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

NCT01658462 | Completed Phase 2 DMC

• 2 other identifiers: VAROCE -12062012-002214-38
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Breast Cancer

Keywords

locally recurrent or metastatic breast cancer; Docetaxel; Nintedanib

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)

  6-months progression free disease

  baseline, every 9 weeks (or 3 cycles), up to 6 months

Secondary Outcomes (6)

• response rate

  baseline, every 9 weeks (or 3 cycles), up to 6 months

• overall survival

  up to 2 years

• quality of life by QLQ-C30 and additionnel module BR23

  baseline, every 9 weeks (or 3 cycles), up to 6 months

• biological markers levels in tumors and endothelial cells

  baseline, every 9 weeks (or 3 cycles), up to 6 months

• biological markers in patient serum

  baseline, every 9 weeks (or 3 cycles), up to 6 months

Study Arms (2)

Arm A

EXPERIMENTAL

Docetaxel + Nintedanib

Drug: Docetaxel; Drug: Nintedanib

Arm B

ACTIVE COMPARATOR

Docetaxel + increase of the dose

Drug: Docetaxel; Drug: Docetaxel: increase of the dose

Interventions

Docetaxel DRUG

75 mg/m2 IV Day 1 / 3 weeks

Also known as: Taxotere

Arm A; Arm B

Nintedanib DRUG

200 mg x 2 per os daily from D2\* \*No Nintedanib on days when docetaxel is administered

Also known as: OFEV

Arm A

Docetaxel: increase of the dose DRUG

Dose can be increased to 100 mg/m² secondarily at cycle 2 on the initiative of the investigator

Also known as: Taxotere

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Histologically or cytologically confirmed adenocarcinoma of the breast
• Locally recurrent or metastatic disease
• HER 2 negative status
• Requiring a first or a second-line chemotherapy for locally recurrent or metastatic disease.
• Prior first line chemotherapy not containing Docetaxel
• Measurable or evaluable disease according to RECIST 1.1 criteria
• Allowed prior chemotherapy as follows :
• Docetaxel in the neoadjuvant or adjuvant setting is allowed provided that relapse has been observed more than 12 months after the end of docetaxel treatment
• Bevacizumab in 1st line is allowed with a wash-out of 4 weeks, with recovery to NCI-CTCAE v3.0 toxicity
• ECOG performance status 0-1
• Adequate bone marrow, hepatic and renal functions as evidence by the following:
• Hemoglobin ≥ 10 G/100 mL
• Neutrophils count ≥ 1500 /mm3
• Platelets ≥ 100 000 /mm3

You may not qualify if:

• Concomitant hormone therapy for metastatic breast cancer
• Patients with dysphagia, or inability to swallow the tablets
• Other serious illness or medical conditions: Cardiac disease
• Unstable diabetes
• Uncontrolled hypercalcemia
• Pregnancy or breast feeding woman
• Unable for medical follow-up (geographic, social or mental reasons)
• Prior treatment with Nintedanib or any other VEGFR inhibitor
• Known hypersensitivity to the trial drugs , to their excipients, to peanut, to soya or to contrast media
• Contra indication to the use of the backbone treatment and to the comparator
• Active brain metastases (e.g. stable for \<4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
• Leptomeningeal disease
• Radiographic evidence of cavitary or necrotic tumors
• Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
• History of clinically significant haemorrhagic or thromboembolic event in the past 6 months

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Boehringer Ingelheim: collaborator

Study Sites (12)

CHU Amiens- Hôpital Sud

Amiens, 80 054, France

Location

Hôpital Privé les Bonnettes

Arras, 62000, France

Location

Centre Pierre Curie

Beuvry, 62660, France

Location

CH Compiègne-Noyon

Compiègne, 60200, France

Location

Centre Léonard de Vinci

Dechy, 59 187, France

Location

Centre Oscar Lambret

Lille, 59 020, France

Location

Polyclinique de Limoges - site Chénieux

Limoges, 87039, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

CMCO de la Côte d'Opale

Saint-Martin-Boulogne, 62280, France

Location

Hôpital Bretonneau

Tours, 37044, France

Location

Nouvelle Clinique des Dentellières

Valenciennes, 59300, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54 500, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; nintedanib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jacques BONNETERRE, MD PhD

  Oscar Lambret Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 7, 2012
• Study Start: May 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: October 30, 2017
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)