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Inflammatory Breast CancerPhase 1BevaNCT01880385

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

A Phase 1 study testing Bevacizumab, Cyclophosphamide and epirubicin hydrochloride in people with Inflammatory Breast Cancer, run by Association Tunisienne de lutte Contre le Cancer at 1 site in Tunisia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years, women only
Conditions the study is for
Inflammatory Breast Cancer
What is being tested?
Bevacizumab, Cyclophosphamide and epirubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTunisia
Study dates
Mar 2011to Apr 2017
Phase
Phase 1
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 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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,
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  • 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 %

Who cannot join

  • 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
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  • 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,

Trial locations and contacts

1 site in 1 country.

ghozlane lakhoua contact

0021698354190

ghozlane_lakhoua@hotmail.fr

Tunisia1 site, 1 recruiting

  • Institut Salah Azaiz

    Bab Saadoun, Tunis Governorate, 1006+

    ghozlane lakhoua, 00 216 98 354 190, ghozlane_lakhoua@hotmail.fr

    henda raies, professor

    Recruiting

Other trials in Tunisia

About this study

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

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.

Read the 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

Being tested
Bevacizumab, Cyclophosphamide, epirubicin hydrochloride, fluorouracil, Docetaxel
Keywords
bevacizumab, inflammatory breast cancer, non metastatic, Avastin
Medical subject headings
Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called Avastin

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

  • CyclophosphamideDrug

    Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles

  • epirubicin hydrochlorideDrug

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

  • fluorouracilDrug

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

  • DocetaxelDrug

    Adjuvant: 100 mg/m2 q3w, 4 cycles

  • TrastuzumabBiological

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

Study groups in NCT01880385
Study groupRoleWhat they receive
bevacizumab, inflammatory breast cancerExperimentalNeoadjuvant 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
Receives: Biological: Bevacizumab; Drug: Cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil; Drug: Docetaxel; Biological: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pathologic Complete Response (pCR)

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

    Measured: 18 months

Secondary outcomes (3)

  1. Toxicity as assessed by CTCAE v3.0

    Evaluation of the safety of administering bevacizumab in the neoadjuvant setting, with particular attention on the incidence of grade 3/4 adverse events

    Measured: 3 and 5 years

  2. Progression-free survival

    Measured: 3 and 5 years

  3. Overall survival

    Measured: 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2013 (estimated)
  2. Study startMar 2011
  3. Primary completionSep 2013 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01880385
Sponsor's protocol ID
ML25168
Acronym
Beva
Status last verified
Jun 2013
First submitted
25 May 2011
Last updated
19 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16391297

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bevacizumab, Cyclophosphamide and epirubicin hydrochloride in people with Inflammatory Breast Cancer, run by Association Tunisienne de lutte Contre le Cancer at 1 site in Tunisia.

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 22 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ghozlane lakhoua (0021698354190, ghozlane_lakhoua@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic Complete Response (pCR) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880385, which also lists 1 linked publication.

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 19 Jun 2013.

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