Spots Global Cancer Trial Database for A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.

Official Title: This Study is a Phase I/II Clinical Evaluation of a New Investigational Agent, Lutetium-177-DOTAGA-IAC (HurlutinTM Lu-177) to Treat Patients With Unresectable Angiogenic Breast Cancer.

Study ID: NCT04469127

Conditions

Breast Cancer Stage IV

Interventions

Lutetium-177-DOTAGA-IAC

Study Description

Brief Summary: This study is a Phase I/II clinical evaluation of a new investigational agent, Lutetium-177-DOTAGA-IAC (HurlutinTM Lu-177) to treat patients with unresectable angiogenic breast cancer who have previously been treated with at least one prior line of therapy.

Detailed Description: This is a prospective, Phase I/II multi-center, interventional open-label study in a total of up to 100 subjects with angiogenic breast cancer. Phase I is to assess the safety and adequacy of a dose of HurlutinTM Lu-177 for up to three cycles, at 4-week intervals. It will include a dose expansion cohort of up to 20 patients. Phase II is to demonstrate the safety, dose adequacy, anti-tumor activity and efficacy of tumor targeted therapy using Lutetium-177-DOTAGA-IAC , as a second- or third-line treatment to extend survival and improve the quality of life of patients with angiogenic breast cancer.