Know Cancer

forgot password

Efficacy & Safety of Bevacizumab as Neoadjuvant Treatment in Patients With Locally Advanced Inflammatory Breast Cancer, a Pilot Study.

Phase 1
20 Years
75 Years
Open (Enrolling)
Inflammatory Breast Cancer

Thank you

Trial Information

Efficacy & Safety of Bevacizumab as Neoadjuvant Treatment in Patients With Locally Advanced Inflammatory Breast Cancer, a Pilot Study.

Pilot study evaluating the safety and efficacy of adding Bevacizumab to neoadjuvant
chemotherapy in patients presenting non metastatic inflammatory breast cancer (IBC).
Patients will receive 4 cycles of chemotherapy FEC100 associating Fluorouracil (500 mg/m2),
Epirubicin (100 mg/m2), Cyclophosphamide (500 mg/m2) and Bevacizumab 15 mg/kg every at day 1
of ecah 21 days cycle for 4 cycles. Six weeks after the end of neoadjuvant chemotherapy,
patients will undergo mastectomy and 4 cycles of Docetaxel (100 mg/m2)as adjuvant
chemotherapy +/-Trastuzumab 8 mg/kg for the first cycle then 6mg/kg every 3 weeks for 17
cycles if tumor overexpress Human Epidermal Growth Factor Receptor 2 (HER2).

The primary objective of this study is to evaluate the safety and the efficacy, i.e.
pathologic complete response (pCR) after 4 cycles of FEC100+Bevacizumab in IBC

Inclusion Criteria:

- • Patients must have signed a written informed consent form prior to any study
specific procedures,

- Women,

- 20 years or older,

- Performance status < 2 (ECOG),

- Histologically confirmed inflammatory breast cancer T4d any N,

- hormonal Status known,

- no metastases according to the last TNM classification,

- adequate hematologic function :

- absolute neutrophil count ≥ 1 500/mm3

- Platelets ≥ 100 000/mm3

- Hemoglobin ≥ 9 g/dL

- adequate liver function :

- ASAT and ALAT < à 3 ULN

- Alkaline Phosphatase < 5 ULN

- Total bilirubin < 1,5 ULN, o

- adequate kidney function :

- creatinine < 1,5 x normal or creatinine Clearance ≥ 50ml/min (according to
the cockcroft and Gault formula)

- Urine Dipstick for proteinuria < 2+ patients who have proteinuria ≥ 2 + on
dipstick urinalysis at baseline should undergo a 24 hours urine collection
and must demonstrate ≤ 1 g of protein in 24 hours,

- adequate coagulation and cardiac function :

- Prothrombin ratio ≥ 70 % and,

- Prothrombin time ≤ 1,5 upper limit of normal (ULN) within 7 days prior to

- Left Ventricular ejection fraction (LVEF) ≥ 55 %

Exclusion Criteria:

- Patients of childbearing potential with a positive pregnancy test (serum or urine)
prior to enrollment

- Patients who are either not post-menopausal, or surgically sterile, not using
"effective contraception" (the definition of "effective contraception" will be based
on the judgment of the investigator)

- Patients who are pregnant or breastfeeding

- Patient considered socially or psychological unable to comply with the treatment and
the required medial follow-up,

- Concurrent participation in another clinical trial or treatment with any other
anticancer agent during the protocol specified period

- Patients unwilling or unable to sign and date an Ethics Committee (EC)/ Institutional
Review Board (IRB)-approved patient informed consent form

- Patients unwilling or unable to comply with scheduled visits, treatment plans,
laboratory tests, and other study procedures

- Non inflammatory breast cancer with lymphatic skin permeation, Metastases,

- Bilateral breast cancer

- Distant metastases (stage IV)

- History of another cancer other than adequately treated carcinoma in situ of the
cervix uteri, basal or squamous cell skin cancer

- Prior anti tumor therapy (surgery, radiotherapy, chemotherapy, hormonal treatment and
targeted therapy) except treatments given for carcinoma in situ of the cervix uteri,
basal or squamous cell skin cancer

- History or evidence of inherited bleeding diathesis or coagulopathy,

- History of thrombotic disorders within the last 6 months prior to enrollment (i.e.
cerebrovascular accident, transient ischemic attacks, subarachnoid hemorrhage),

- Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)with or
without any anti-hypertensive medication ; patients with high initial blood pressure
are eligible if entry criteria are met after initiation or adjustment of
anti-hypertensive medication,

- Any of the following within 6 months prior to enrollment:

myocardial infarction, severe/unstable angina, or coronary/peripheral artery bypass graft
surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically
significant cardiac arrhythmias (grade 3-4)

- Severe resting dyspnea due to complications or oxygen dependency,

- Diabetic patient treated with oral anti-diabetics or insulin with an underlying
cardiopathy at ultrasound,

- Any other severe acute illness such as active uncontrolled infections that would
preclude the safe administration of study therapy at the time of the enrolment

- Other severe underlying medical conditions, which could impair the ability to
participate in the study

- Major surgery, significant traumatic injury within 28 days prior to study treatment
start or anticipation of the need for major surgery during study treatment,

- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior
to the first bevacizumab infusion,

- Non-healing wound, active peptic ulcer or bone fracture,

- History of abdominal fistula, diagnosed with a trachea-oesophageal fistula or any
grade 4 non gastro-intestinal fistula, gastrointestinal perforation or
intra-abdominal abscess within 6 months of enrolment,

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic Complete Response (pCR)

Outcome Description:

Evaluation of the pathologic complete response (pCR) rate among patients treated by 4 cycles of FEC100 and bevacizumab

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

amel mezlini, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Salah Azaiz


Tunisia : Direction de la pharmacie et du médicament

Study ID:




Start Date:

March 2011

Completion Date:

April 2017

Related Keywords:

  • Inflammatory Breast Cancer
  • bevacizumab
  • inflammatory breast cancer
  • non metastatic
  • Avastin
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms