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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:September 2008
End Date:May 15, 2014

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Q3week Carboplatin With Weekly Abraxaneä And Avastin + Subsequent Dose-Dense Ac With Avastin As Neoadjuvant Therapy In Resectable And Unresectable (Stage Iia-Iiib) Her2-Negative Breast Cancer

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%.

See above brief summary

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
We found this trial at
5
sites
Bridgeport, Connecticut 06610
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111 Goose Lane
New Haven, Connecticut 06437
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New Haven, CT
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593 Eddy Street
Providence, Rhode Island 02903
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Providence, RI
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Providence, Rhode Island 02905
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Providence, RI
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Providence, RI
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