Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Brea… (NCT01093235) | Clinical Trial Compass
UnknownPhase 3
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer
United Kingdom800 participantsStarted 2009-04
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Hemogl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete pathological response rates (tumor and lymph nodes)
Trial details
NCT IDNCT01093235
SponsorCambridge University Hospitals NHS Foundation Trust