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Efficacy and Safety of Bevacizumab in the Neodjuvant Treatment of Inflammatory Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Association Tunisienne de lutte Contre le Cancer
Sponsor:
Collaborators:
Hoffmann-La Roche
Sanofi
Information provided by (Responsible Party):
Association Tunisienne de lutte Contre le Cancer
ClinicalTrials.gov Identifier:
NCT01880385
First received: May 25, 2011
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

Multi-center, non randomised, open label, non controlled pilot study. Evaluating the treatment of bevacizumab in association with pre-operative chemotherapy, followed by surgery, adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.


Condition Intervention Phase
Inflammatory Breast Cancer
Biological: Bevacizumab
Drug: Cyclophosphamide
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: Docetaxel
Biological: Trastuzumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy & Safety of Bevacizumab as Neoadjuvant Treatment in Patients With Locally Advanced Inflammatory Breast Cancer, a Pilot Study.

Resource links provided by NLM:


Further study details as provided by Association Tunisienne de lutte Contre le Cancer:

Primary Outcome Measures:
  • pathologic Complete Response (pCR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Evaluation of the pathologic complete response (pCR) rate among patients treated by 4 cycles of FEC100 and bevacizumab


Secondary Outcome Measures:
  • Toxicity as assessed by CTCAE v3.0 [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
    Evaluation of the safety of administering bevacizumab in the neoadjuvant setting, with particular attention on the incidence of grade 3/4 adverse events

  • Progression-free survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bevacizumab, inflammatory breast cancer
Neoadjuvant therapy associating bevacizumab, cyclophosphamide, fluorouracil and epirubicin hydrochloride q3w, 4 cycles Adjuvant therapy by docetaxel q3w, 4 cycles +/- trastuzumab q3w, 18 cycles if tumors overexpress HER2
Biological: Bevacizumab
During neoadjuvant phase: 15 mg/kg, d1 q3w, 4 cycles
Other Name: Avastin
Drug: Cyclophosphamide
Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles
Drug: epirubicin hydrochloride
Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles
Drug: fluorouracil
Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles
Drug: Docetaxel
Adjuvant: 100 mg/m2 q3w, 4 cycles
Biological: Trastuzumab
Adjuvant: 8 mg/kg d1 in the 1st cycle then 6 mg/kg for d1 q3w, 17 cycles if tumor overexpress HER2

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 enrolment
      • 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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880385

Contacts
Contact: ghozlane lakhoua 0021698354190 ghozlane_lakhoua@hotmail.fr

Locations
Tunisia
Institut Salah Azaiz Recruiting
Bab Saadoun, Tunis, Tunisia, 1006+
Contact: ghozlane lakhoua    00 216 98 354 190    ghozlane_lakhoua@hotmail.fr   
Sub-Investigator: henda raies, professor         
Sponsors and Collaborators
Association Tunisienne de lutte Contre le Cancer
Hoffmann-La Roche
Sanofi
Investigators
Principal Investigator: amel mezlini, professor Institut Salah Azaiz
  More Information

Publications:
Responsible Party: Association Tunisienne de lutte Contre le Cancer
ClinicalTrials.gov Identifier: NCT01880385     History of Changes
Other Study ID Numbers: ML25168
Study First Received: May 25, 2011
Last Updated: June 14, 2013
Health Authority: Tunisia : Direction de la pharmacie et du médicament

Keywords provided by Association Tunisienne de lutte Contre le Cancer:
bevacizumab
inflammatory breast cancer
non metastatic
Avastin

Additional relevant MeSH terms:
Inflammatory Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Trastuzumab
Bevacizumab
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014