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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723125
• Other study ID #: BrUOG-BR-211A
• Status: Completed
• Phase: Phase 2
• Start date: September 2008
• Est. completion date: May 15, 2014

Study information

• Verified date: April 2021
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Description:

See above brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2014
• Est. primary completion date: May 15, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Abraxane
Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks
• Carboplatin
Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10
• Avastin
Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Yale Smilow Cancer Center	New Haven	Connecticut
United States	Rhode Island Hsopital	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	Women and Infants	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
William Sikov MD	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response Rates at Surgery		at surgery approximately 5 months after initial treatment
Secondary	Number of Participants With Adverse Events	Measure of safety and tolerability according to CTCAE version 3.0	2 years