Brief 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. 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

106

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline

Completed

Started Oct 2008

Longer than P75 for not_applicable breast-cancer

Geographic Reach

2 countries

8 active sites

Status

completed

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

6.9 years study duration

Study Start

First participant enrolled

October 1, 2008

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed

Last Updated

August 1, 2019

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

May 30, 2009

Last Update Submit

July 31, 2019

Conditions

Breast Cancer

Keywords

estrogen receptor-negative breast cancerestrogen receptor-positive breast cancerHER2-negative breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancermale breast cancer

Outcome Measures

Primary Outcomes (2)

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)
5 years
Measurements of left ventricular ejection fraction by echocardiography or MUGA
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)

Non comparative efficacy by disease-free and overall survival
5 years
Topo II overexpression
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.

Study Arms (1)

cyclophosphamide, Docetaxel, bevacizumab

EXPERIMENTAL

Biological: bevacizumabDrug: cyclophosphamideDrug: docetaxelProcedure: adjuvant therapy

Interventions

bevacizumabBIOLOGICAL

cyclophosphamide, Docetaxel, bevacizumab

cyclophosphamideDRUG

cyclophosphamide, Docetaxel, bevacizumab

docetaxelDRUG

cyclophosphamide, Docetaxel, bevacizumab

adjuvant therapyPROCEDURE

cyclophosphamide, Docetaxel, bevacizumab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The patient must have histologically confirmed, invasive adenocarcinoma of the breast with:
Involvement of at least one axillary lymph node on routine histologic examination.
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.
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
+11 more criteria

You may not qualify if:

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
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.
+9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Cancer Trials Irelandlead