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

NCT01658462 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-03-16

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jacques BONNETERRE, MD PhD · Oscar Lambret Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-12-31
Completion
2017-10-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01658462 on ClinicalTrials.gov