Breast Cancer Clinical Trial

Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer

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%.

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Full Description

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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 < 1.5 ULN
No evidence of any metastatic disease
Serum Creatinine < 1.5 gm/dl
No prior systemic therapy for breast cancer or Creat Cl > 30 ml/min
Not pregnant or lactating
Serum ALT < 2.0 ULN
ER, PR and HER2 status required
LVEF (MUGA/echo WNL)
No baseline > 2 neuropathy
Urine protein: creat ratio < 1.0
HER2-negative - either IHC 0-1+ or FISH ratio < 2.0
Hemoglobin > 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 < 18
Zubrod PS > 0-1
Platelets < 100,000
Stage IV disease
Total bilirubin > 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00723125

Recruitment Status:

Completed

Sponsor:

William Sikov MD

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There are 5 Locations for this study

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Bridgeport Hospital
Bridgeport Connecticut, 06610, United States
Yale Smilow Cancer Center
New Haven Connecticut, 06519, United States
Rhode Island Hsopital
Providence Rhode Island, 02903, United States
Women and Infants
Providence Rhode Island, 02905, United States
The Miriam Hospital
Providence Rhode Island, 02906, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00723125

Recruitment Status:

Completed

Sponsor:


William Sikov MD

How clear is this clinincal trial information?

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