Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline

Completed

Started Jan 2009

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.7 years study duration

Study Start

First participant enrolled

January 1, 2009

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed

Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

6.2 years

First QC Date

January 9, 2009

Last Update Submit

October 18, 2019

Conditions

Breast Cancer

Keywords

inflammatory breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancermale breast cancerHER2-negative breast cancer

Outcome Measures

Primary Outcomes (1)

Complete histologic response rate
Post surgery

Secondary Outcomes (6)

Progression-free survival
3 and 5 years
Overall survival
3 and 5 years
Toxicity as assessed by CTCAE v3.0
3 and 5 years
Predictive factors of response to bevacizumab
3 and 5 years
Circulating peripheral cells (circulating endothelial and tumor cells): correlation of initial rate and association with histological response after surgery
Post-surgery
+1 more secondary outcomes

Study Arms (1)

(FEC / Docetaxel) + Bevacizumab

EXPERIMENTAL

Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year

Biological: bevacizumabDrug: cyclophosphamideDrug: docetaxelDrug: epirubicin hydrochlorideDrug: fluorouracil

Interventions

bevacizumabBIOLOGICAL

During neoadjuvant phase: 15 mg/kg, d1 q3w, 8 cycles During adjuvant phase:15 mg/kg, d1 q3w, 10 cycles