CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Atezolizumab +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03853707
NCT03853707Phase 2Completed

A Phase I/IB Study of Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Patients With Metastatic Triple Negative Breast Cancer

City of Hope Medical Center·interventional·Posted Feb 26, 2019·Updated Feb 20, 2024

In Brief

A Phase 2 clinical trial evaluating Atezolizumab, Capecitabine, and 5 other interventions for Anatomic Stage IV Breast Cancer AJCC v8 and 2 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This phase I trial studies best dose of ipatasertib and how well it works with carboplatin with or without paclitaxel in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ipatasertib in combination with carboplatin, carboplatin/paclitaxel, or capecitabine/atezolizumab will work better in treating patients with triple negative breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 26, 2019
Enrollment StartMar 4, 2019
Primary CompletionJan 21, 2023
Study CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.4 years ago

Interventions

Atezolizumabdrug

Given IV

Capecitabinedrug

Given PO

Carboplatindrug

Given IV

Ipatasertibdrug

Given PO

Paclitaxeldrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies