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 range18 Years
SexFEMALE
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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…
What they're measuring
1
Percentage of Participants With Pathological Complete Response.
Timeframe: Participants were assessed during surgery, an average of one hour