Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer (NCT00203502) | Clinical Trial Compass
CompletedPhase 2
Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer
United States40 participantsStarted 2005-09
Plain-language summary
The main purpose of this study is to find out what effects taking the drug bevacizumab together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve weeks in combination with chemotherapy then it ill be held during the administration of doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will receive nine three-weekly infusions of bevacizumab.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The diagnosis of breast cancer established by biopsy.
* Normal kidney function
* Normal LVEF evaluated by MUGA Scan
* \>18 years of age
* Good performance status defined by ECOG scale of 0 or 1
* Consent
* Women of childbearing potential must have a negative pregnancy test.
* Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.
* Peripheral Neuropathy: must be \< grade 1
* Hematologic (minimal values)
* Absolute neutrophil count \>1,500/mm3
* Hemoglobin \>8.0 g/dl
* Platelet count \>100,000/mm3
* Hepatic
* Total bilirubin \<ULN
* AST, ALT, Alkaline Phosphatase must be within range
Exclusion Criteria:
* Patients with locally advanced breast cancer with skin ulcerations
* Stage IV breast cancer
* Inflammatory breast cancer
* Allergy to any component of the treatment regimen
* Women who are breast feeding
* Pregnancy or refusal to use effective contraception
* Inability to comply with study and/or follow-up procedures.
* Current, recent, or planned participation in a experimental drug study
* Blood pressure of \>150/100 mmHg. Essential hypertension well controlled with anti hypertensives is not an exclusion criterion.
* unstable angina
* New York Heart Association Grade II or greater congestive heart failure
* history of myocardial infarction within 6 months
* history of stroke within 6 months
* Clinical significant peripheral vascular disease
* Evidence of bleeding diathe…
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
Percentage of Participants With Pathological Complete Response.
Timeframe: Participants were assessed during surgery, an average of one hour