NCT04464174

Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer

A Multicenter, Open-Label, Non-Comparative, Three-Arm, Phase IIa Trial of Ipatasertib (GDC-0068) in Combination With Non-Taxane Chemotherapy Agents for Taxane-Pretreated Unresectable Locally Advanced or Metastatic TNBC Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, non-comparative, three-arm, phase IIa trial of Ipatasertib (GDC-0068) in combination with non-taxane chemotherapy agents for taxane-pretreated unresectable locally advanced or metastatic triple-negative breast cancer patients

Detailed description

Women age ≥ 18 years with triple-negative unresectable locally advanced or MBC that is not amenable to resection with curative intent. Patients must have received at least one, but not more than two, prior chemotherapeutic regimens for treatment of unresectable locally advanced and/or metastatic disease (at least one regimen must have contained a taxane). The number of patients to be included is 54 patients. The primary objective is to evaluate the safety and tolerability of ipatasertib (GDC-0068) in combination with capecitabine, eribulin, or carboplatin plus gemcitabine in patients with unresectable locally advanced or metastatic triple-negative breast cancer

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Ipatasertib	Ipatasertib administered orally (400 mg) once a day, from day 1 to day 14, and rest from day 15 to day 21 of every 21-day cycle
DRUG	Capecitabine	Capecitabine administered orally (1000 mg/m2) twice a day, from day 1 to day 14, and rest from day 15 to day 21 of every 21-day cycle
DRUG	Eribulin	Eribulin 1.23 mg/m2 administered intravenously Days 1 and 8 of every 21-day cycle
DRUG	Carboplatin	Carboplatin AUC5 administered intravenously day 1 of every 21-day cycle
DRUG	Gemcitabine	Gemcitabine administered intravenously (1000 mg/m2) at days 1 and 8 of every 21-day cycle

Timeline

• Start date: 2020-10-08
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2020-07-09
• Last updated: 2024-07-26

Locations

14 sites across 2 countries: Portugal, Spain