Breast CancerPhase 2VAROCENCT01658462
Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer
A Phase 2 study testing Docetaxel, Nintedanib and Docetaxel: increase of the dose in people with Breast Cancer, run by Centre Oscar Lambret at 12 sites in France.
Trial summary
National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel, Nintedanib and Docetaxel: increase of the dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 12 sitesFrance
- Study dates
- May 2013to 30 Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Total bilirubin ≤ ULN (ULN:Upper Limit of Normal)
- SGOT/SGPT ≤ 1.5 x ULN (≤ 2.5 x ULN in case of hepatic metastasis)
- Serum alkaline phosphatase ≤ 2.5 x ULN
- Creatinin clearance ≥ 45 ml/min or creatinin ≤ 1.5 x ULN
- Proteinuria < CTCAE grade 2
- Coagulation parameters: International normalised ratio (INR) ≤ 2, prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 50% of deviation of institutional ULN
- Effective contraception for patients (male and female) with reproductive potential during their entire participation in the study and during 3 months after the last administration of Nintedanib or Docetaxel
- Negative pregnancy test (serum beta-HCG) performed within 1 week prior to start of study treatment in females with reproductive potential
- Patient covered by government health insurance
- Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation
Who cannot join
- 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
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- 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
- Known inherited predisposition to bleeding or thrombosis
- Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
- Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix
- Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
- Active or chronic hepatitis C and/or B infection
- Active alcohol or drug abuse
- Significant weight loss (> 10% of BW) within past 6 months prior to inclusion into the trial
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU Amiens- Hôpital Sud
Amiens, 80 054
Hôpital Privé les Bonnettes
Arras, 62000
Centre Pierre Curie
Beuvry, 62660
CH Compiègne-Noyon
Compiègne, 60200
Centre Léonard de Vinci
Dechy, 59 187
Centre Oscar Lambret
Lille, 59 020
Polyclinique de Limoges - site Chénieux
Limoges, 87039
Institut Jean Godinot
Reims, 51056
CMCO de la Côte d'Opale
Saint-Martin-Boulogne, 62280
Hôpital Bretonneau
Tours, 37044
Nouvelle Clinique des Dentellières
Valenciennes, 59300
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54 500
About this study
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
National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer.
Read the 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
- Being tested
- Docetaxel, Nintedanib, Docetaxel: increase of the dose
- Keywords
- locally recurrent or metastatic breast cancer, Docetaxel, Nintedanib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
75 mg/m2 IV Day 1 / 3 weeks
NintedanibDrug
Also called OFEV
200 mg x 2 per os daily from D2*
*No Nintedanib on days when docetaxel is administered
Docetaxel: increase of the doseDrug
Also called Taxotere
Dose can be increased to 100 mg/m² secondarily at cycle 2 on the initiative of the investigator
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Docetaxel + Nintedanib Receives: Drug: Docetaxel; Drug: Nintedanib |
| Arm B | Active comparator | Docetaxel + increase of the dose Receives: Drug: Docetaxel; Drug: Docetaxel: increase of the dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)
6-months progression free disease
Measured: baseline, every 9 weeks (or 3 cycles), up to 6 months
Secondary outcomes (6)
response rate
according to RECIST 1.1
Measured: baseline, every 9 weeks (or 3 cycles), up to 6 months
overall survival
time from the date of randomization to the date of death from any cause
Measured: up to 2 years
quality of life by QLQ-C30 and additionnel module BR23
questionnaire : EORTC QLQ C30 (Additional module BR23)
Measured: baseline, every 9 weeks (or 3 cycles), up to 6 months
biological markers levels in tumors and endothelial cells
biological analysis of cells RT-qPCR analysis, including endothelial cells using a specific reference gene
Measured: baseline, every 9 weeks (or 3 cycles), up to 6 months
biological markers in patient serum
biological analysis in patient's serum Dosage of VEGF-A, -C, FGF-1, -2, PDGF-AA, -AB, -BB in patient's serum
Measured: baseline, every 9 weeks (or 3 cycles), up to 6 months
safety profile of Nintedanib
according to NCI CTCAE v3.0
Measured: before each cycle, 3 weeks after the last dose or at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startMay 2013
- Primary completion31 Dec 2016
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Jacques BONNETERRE, MD PhD, Study director, Oscar Lambret Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658462
- Sponsor's protocol ID
- VAROCE-1206
- Other IDs
- 2012-002214-38
- Acronym
- VAROCE
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2012
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01658462
- Acronym / sponsor ID
- VAROCE / VAROCE-1206
- Conditions
- Breast Cancer
- Keywords
- locally recurrent or metastatic breast cancer, Docetaxel, Nintedanib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- May 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Docetaxel, Drug: NintedanibDocetaxel + Nintedanib |
| Arm B | Active comparator | Drug: Docetaxel, Drug: Docetaxel: increase of the doseDocetaxel + increase of the dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere75 mg/m2 IV Day 1 / 3 weeks | Drug | Arm A, Arm B |
| NintedanibAlso: OFEV200 mg x 2 per os daily from D2* *No Nintedanib on days when docetaxel is administered | Drug | Arm A |
| Docetaxel: increase of the doseAlso: TaxotereDose can be increased to 100 mg/m² secondarily at cycle 2 on the initiative of the investigator | Drug | Arm B |
Primary outcome
Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)
Time frame: baseline, every 9 weeks (or 3 cycles), up to 6 months
6-months progression free disease
6 secondary outcomes
response rate
Time frame: baseline, every 9 weeks (or 3 cycles), up to 6 months
overall survival
Time frame: up to 2 years
quality of life by QLQ-C30 and additionnel module BR23
Time frame: baseline, every 9 weeks (or 3 cycles), up to 6 months
biological markers levels in tumors and endothelial cells
Time frame: baseline, every 9 weeks (or 3 cycles), up to 6 months
biological markers in patient serum
Time frame: baseline, every 9 weeks (or 3 cycles), up to 6 months
safety profile of Nintedanib
Time frame: before each cycle, 3 weeks after the last dose or at the end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques BONNETERRE, MD PhD study director
Oscar Lambret Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Nintedanib and Docetaxel: increase of the dose in people with Breast Cancer, run by Centre Oscar Lambret at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B) (time frame: baseline, every 9 weeks (or 3 cycles), up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.