Phase 2
N=60
Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00723125 ↗Enrolled (actual)
60
Serious AEs
27.5%
Results posted
Aug 2014
Primary outcome: Primary: Pathological Complete Response Rates at Surgery — 16; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abraxane (Drug); Carboplatin (Drug); Avastin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- William Sikov MD
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathological Complete Response Rates at Surgery |
16; 2 | — |
| SECONDARY Number of Participants With Adverse Events |
15; 21 | — |
Summary
In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.
Eligibility Criteria
Eligibility criteria
Inclusion criteria
- Histologically documented adenocarcinoma of the breast
- ANC > 1000 cells
- Female; age > 18
- Zubrod PS 0-1
- Platelets > 100,000
- Stage IIA-IIIB disease
- Total bilirubin 30 ml/min
- Not pregnant or lactating
- Serum ALT 2 neuropathy
- Urine protein: creat ratio 9 gm/dl
- (FISH testing is required for all HER2 2-3+ tumors by IHC)
Exclusion criteria
- No Histologically documented adenocarcinoma of the breast
- No-ANC > 1000 cells
- Female; age 0-1
- Platelets 1.5 ULN
- metastatic disease
- Serum Creatinine > 1.5 gm/dl
- prior systemic therapy for breast cancer or Creat Cl > 30 ml/min
- pregnant or lactating
- Serum ALT > 2.0 ULN baseline > 2 neuropathy
- Urine protein: creat ratio >1.0
- HER2-positive
- Hemoglobin < 9 gm/dl
Data sourced from ClinicalTrials.gov (NCT00723125). 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.