NCT00518583

Brief Summary

The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

2.3 years

First QC Date

August 16, 2007

Last Update Submit

January 14, 2010

Conditions

Breast Cancer

Keywords

Breast cancerOver-expressing Her2-neu

Outcome Measures

Primary Outcomes (1)

  • Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab

    within 18 weeks

Secondary Outcomes (5)

  • Identify the complete response rate

    within 18 weeks

  • Identify the partial response rate

    within 18 weeks

  • Identify the overall response rate

    within 18 weeks

  • Evaluate changes in cardiac function

    within study participation

  • Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen

    within study participation

Interventions

Pegylated Liposomal Doxorubicin (Doxil)DRUG

Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly

Also known as: taxol (paclitaxel), herceptin

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dx of clinical T1c-T3, N0-1, M0 breast cancer
  • Interval between diagnosis and consent of \<- 62 days
  • Life expectancy of 10 years
  • LVEF by MUGA \>= lower limit of normal for the testing facility
  • Negative serum pregnancy test
  • Adequate bone marrow, renal, liver function
  • Negative bone scan
  • HRT discontinued before study entry
  • Adequate contraceptive methods

You may not qualify if:

  • Male breast cancer
  • Less than 21 years of age
  • Ulceration, infiltration of the skin, complete fixation or severe skin edema
  • N3 disease in which nodes are matted and fixed
  • Suspicious palpable supraclavicular nodes
  • CT evidence of malignant internal mammary nodes
  • Pregnancy or breast feeding at time of study entry
  • Prior therapy for breast cancer
  • Prior anthracycline for any malignancy
  • Prior breast malignancy of the contralateral breast
  • Prior non-breast malignancy within 5 years
  • Non-malignant disease that would preclude follow up
  • MI within 6 months, NYHA Class II or greater heart failure
  • Psychiatric disorders or conditions that would preclude provision of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Providence St. Joseph Medical Hospital

Burbank, California, 91505, United States

Location

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, 90048, United States

Location

Desert Regional Medical Center Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

Lynn Regional Cancer Center West

Boca Raton, Florida, 33486, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Maimonides Cancer Center

Brooklyn, New York, 11220, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

St Vincent Comprehensive Cancer Center

New York, New York, 10011, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinPaclitaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • John Macdonald, MD

    CMO Aptium Oncology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

October 1, 2006

Primary Completion

January 1, 2009

Study Completion

September 1, 2009

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(9)