast cancer

epirubicin

mastectomy

atezolizumab

breast-conserving surgery

mammogram

formalin-fixed paraffin-embedded

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Details

Condition	Triple Negative Breast Cancer
Treatment	cyclophosphamide, Paclitaxel, Atezolizumab, Dose-dense Doxorubicin or dose-dense Epirubicin
Clinical Study Identifier	NCT03498716
Sponsor	Hoffmann-La Roche
Last Modified on	14 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Criteria
	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

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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 (IMpassion030)