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A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer

NCT03800836•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•General:
•Eastern Cooperative Oncology Group Performance Status of 0 or 1.
•Adequate hematologic and organ function.
•For Cohorts 1, 2 and 4: Life expectancy of at least 6 months.
•For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 28 days after the last dose of ipatasertib, 6 months after the last dose of paclitaxel, nab-paclitaxel, or doxorubicin, and 12 months after the last dose of cyclophosphamide, and 5 months after the last dose of atezolizumab, whichever occurs later along with refraining from donating sperm or eggs during this same period.
•Disease-specific:
•For Cohorts 1, 2 and 4: histologically documented TNBC that is locally advanced or metastatic and is not amenable to resection with curative intent.
•For Cohort 2: disease progression following one or two lines of systemic therapy for inoperable locally advanced or metastatic TNBC.
•For Cohorts 1, 2 and 4: measurable disease according to RECIST v1.1 criteria.
•For Cohort 2: Treated brain or spinal cord metastases are allowed if participants have stable disease and are not on steroid treatment.
+3 more criteria

Exclusion Criteria

•General:
•History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
•Active infection requiring antibiotics.
•History of or current evidence of HIV infection.
•Known clinically significant history of liver disease.
•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 (other than anticipated breast surgery for Cohort 3) during the course of the study.
•Pregnant or breastfeeding.
•New York Heart Association (NYHA) Class II, III, or IV heart failure; left ventricular ejection fraction \< 50%; or active ventricular arrhythmia requiring medication.
•Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
•Prior treatment with an Akt inhibitor.
+25 more criteria

Locations (18)

Pacific Shores Medical Group

Long Beach, California, United States

St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept

Darlinghurst, New South Wales, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Center

North Melbourne, Victoria, Australia

Institut de Cancerologie de l Ouest

Angers, France

Institut Bergonie

Bordeaux, France

Centre Georges Francois Leclerc

Dijon, France

Institut Curie

Paris, France

Gustave Roussy

Villejuif, France

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Key Dates

Start Date

February 13, 2018

Primary Completion Date

March 16, 2022

Completion Date

March 16, 2022

Last Updated

October 30, 2024

Enrollment

139

ACTUAL participants

Conditions

Breast Cancer

Interventions

Ipatasertib

DRUG

Paclitaxel

DRUG

Atezolizumab

DRUG

Nab-Paclitaxel

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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