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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723125
First Posted: July 28, 2008
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yale University
Information provided by (Responsible Party):
William Sikov, Brown University
  Purpose
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%.

Condition Intervention Phase
Breast Cancer Drug: Abraxane Drug: Carboplatin Drug: Avastin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by William Sikov, Brown University:

Primary Outcome Measures:
  • Pathological Complete Response Rates at Surgery [ Time Frame: at surgery approximately 5 months after initial treatment ]

Secondary Outcome Measures:
  • Measure of Safety and Tolerability According to CTC Version 3.0 [ Time Frame: 2 years ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: May 15, 2014
Primary Completion Date: May 15, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1

Avastin 10 mg/kg IV over 90 minutes day -14

Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10

Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles

Definitive surgery

Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks

Drug: Abraxane
Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks
Drug: Carboplatin
Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10
Drug: 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)
Experimental: Cohort 2

Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7

Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7

Definitive surgery

Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks

Drug: Abraxane
Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks
Drug: Carboplatin
Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10
Drug: 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)

Detailed Description:
See above brief summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723125


Locations
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Yale Smilow Cancer Center
New Haven, Connecticut, United States, 06519
United States, Rhode Island
Rhode Island Hsopital
Providence, Rhode Island, United States, 02903
Women and Infants
Providence, Rhode Island, United States, 02905
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
William Sikov
Yale University
Investigators
Principal Investigator: William Sikov, MD Brown University
  More Information

Responsible Party: William Sikov, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00723125     History of Changes
Other Study ID Numbers: BrUOG-BR-211A
First Submitted: July 15, 2008
First Posted: July 28, 2008
Results First Submitted: July 17, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 22, 2017
Last Verified: July 2017

Keywords provided by William Sikov, Brown University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Bevacizumab
Albumin-Bound Paclitaxel
Paclitaxel
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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