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 |
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%.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
Click here to add this to my saved trials