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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Bevacizuamb, Abraxane, Carboplatin, Doxorubicin, Cyclophosphamide	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Carboplatin Paclitaxel Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by Brown University:

Primary Outcome Measures:

To determine clinical & path. resp. rates, particularly pCR/near pCR rate,in HER2(-) stage IIA-IIIB Br. Ca with add. of Avastin 10 mg/kg q2weeks to either carboplatin/weekly Abraxane follow by ddAC (cohort1)or carboplatin/weekly Abraxane alone(cohort2). [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the toxicities of these regimens, and whether those toxicities affect treatment delivery, including complications of surgery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental Carboplatin AUC 6 q3wks with Abraxane 100 mg/m2 weekly x 12 and Avastin 10 mg/kg q2wks followed by Doxorubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 IV q2weeks and Avastin 10 mg/kg q2wks x 4 cycles (omit Avastin with cycle 4) followed by surgery followed by Avastin 10mg/kg q2wks X 16	Drug: Bevacizuamb, Abraxane, Carboplatin, Doxorubicin, Cyclophosphamide Carboplatin AUC 6 q3wks, Abraxane 100 mg/m2 weekly, Avastin 10 mg/kg q2wks, Doxorubicin 60 mg/m2 q2wks, Cyclophosphamide 600 mg/m2 q2wks
Cohort 2: Experimental Carboplatin AUC 6 q3wks with Abraxane 100 mg/m2 weekly x 12 and Avastin 10 mg/kg q2wks (omit Avastin for final 2 wk cycle) followed by surgery followed by either (MD choice) a) doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 and Avastin 10 mg/kg q2wks x 4 followed by Avastin 10 mg/kg q2wks x 16 or b) Avastin 10 mg/kg q2wks x 20	Drug: Bevacizuamb, Abraxane, Carboplatin, Doxorubicin, Cyclophosphamide Carboplatin AUC 6 q3wks, Abraxane 100 mg/m2 weekly, Avastin 10 mg/kg q2wks, Doxorubicin 60 mg/m2 q2wks, Cyclophosphamide 600 mg/m2 q2wks

Detailed Description:

In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by FAC, the pCR rate in HER2(-) patients was 20%. Our 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%, we will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with our novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion

Histologically documented adenocarcinoma of the breast ANC >1000cells
Female; age > 18
Zubrod PS 0-1
Platelets > 100,000
Stage IIA-IIIB disease
Total bilirubin < 1.5 ULN
No evidence of 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

No Histologically documented adenocarcinoma of the breast No-ANC >1000cells
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723125

Contacts


Contact: Teresa A Kennedy, RN<CCRA	401-383-3000	Teresa_Kennedy@brown.edu

Contact: William Sikov, MD	401-793-7151

Locations


United States, Rhode Island
	Lifespan Hospitals	Recruiting
	Providence, Rhode Island, United States, 02903
	Contact: Teresa A Kennedy, RN 401-383-3000 Teresa_kennedy@brown.edu
	Contact: William Sikov, MD 401-793-7151
	Principal Investigator: William Sikov, MD

Sponsors and Collaborators

Brown University

Yale University

Norris Cotton Cancer Center

Investigators


Principal Investigator:	William Sikov, MD	Brown University

More Information

Responsible Party:	Miriam Hospital ( Dr. William Sikov )
Study ID Numbers:	BrUOG-BR-211A
First Received:	July 15, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00723125
Health Authority:	United States: Institutional Review Board

Keywords provided by Brown University:

Breast Cancer

Study placed in the following topic categories:

Skin Diseases

Paclitaxel

Breast Neoplasms

Carboplatin

Bevacizumab

Cyclophosphamide

Doxorubicin

Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Growth Substances

Mitosis Modulators

Physiological Effects of Drugs

Antimitotic Agents

Antibiotics, Antineoplastic

Angiogenesis Inhibitors

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Tubulin Modulators

Myeloablative Agonists

Growth Inhibitors

Angiogenesis Modulating Agents

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Antineoplastic Agents, Phytogenic

Alkylating Agents

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Brown University Yale University Norris Cotton Cancer Center
Information provided by:	Brown University
ClinicalTrials.gov Identifier:	NCT00723125