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Monoclonal Antibodies

Doxil, Paclitaxel, Cyclophosphamide + Avastin for Breast Cancer

Phase 2
Waitlist Available
Led By John Carpenter, M.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This study will evaluate the rate of pathological complete response (pCR) to the sequential therapy of Doxil, paclitaxel, and cyclophosphamide with concurrent Avastin for patients with locally advanced invasive (T2,T3, Nany, M0) breast carcinoma. Also, the study will evaluate the clinical and subclinical cardiotoxic effect(s) of this regimen, assess how feasible and safe the study is. Survival without any progression of disease will also be calculated. A regimen of chemotherapy will be given to replicate the high rate of pCR seen with conventional chemotherapy in patients with locally advanced breast cancer. Doxil will substitute the normally given doxorubicin. It is expected that the low effect or minimal effect of Doxil on cardiac function will minimize any additional risk of cardiotoxicity from Avastin. It is expected that clinical and subclinical rates of cardiotoxicity will be very low at the total doses to be given in this clinical trial.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Achievement of Pathological Complete Response (pCR)
Secondary study objectives
Assess Toxicities of Regimen Including Hand Foot Syndrome
Calculate Progression Free Survival
Number of Participant With Clinical or Subclinical Cardiotoxicity

Side effects data

From 2015 Phase 2 trial • 32 Patients • NCT00635050
72%
hand-foot syndrome
53%
rash
22%
hypertension
19%
neutropenia
3%
hospitalization
3%
mucositis
3%
proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doxil, Paclitaxel, Cyclophosphamide + Avastin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Doxil, Paclitaxel, Cyclophosphamide + AvastinExperimental Treatment1 Intervention
Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, in patients with locally advanced invasive breast cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,943 Total Patients Enrolled
33 Trials studying Breast Cancer
4,521 Patients Enrolled for Breast Cancer
Ortho Biotech, Inc.Industry Sponsor
32 Previous Clinical Trials
2,483 Total Patients Enrolled
1 Trials studying Breast Cancer
102 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,332 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
~2 spots leftby Sep 2025
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