A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Triple-Negative Breast Cancer

In brief

This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

Key facts

Study ID: NCT04177108
Run by: Hoffmann-La Roche
People needed: 242
Starts: 2019-11-25
Expected to finish: 2023-02-28
Last updated by the study team: 2024-03-27

Who can join

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

You may qualify if…

Willingness and ability to complete all study-related assessments, including Participant-Reported Outcome (PRO) assessments, in the investigator's judgement.
Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
Life expectancy of at least 6 months.
Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
Appropriate candidate for paclitaxel monotherapy if tumor programmed death-ligand 1 (PD-L1) status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.
Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.

You may not qualify if…

Inability to comply with study and follow-up procedures.
History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
Severe infection within 4 weeks prior to initiation of study treatment (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) as well as those who have received treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment.
Known human immunodeficiency virus (HIV) infection (there must be a negative HIV test at screening).
Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
Current treatment with anti-viral therapy for hepatitis B virus (HBV).
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib or (/) placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction less than (<) 50 percent (%), or active ventricular arrhythmia requiring medication.
Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) greater than (>) 480 milliseconds (ms).
Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
History or presence of an abnormal ECG that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction).
Requirement for chronic corticosteroid therapy of > 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease.
Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications.
History of or known presence of spinal cord metastases, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments.
Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases.
Known germline breast cancer gene (BRCA)1/2 deleterious mutation, unless the participant is not an appropriate candidate for a poly adenosine diphosphate ribose polymerase (PARP)-inhibitor.
Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast.
Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
Participants who have received palliative radiotherapy to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects (e.g., to Grade 1 or resolved by enrolment).
Uncontrolled pleural effusion, pericardial effusion or ascites.
Uncontrolled tumor-related pain.
Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.

Where it is running

Highlands Oncology Group — Springdale, Arkansas, United States
UCLA — Los Angeles, California, United States
Kaiser Permanente-SCPMG; Oncology Research — San Diego, California, United States
Stanford Cancer Center — Stanford, California, United States
Kaiser Permanente - Franklin — Denver, Colorado, United States
Stamford Hospital; BCC, MOHR — Stamford, Connecticut, United States
Holy Cross Hospital — Fort Lauderdale, Florida, United States
Memorial Healthcare System - Memorial Regional Hospital — Hollywood, Florida, United States
Memorial Cancer Institute at Memorial West — Pembroke Pines, Florida, United States
Winship Cancer Institute — Atlanta, Georgia, United States
Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME — Savannah, Georgia, United States
Rush University — Chicago, Illinois, United States
Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States
Ochsner Health System — New Orleans, Louisiana, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Mercy Medical Center — Baltimore, Maryland, United States
Medstar Franklin Square Medical Center — Baltimore, Maryland, United States
St. Joseph Mercy Hospital; Cancer Care Center. — Ann Arbor, Michigan, United States
Henry Ford Health System — Detroit, Michigan, United States
Jackson Oncology Associates, PLLC — Jackson, Mississippi, United States
CHI Health Saint Francis; Oncology — Grand Island, Nebraska, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Hackensack Univ Med Ctr — Hackensack, New Jersey, United States
Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
USA Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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