Nintedanib+Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Safety and Pharmacodynamics

Breast Cancer Clinical Trial

Official title: Nintedanib Plus Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Phase 0/1 Safety and Pharmacodynamics

Status Completed

Clinical Trial Summary

Open, multicenter phase I with gradual increase in dosage to evaluate the safety and tolerability of orally administered nintedanib plus letrozole orally (2.5 mg / day) for patients with breast cancer. Nintedanib is administered twice a day orally for 28 consecutive days (Days 1-28) in 4-week cycles.

Clinical Trial Description

Phase 0 / I:

At level 1 it includes three patients. If any patient suffers dose limiting toxicity (DLT), it proceeds to the increase in dose to the next level. If 2/3 patients experience DLT, he will close the increased dose and extended / investigate the previous dose level with 3 additional patients.

If the level 2, but less than 1/3 the minimum of 6 patients experience TLD is reached, the phase I be suspended because not expected another rise above Level 2.

Dose levels:

• Level 1: Nintedanib 150 mg twice daily + oral letrozole 2.5 mg / day orally, in a cycle of 28 days.

• Level 2: Nintedanib 200 mg twice daily via oral + letrozole 2.5 mg / day orally, in a cycle of 28 days.

• At least the first cycle will be administered during Phase I. A total of six four-week cycles were administered at the discretion of the investigator. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02619162
• Study type: Interventional
• Source: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Status: Completed
• Phase: Phase 1
• Start date: July 2015
• Completion date: June 2018