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NCT Number: NCT00723125

Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for 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%.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Bridgeport Hospital, Bridgeport, Connecticut, United States

Loading trial locations.

About this study

See above brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abraxane

Drug

Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks

Other names: Paclitaxel Protein-Bound

carboplatin

Drug

Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10

Other names: Paraplatin

Avastin

Drug

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)

Other names: Bevacizumab

Primary outcomes

  1. Pathological Complete Response Rates at Surgery

    Time frame: at surgery approximately 5 months after initial treatment

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 2 years

    Measure of safety and tolerability according to CTCAE version 3.0

Sponsors and collaborators

Lead sponsor

William Sikov MD

Other

Collaborators

  • Yale University

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2008
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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