A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).

Key facts

Study ID

NCT03726879

Run by

Hoffmann-La Roche

People needed

454

Starts

2019-01-11

Expected to finish

2023-08-24

Last updated by the study team

2024-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of HER2-positive breast cancer, and hormonal and PD-L1 status, as documented through central testing of a representative tumor tissue specimen
• Primary breast tumor size of > 2 cm by any radiographic measurement
• Stage at presentation: T2-T4, N1-N3, M0 as determined by AJCC staging system, 8th edition
• Pathologic confirmation of nodal involvement with malignancy must be determined by fine needle aspiration or core-needle biopsy. Surgical excision of lymph nodes is not permitted.
• Patients with multifocal tumors are eligible provided at least one focus is sampled and centrally confirmed as HER2-positive.
• Patients with multicentric tumors are eligible provided all discrete lesions are sampled and centrally confirmed as HER2-positive.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Baseline LVEF >= 55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
• Adequate hematologic and end-organ function obtained within 14 days prior to initiation of study treatment
• For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
• For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

You may not qualify if…

• Prior history of invasive breast cancer
• Stage IV (metastatic) breast cancer
• Patients with synchronous bilateral invasive breast cancer
• Prior systemic therapy for treatment of breast cancer
• Previous therapy with anthracyclines or taxanes for any malignancy
• Ulcerating or inflammatory breast cancer
• Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
• Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy
• History of other malignancy within 5 years prior to screening, with the exception of those patients who have a negligible risk of metastasis or death
• Cardiopulmonary dysfunction
• Dyspnea at rest
• Active or history of autoimmune disease or immune deficiency
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab/placebo, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, or 7 months after the final dose of trastuzumab, pertuzumab, or trastuzumab emtansine whichever occurs last
• Exclusion Criteria Related to Trastuzumab Emtansine in the Adjuvant Setting:
• Patients who achieved pCR
• Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery
• Unable to complete surgery with curative intent after conclusion of neoadjuvant systemic therapy
• Patient discontinued treatment with trastuzumab because of toxicity during the neoadjuvant phase of the study
• Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, or sclerosis cholangitis
• Patients with Grade >=2 peripheral neuropathy
• Prior treatment with trastuzumab emtansine

Where it is running

• New York University Medical Center PRIME; NYU Langone Medical Center — New York, New York, United States
• Tennessee Oncology - Nashville — Nashville, Tennessee, United States
• Hospital Sao Rafael - HSR — Salvador, Estado de Bahia, Brazil
• Hospital Araujo Jorge; Departamento de Ginecologia E Mama — Goiânia, Goiás, Brazil
• Hospital Nossa Senhora da Conceicao — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Perola Byington — São Paulo, São Paulo, Brazil
• Tom Baker Cancer Centre-Calgary — Calgary, Alberta, Canada
• BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Hopital du Saint Sacrement — Québec, Quebec, Canada
• Masarykuv onkologicky ustav — Brno, Czechia
• Fakultni nemocnice Olomouc; Onkologicka klinika — Olomouc, Czechia
• Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum — Essen, Germany
• Praxis für Interdisziplinäre Onkologie und Hämatologie GbR — Freiburg im Breisgau, Germany
• Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem — Hamburg, Germany
• Sankt Elisabeth Krankenhaus; Gynaekology — Leipzig, Germany
• Rotkreuzklinikum München; Frauenklinik — München, Germany
• Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe — Münster, Germany
• St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik — Paderborn, Germany
• Universitätsfrauenklinik Ulm; Abteilung Gynäkologie — Ulm, Germany
• Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica — Naples, Campania, Italy
• Università degli Studi Federico II; Clinica di Oncologia Medica — Naples, Campania, Italy
• Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica — Aviano, Friuli Venezia Giulia, Italy
• HCA Midwest Division — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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