NCT01658462

Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer

A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB (BIBF-1120) in Patient Receiving a First or Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer.

Detailed description

Patients will be stratified at randomization according to first-line chemotherapy / Second-line chemotherapy for metastatic or locally recurrent breast cancer Treatment until progression or unacceptable toxicity Visits are planned every 3 weeks during treatment and every 3 months after end of treatment or patient's withdrawal

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	75 mg/m2 IV Day 1 / 3 weeks
DRUG	Nintedanib	200 mg x 2 per os daily from D2\* \*No Nintedanib on days when docetaxel is administered
DRUG	Docetaxel: increase of the dose	Dose can be increased to 100 mg/m² secondarily at cycle 2 on the initiative of the investigator

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-12-31
• Completion: 2017-10-30
• First posted: 2012-08-07
• Last updated: 2026-03-16

Locations

12 sites across 1 country: France