Spots Global Cancer Trial Database for CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study

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Trial Identification

Brief Title: CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study

Official Title: A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer

Study ID: NCT00412412

Conditions

Breast Cancer

Interventions

CNF2024

CNF2024 + trastuzumab

Study Description

Brief Summary: The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to: * find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely * measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood * determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing

Detailed Description: A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast Cancer