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

NCT00723125 | Completed Phase 2 Results DMC

• 1 other identifier: BrUOG-BR-211A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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%.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response Rates at Surgery

  at surgery approximately 5 months after initial treatment

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  2 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Avastin

Cohort 2

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Avastin

Interventions

Abraxane DRUG

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

Also known as: Paclitaxel Protein-Bound

Cohort 1; Cohort 2

Carboplatin DRUG

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

Also known as: Paraplatin

Cohort 1; Cohort 2

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)

Also known as: Bevacizumab

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Sikov MD: lead
• Yale University: collaborator

Study Sites (5)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Yale Smilow Cancer Center

New Haven, Connecticut, 06519, United States

Location

Rhode Island Hsopital

Providence, Rhode Island, 02903, United States

Location

Women and Infants

Providence, Rhode Island, 02905, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; Taxes; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Economics; Health Care Economics and Organizations; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: William Sikov, MD
• Organization: BrUOG

Roxanne_Wood@brown.edu

4018633000

Study Officials

• William Sikov, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 28, 2008
• Study Start: September 1, 2008
• Primary Completion: May 15, 2014
• Study Completion: May 15, 2014
• Last Updated: April 29, 2021
• Results First Posted: August 8, 2014

Record last verified: 2021-04

Locations

US (5)