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 (VAROCE)

NCT01658462 Phase 2 COMPLETED

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

Details

Lead sponsor	Centre Oscar Lambret
Phase	Phase 2
Status	COMPLETED
Enrolment	51
Start date	2013-05
Completion	2017-10-30

Conditions

• Breast Cancer

Interventions

• Docetaxel
• Nintedanib
• Docetaxel: increase of the dose

Primary outcomes

• Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B) — baseline, every 9 weeks (or 3 cycles), up to 6 months
  6-months progression free disease

Countries

France