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Breast CancerNCT00911716

TC Avastin. ICORG 08-10, V6

A study testing bevacizumab, cyclophosphamide and docetaxel in people with Breast Cancer, run by Cancer Trials Ireland at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
bevacizumab, cyclophosphamide and docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
8 sitesin 2 countries
Study dates
Oct 2008to Sep 2015
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must have histologically confirmed, invasive adenocarcinoma of the breast with:
  • -Involvement of at least one axillary lymph node on routine histologic examination.
  • or
  • ER negative tumour >2 cm invasive cancer or
  • ER positive tumour > 3cm invasive cancer. Note : Pre-menopausal patients with ER positive tumour may participate in the International Breast Cancer Study Group (IBCSG) SOFT study. High risk and registered and intermediate risk and randomized for chemotherapy patients enrolled in the TAILOR x study may participate in this study (once prior approval from IBCSG and ECOG is received)
  • Patients must have undergone standard surgical treatment for their breast cancer, consisting either of mastectomy or a standard breast-conserving operation, which included appropriate axillary surgery. Such axillary procedures will include either sentinel node biopsy or an axillary dissection.
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  • Patients must have disease which is HER2 negative (0, or 1+ by immunohistochemistry (IHC) or fluorescence in situ hybridization FISH non amplified)
  • Patients must have negative evaluations for metastatic disease, including chest x-ray or CT scan, isotope bone scan, and either computed tomography (CT), MRI or ultrasound of the liver. Position emission tomography (PET) scan would also suffice in place of the above tests (unless a bone scan is clinically indicated) within 3 months prior to registration.
  • Patients must have a normal cardiac ejection fraction by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 3 months prior to registration.
  • The electrocardiogram (ECG) performed within 3 months prior to registration must not have any clinically significant abnormalities reported.
  • Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS). Patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible.
  • The interval between the last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) and Day 1 of treatment must be > 21 days and no more than 84 days.
  • ECOG performance status of 0-1.
  • Patients must have adequate organ function within < 8 weeks prior to registration, as measured by:
  • Absolute neutrophil count > 1.2 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Normal bilirubin (except for patients with congenital hyperbilirubinemia)
  • total bilirubin must be ≤ upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2x ULN
  • Serum creatinine must be ≤ ULN for the lab
  • Measured or creatinine clearance must be ≥60ml/min
  • Urinary protein should be 0- 1+ on dipstick urinalysis. If dipstick reading is ≥_2+ protein value must be < 500 mg in a 24-hour urine specimen.
  • Activated partial thromboplastin time (APTT) < 1.5 x ULN
  • Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher tumour node metastasis (TNM) stage tumour meets the eligibility criteria for this study and both are HER-2 negative.
  • Male or female patients age > 18 years of age are eligible.
  • Women must not be pregnant or breast-feeding due to the potential harmful effects of bevacizumab on the developing fetus. (Note: All females of childbearing potential must have a serum pregnancy test within 7 days prior to registration).
  • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception ( such as non hormonal intra uterine device (IUD), condoms, sexual abstinence or vasectomized partner).

Who cannot join

  • Any active serious medical illness.
  • Patients must not have clinically significant cardiovascular or cerebrovascular disease, including any history of
  • Symptomatic heart disease or heart disease requiring ongoing treatment
  • Cerebrovascular disease including transient ischemic attack (TIA), stroke or subarachnoid haemorrhage
  • Ischemic bowel
  • Myocardial infarction
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  • Unstable angina
  • New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Grade II or greater peripheral vascular disease active at study entry
  • Patients receiving anticoagulation therapy are excluded.
  • Uncontrolled hypertension defined as systolic blood pressure (BP) >145mmHg or diastolic BP >85mmHg, with or without anti-hypertensive medication.(BP must be assessed within 28 days prior to registration).
  • Uncontrolled or clinically significant arrhythmia.
  • Clinical evidence of inflammatory breast cancer or fixed axillary nodes at diagnosis.
  • Any major surgical procedure within 21 days of day 1 treatment. (NOTE: Non-operative biopsy or placement of a vascular access device is not considered a major surgery).
  • Placement of a vascular access device within 24 hours of planned Day 1 of treatment.
  • Bleeding diathesis, hereditary or acquired bleeding disorder or coagulopathy.
  • A non-healing wound or fracture. Patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration are not eligible.
  • Axillary node involvement only demonstrated by immunohistochemistry are not eligible unless they meet one of the other eligibility criteria below:
  • ER negative tumour >2 cm invasive cancer
  • ER positive tumour > 3 cm invasive cancer
  • Prior cancer except for basal cell skin cancer and cancer in situ of the cervix and uterus
  • Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
  • Patients must not have received prior cytotoxic chemotherapy for any cancer or received hormonal therapy for this breast cancer.
  • NOTE: Prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry. Similarly, prior raloxifene use is allowed but must be discontinued at study entry.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Ireland7 sites

  • Cancer Trials Ireland Investigative Site

    Dublin, 24

  • Cancer Trials Ireland Investigative Site

    Dublin, 4

  • Cancer Trials Ireland Investigative Site

    Dublin

  • Cancer Trials Ireland Investigative Site

    Galway

  • Cancer Trials Ireland Investigative Site

    Limerick

  • Cancer Trials Ireland Investigative Site

    Sligo

  • Cancer Trials Ireland Investigative Site

    Waterford

Other trials in Ireland

Denmark1 site

  • Dept. of Oncology; Rigshospitalet

    Blegdamsvej, Copenhagen

Other trials in Denmark

About this study

Official title: Pilot Evaluation of Bevacizumab, in Combination With Docetaxel and Cyclophosphamide in the Adjuvant Treatment of Patients With HER 2 Negative Breast Cancer

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bevacizumab may kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects of giving bevacizumab together with docetaxel and cyclophosphamide and to see how well it works in treating patients with early-stage high-risk breast cancer.

This is a single arm, non randomised pilot study investigating the safety of the combination of Docetaxel + Cyclophosphamide+ Bevacizumab in the adjuvant treatment of patients with early stage, HER 2 negative, high risk breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Assess the feasibility of the combination of adjuvant bevacizumab, docetaxel, and cyclophosphamide in patients with early-stage HER2-negative high-risk breast cancer.
  • Determine the safety of this regimen with regards to cardiac toxicity, hypertension, and bleeding complications in these patients.

Secondary

  • Evaluate the efficacy of this regimen by measuring Topo II overexpression in these patients.

OUTLINE: This is a multicenter study.

Patients will receive 4 cycles of Docetaxel 75mg/m2 + 4 cycles of Cyclophosphamide 600mg/m2 (each cycle lasts 21 days) (+/- 3 days if a due date could not be met because of public holidays, etc) and concomitant Avastin (Bevacizumab) 15mg/kg q 3weeks for treatment duration of one year.

Bevacizumab at a dose of 15mg/kg will be administered as an intravenous infusion every 3 weeks for a treatment period of one year, regardless of missed doses.

Patients will be followed up through 5 years (i.e. from the time of registration through to end of Year 5/ 1 year treatment and 4 years follow up).

Conditions
Breast Cancer
Keywords
estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, HER2-negative breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male

What participants receive

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

Study groups in NCT00911716
Study groupRoleWhat they receive
cyclophosphamide, Docetaxel, bevacizumabExperimentalNot described
Receives: Biological: bevacizumab; Drug: cyclophosphamide; Drug: docetaxel; Procedure: adjuvant therapy

What is being measured

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

  1. Percentage of patients experiencing heart failure

    Patients will be followed up through 5 years (i.e. from the time of registration through to end of Year 5 / 1 year treatment and 4 years follow up)

    Measured: 5 years

  2. Measurements of left ventricular ejection fraction by echocardiography or MUGA

    Measured: Sceening, day 1 of cycles 3, 5, 9, 13'.(the window of 5 days in advance to 1st day of treatment is allowed), end of treatment, follow- up annually

Secondary outcomes (2)

  1. Non comparative efficacy by disease-free and overall survival

    Measured: 5 years

  2. Topo II overexpression

    Measured: Serum samples for assssment of Topo II overexpression collected prior to commencement of treatment, after cycle 4, at 6 months, 1 year and 12 months post last dose of bevacizumab.

Timeline

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

  1. First posted2 Jun 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2010
  4. Study completionSep 2015

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911716
Sponsor's protocol ID
08-10 ICORG
Other IDs
ICORG-08-10, EUDRACT-2008-004552-76, EU-20915
Status last verified
Oct 2015
First submitted
30 May 2009
Last updated
1 Aug 2019
Results posted
No

Publications

  • Gullo G, J Eustace A, Canonici A, M Collins D, Kennedy MJ, Grogan L, Breathhnach O, McCaffrey J, Keane M, Martin MJ, Gupta R, Leonard G, O'Connor M, Calvert PM, Donnellan P, Walshe J, McDermott E, Scott K, Hernando A, Parker I, W Murray D, C O'Farrell A, Maratha A, Dicker P, Rafferty M, Murphy V, O'Donovan N, M Gallagher W, Ky B, Tryfonopoulos D, Moulton B, T Byrne A, Crown J. Pilot study of bevacizumab in combination with docetaxel and cyclophosphamide as adjuvant treatment for patients with early stage HER-2 negative breast cancer, including analysis of candidate circulating markers of cardiac toxicity: ICORG 08-10 trial. Ther Adv Med Oncol. 2019 Jul 24;11:1758835919864236. doi: 10.1177/1758835919864236. eCollection 2019.

    PubMed 31384312

Questions about this trial

What is this clinical trial studying?

A study testing bevacizumab, cyclophosphamide and docetaxel in people with Breast Cancer, run by Cancer Trials Ireland at 8 sites in 2 countries.

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 27 inclusion and 24 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: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Ireland, Denmark. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients experiencing heart failure (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT00911716, 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 1 Aug 2019.

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