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A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB (BIBF-1120) in Patient Receiving a Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer

Phase 2
18 Years
Not Enrolling
Locally Recurrent or Metastatic Breast Cancer

Thank you

Trial Information

A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB (BIBF-1120) in Patient Receiving a Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer

Inclusion Criteria:

- Age ≥ 18 years old

- Histologically or cytologically confirmed adenocarcinoma of the breast

- Locally recurrent or metastatic disease

- HER 2 negative status

- Prior first line chemotherapy not containing Docetaxel

- Relapsing after a first line chemotherapy for locally recurrent or metastatic disease

- Measurable or evaluable disease according to RECIST criteria

- 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

- Bevacizumab in 1st line is allowed with a wash-out of 3 months

- 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)

- 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) of 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) within 1 week prior to start of study
treatment in females of 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

Exclusion Criteria:

- Symptomatic brain metastasis

- 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

- Clinically significant active infections

- Pregnancy or breast feeding woman

- Unable for medical follow-up (geographic, social or mental reasons)

- Prior treatment with Nintedanib or any other VEGFR inhibitor or stratify if trial
aims to establish anti-angiogenic retreatment

- Known hypersensitivity to the trial drugs , to their excipients 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

increase in the progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)

Outcome Description:

6-months progression free disease

Outcome Time Frame:

baseline, every 3 weeks, up to 6 months

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:

Oscar Lambret Center


France: Committee for the Protection of Personnes

Study ID:

VAROCE - 1206



Start Date:

November 2012

Completion Date:

June 2016

Related Keywords:

  • Locally Recurrent or Metastatic Breast Cancer
  • Breast cancer
  • Docetaxel
  • Nintedanib
  • Breast Neoplasms