NCT01880385

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

May 25, 2011

Last Update Submit

June 14, 2013

Conditions

Inflammatory Breast Cancer

Keywords

bevacizumabinflammatory breast cancernon metastaticAvastin

Outcome Measures

Primary Outcomes (1)

  • pathologic Complete Response (pCR)

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

    18 months

Secondary Outcomes (3)

  • Toxicity as assessed by CTCAE v3.0

    3 and 5 years

  • Progression-free survival

    3 and 5 years

  • Overall survival

    3 and 5 years

Study Arms (1)

bevacizumab, inflammatory breast cancer

EXPERIMENTAL

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: BevacizumabDrug: CyclophosphamideDrug: epirubicin hydrochlorideDrug: fluorouracilDrug: DocetaxelBiological: Trastuzumab

Interventions

BevacizumabBIOLOGICAL

During neoadjuvant phase: 15 mg/kg, d1 q3w, 4 cycles

Also known as: Avastin
bevacizumab, inflammatory breast cancer
CyclophosphamideDRUG

Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles

bevacizumab, inflammatory breast cancer
epirubicin hydrochlorideDRUG

Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles

bevacizumab, inflammatory breast cancer
fluorouracilDRUG

Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles

bevacizumab, inflammatory breast cancer
DocetaxelDRUG

Adjuvant: 100 mg/m2 q3w, 4 cycles

bevacizumab, inflammatory breast cancer
TrastuzumabBIOLOGICAL

Adjuvant: 8 mg/kg d1 in the 1st cycle then 6 mg/kg for d1 q3w, 17 cycles if tumor overexpress HER2

bevacizumab, inflammatory breast cancer

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have signed a written informed consent form prior to any study specific procedures,
  • Women,
  • 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
  • +7 more criteria

You may not qualify if:

  • 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,
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Salah Azaiz

Bab Saadoun, Tunis Governorate, 1006+, Tunisia

RECRUITING

Related Publications (1)

  • Wedam SB, Low JA, Yang SX, Chow CK, Choyke P, Danforth D, Hewitt SM, Berman A, Steinberg SM, Liewehr DJ, Plehn J, Doshi A, Thomasson D, McCarthy N, Koeppen H, Sherman M, Zujewski J, Camphausen K, Chen H, Swain SM. Antiangiogenic and antitumor effects of bevacizumab in patients with inflammatory and locally advanced breast cancer. J Clin Oncol. 2006 Feb 10;24(5):769-77. doi: 10.1200/JCO.2005.03.4645. Epub 2006 Jan 3.

    PMID: 16391297BACKGROUND

MeSH Terms

Conditions

Inflammatory Breast Neoplasms

Interventions

BevacizumabCyclophosphamideEpirubicinFluorouracilDocetaxelTrastuzumab

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • amel mezlini, professor

    Institut Salah Azaiz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ghozlane lakhoua

CONTACT

0021698354190ghozlane_lakhoua@hotmail.fr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 19, 2013

Study Start

March 1, 2011

Primary Completion

September 1, 2013

Study Completion

April 1, 2017

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

TU(1)