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Breast CancerPhase 3NCT01093235

Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer

A Phase 3 study testing bevacizumab, cyclophosphamide and docetaxel in people with Breast Cancer and Cardiac Toxicity, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bevacizumab, cyclophosphamide and docetaxel
Type of treatment
Surgery or procedure
How many people
800 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2009to Apr 2012
Phase
Phase 3
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer
  • HER2-negative disease
  • IHC 0/1 OR IHC 2+ and FISH negative
  • Must meet 1 of the following criteria:
  • Unifocal tumor meeting 1 of the following criteria:
  • T2 or T3 tumors (radiological size > 20 mm)
  • T4 tumor of any size with direct extension to the chest wall or the skin
  • Inflammatory carcinoma with tumor of any size
  • Multifocal tumor meeting the following criteria:
  • The sum of each tumors' maximum diameter must be ≥ 20 mm (total radiological tumor size ≥ 20 mm)
  • Other locally advanced disease meeting 1 of the following criteria:
  • Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter > 20 mm or clinical N2) and primary breast tumor of any diameter
  • Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter > 20 mm or clinical N2), without a primary breast tumor identified and the presence of breast cancer in a lymph node must be histopathologically confirmed by lymph node biopsy (tru-cut or whole lymph node)
  • Embedded paraffin tumor block available from pre-chemotherapy biopsy and surgical specimen
  • Bilateral disease allowed
  • No evidence of metastatic disease
  • No prior breast cancer except for ductal carcinoma in situ of the breast surgically cured > 10 years ago
  • Any hormone receptor status

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • WBC > 3 x 10^9/L
  • Hemoglobin > 10 g/dL
  • Platelet count > 100 x 10^9/L
  • AST/ALT ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • Bilirubin normal
  • Isolated elevation of bilirubin to ≤ 3 times ULN with a presumptive diagnosis of Gilbert syndrome allowed if AST/ALT and alkaline phosphatase are within normal limits
  • Creatinine ≤ 1.5 times ULN
  • PT and PTT/aPTT ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • Must be fit to receive chemotherapy on this trial, in the opinion of the responsible clinician, as indicated by the following criteria:
  • No clinically significant cardiac abnormalities
  • No myocardial infarction within the past 6 months
  • LVEF normal (at least 50%) by MUGA scan or echocardiogram
  • No prior ischemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, inflammatory bowel disease, gastroduodenal ulcer, symptomatic diverticulitis, or bleeding diathesis
  • No uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg) with or without antihypertensive medication
  • Patients with initial blood pressure elevations are eligible provided initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria
  • No other previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast treated by surgery only and disease-free for 10 years
  • No concurrent medical or psychiatric problem that might prevent completion of treatment or follow-up
  • No presence of active uncontrolled infection
  • No history of nephritic or nephrotic syndrome
  • No traumatic injury within the past 28 days
  • No evidence of other disease that, in the opinion of the investigator, places the patient at high risk of treatment-related complications
  • No nonhealing wound, peptic ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

  • No prior neoadjuvant endocrine therapy
  • No prior chemotherapy or radiotherapy
  • No major surgical procedure within the past 28 days
  • No concurrent full therapeutic dose of anticoagulants or aspirin > 325 mg/day, clopidogrel > 75 mg/day, or corticosteroids

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

    Contact Person, 44-1223-336-800, Hme22@cam.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: ARTemis - Avastin Randomized Trial With Neo-Adjuvant Chemotherapy for Patients With Early Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, 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) may kill more tumor cells. 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. It is not yet known whether giving combination chemotherapy together with or without bevacizumab is more effective in treating patients with nonmetastatic breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy works compared with giving combination chemotherapy together with bevacizumab in treating patients with nonmetastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the efficacy of neoadjuvant therapy comprising docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide with versus without bevacizumab in patients with HER2-negative nonmetastatic breast cancer.

Secondary

  • To assess quality of life of female patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 50 years old vs > 50 years old), estrogen receptor status (negative [Allred score 0-2] vs weakly positive [Allred score 3-5] vs strongly positive [Allred score 6-8]), total tumor size* (≤ 50 mm vs > 50 mm), clinical involvement of axillary nodes (yes vs no), and inflammatory/locally advanced disease (T4) (yes vs no). Patients are randomized to 1 of 2 treatment arms.

NOTE: *In cases with multifocal disease in one breast, or bilateral disease, the size to be used for the stratification is the sum of the single largest diameter of all measurable tumors.

  • Arm I: Patients receive docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1 (FEC). Treatment with fluorouracil, epirubicin hydrochloride, and cyclophosphamide repeats every 3 weeks for 3 courses.
  • Arm II: Patients receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive FEC as in arm I. Treatment with FEC repeats every 3 weeks for 3 courses. Patients also receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1 in FEC course 1 only.

Within 3-6 weeks after completion of last dose of study therapy, patients in both arms undergo surgery. Within 4-8 weeks after surgery, patients undergo radiotherapy according to standard protocol.

Women complete quality-of-life questionnaires (FACT-B and EuroQoL) at baseline and during and after completion of study treatment.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

Being tested
bevacizumab, cyclophosphamide, docetaxel, epirubicin hydrochloride, fluorouracil
Keywords
cardiac toxicity, perioperative/postoperative complications, HER2-negative breast cancer, male breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer
Medical subject headings
Breast Neoplasms, Cardiotoxicity, Postoperative Complications, Breast Neoplasms, Male, Inflammatory Breast Neoplasms

What participants receive

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

What is being measured

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

  1. Complete pathological response rates (tumor and lymph nodes)

Secondary outcomes (7)

  1. Disease-free survival

  2. Overall survival

  3. Pathological complete response rate in breast alone

  4. Radiological response after 3 and 6 courses of chemotherapy

  5. Rate of breast conservation

  6. Toxicities, including cardiac safety and surgical complications (wound healing, bleeding, and thrombosis)

  7. Quality of life

Timeline

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

  1. First posted25 Mar 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionApr 2012 (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 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093235
Sponsor's protocol ID
CDR0000668530
Other IDs
CRCA-CCTC-WCTU-ARTemis, ISRCTN68502941, EUDRACT-2008-002322-11, EU-21017, MREC-08/H1102/104
Status last verified
Mar 2010
First submitted
24 Mar 2010
Last updated
25 Mar 2010
Results posted
No

Publications

  • Ali HR, Dariush A, Thomas J, Provenzano E, Dunn J, Hiller L, Vallier AL, Abraham J, Piper T, Bartlett JMS, Cameron DA, Hayward L, Brenton JD, Pharoah PDP, Irwin MJ, Walton NA, Earl HM, Caldas C. Lymphocyte density determined by computational pathology validated as a predictor of response to neoadjuvant chemotherapy in breast cancer: secondary analysis of the ARTemis trial. Ann Oncol. 2017 Aug 1;28(8):1832-1835. doi: 10.1093/annonc/mdx266.

    PubMed 28525534

  • Earl HM, Hiller L, Dunn JA, Blenkinsop C, Grybowicz L, Vallier AL, Gounaris I, Abraham JE, Hughes-Davies L, McAdam K, Chan S, Ahmad R, Hickish T, Rea D, Caldas C, Bartlett JMS, Cameron DA, Provenzano E, Thomas J, Hayward RL; ARTemis Investigators Group. Disease-free and overall survival at 3.5 years for neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin and cyclophosphamide, for women with HER2 negative early breast cancer: ARTemis Trial. Ann Oncol. 2017 Aug 1;28(8):1817-1824. doi: 10.1093/annonc/mdx173.

    PubMed 28459938

  • Earl HM, Hiller L, Dunn JA, Blenkinsop C, Grybowicz L, Vallier AL, Abraham J, Thomas J, Provenzano E, Hughes-Davies L, Gounaris I, McAdam K, Chan S, Ahmad R, Hickish T, Houston S, Rea D, Bartlett J, Caldas C, Cameron DA, Hayward L; ARTemis Investigators. Efficacy of neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide, for women with HER2-negative early breast cancer (ARTemis): an open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Jun;16(6):656-66. doi: 10.1016/S1470-2045(15)70137-3. Epub 2015 May 11.

    PubMed 25975632

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab, cyclophosphamide and docetaxel in people with Breast Cancer and Cardiac Toxicity, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 25 Mar 2010. 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 United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete pathological response rates (tumor and lymph nodes). 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 NCT01093235, which also lists 3 linked publications.

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 25 Mar 2010.

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