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

NCT04464174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-07-26

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Antonio Llombart, MD · MedSIR

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2023-11-10
Completion
2023-11-10

Countries

  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04464174 on ClinicalTrials.gov