A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/12/2019 |
Start Date: | September 30, 2014 |
End Date: | July 31, 2019 |
A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer
This multicenter, randomized, double-blind study will estimate the efficacy, safety and
tolerability of ipatasertib combined with paclitaxel compared with placebo combined with
paclitaxel in participants with inoperable locally advanced or metastatic triple-negative
breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and
in participants with phosphatase and tensin homolog (PTEN)-low tumors.
tolerability of ipatasertib combined with paclitaxel compared with placebo combined with
paclitaxel in participants with inoperable locally advanced or metastatic triple-negative
breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and
in participants with phosphatase and tensin homolog (PTEN)-low tumors.
Inclusion Criteria:
- Histologically documented triple-negative adenocarcinoma of the breast that is
inoperable locally advanced or metastatic and is not amenable to resection with
curative intent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor
specimen, required prior to randomization
- Measurable disease, according to the RECIST v1.1
- Adequate hematologic and organ function within 14 days before the first study
treatment
- For female participants of childbearing potential, agreement (by both participant and
partner) to use an effective form of contraception for the duration of the study and
for 6 months after last dose of study treatment
Exclusion Criteria:
- Any previous therapy, including chemotherapy or hormonal or targeted therapy, for
inoperable locally advanced or metastatic triple-negative adenocarcinoma of the
breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy
and/or radiation treatment for locally advanced triple negative adenocarcinoma,
provided all treatments were completed greater than or equal to (>/=) 6 months prior
to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with
curative intent
- Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
- Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor
(ER) positive, or progesterone receptor (PR) positive breast cancer
- Previous therapy with Akt, PI3K, and/or mTOR inhibitors
- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days
prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during
the course of the study
- Known presence of the brain or spinal cord metastasis, as determined by computed
tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or
prior radiographic assessments
We found this trial at
26
sites
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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1 Medical Center Drive
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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