Spots Global Cancer Trial Database for Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer
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Trial Identification
Brief Title: Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer
Official Title: 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
Study ID: NCT04464174
Conditions
Study Description
Brief 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Champalimaud Clinical Centre - Champalimaud Foundation, Lisboa, , Portugal
Instituto Português de Oncologia do Porto FG, EPE (IPO-Porto), Porto, , Portugal
Hospital Provincial de Castellón, Castellón De La Plana, Castellón, Spain
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Dexeus, Barcelona, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitari Arnau de Vilanova, Lleida, , Spain
Hospital Quiron San Camilo- Ruber Juan Bravo, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Arnau de Vilanova, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Antonio Llombart, MD
Affiliation: MedSIR
Role: PRINCIPAL_INVESTIGATOR
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