NCT02623972

A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

A Phase 2 Study of Eribulin Followed by Doxorubicin and Cyclophosphamide as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a drug called eribulin combined with standard treatment as a possible preoperative treatment for HER2 negative inflammatory breast cancer.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. Eribulin works by interfering with cancer cell division, growth, and spread. The goal of this research study is to evaluate inflammatory breast cancer's response to treatment with eribulin followed by AC chemotherapy (Cohort A) and also the response to treatment with AC followed by Eribulin (Cohort B) when given as a preoperative chemotherapy treatment for participants with HER2 negative inflammatory breast cancer.

Conditions

• Inflammatory Breast Cancer
• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Interventions

Type	Name	Description
DRUG	Eribulin	administered IV for 4 cycles
DRUG	Adriamycin	administered IV with cyclophosphamide for 4 cycles
DRUG	Cyclophosphamide	administered IV with adriamycin for 4 cycles

Timeline

• Start date: 2016-02-26
• Primary completion: 2021-05-01
• Completion: 2026-12-01
• First posted: 2015-12-08
• Last updated: 2025-11-25
• Results posted: 2022-12-28

Locations

2 sites across 1 country: United States