Spots Global Cancer Trial Database for Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer

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Trial Identification

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

Official Title: 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

Study ID: NCT01658462

Conditions

Breast Cancer

Interventions

Docetaxel

Nintedanib

Docetaxel: increase of the dose

Study Description

Brief 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