Phase 2
N=40
Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00203502 ↗Enrolled (actual)
40
Serious AEs
100.0%
Results posted
Jan 2016
Primary outcome: Primary: Percentage of Participants With Pathological Complete Response. — 41 percentage of evaluable patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Cyclophosphamide (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Arkansas
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pathological Complete Response. |
41 | — |
| SECONDARY Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab. |
53 | — |
| SECONDARY Percentage of Participants With Grade 3 or 4 Adverse Events |
79 | — |
| SECONDARY To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline |
-3.5 | — |
| SECONDARY Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer |
57 | — |
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.
Eligibility Criteria
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 1,500/mm3
- Hemoglobin >8.0 g/dl
- Platelet count >100,000/mm3
- Hepatic
- Total bilirubin 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 diathesis or coagulopathy
- Presence of central nervous system or brain metastasis
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0
- Minor surgical procedure such as fine needle aspirations or core biopsy within 7 days prior to day 0
- Pregnant or lactating
- Urine protein: creatinine ratio >1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
Data sourced from ClinicalTrials.gov (NCT00203502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.