NCT01106898

Brief Summary

This phase II trial studies the side effects and how well giving cyclophosphamide and paclitaxel with or without trastuzumab works in treating patients with stage I-II breast cancer who have undergone surgery. Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy, such as trastuzumab, with chemotherapy may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

March 24, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 31, 2018

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

5.5 years

First QC Date

April 13, 2010

Results QC Date

April 30, 2018

Last Update Submit

September 13, 2023

Conditions

Stage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerStage IIB Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival

    Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.

    Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years

Study Arms (1)

Treatment (chemotherapy with or without maintenance therapy)

EXPERIMENTAL

SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.

Drug: cyclophosphamideDrug: paclitaxelBiological: trastuzumabOther: laboratory biomarker analysis

Interventions

cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Treatment (chemotherapy with or without maintenance therapy)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (chemotherapy with or without maintenance therapy)
trastuzumabBIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2
Treatment (chemotherapy with or without maintenance therapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (chemotherapy with or without maintenance therapy)

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed newly diagnosed stage I-II breast cancer
  • Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
  • Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Absolute neutrophil count greater than or equal to 1,500/mcl
  • Platelet count equal to or greater than 150,000/mcl
  • Hemoglobin \> 11 gm/dl
  • Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)
  • Total bilirubin equal to or less than 1.5 times the ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN
  • Creatinine less than 1.5 times the ULN
  • Able to give informed consent
  • All included patients must have normal cardiac function as defined by an ejection fraction of \> 50% by echocardiogram
  • Able to return for treatment and follow-up on the specified days

You may not qualify if:

  • Prior malignancy; except for adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas
  • Patients with preexisting grade II peripheral neuropathy
  • Patients with prior chemotherapy
  • Stage IV or metastatic breast cancer
  • Pregnant or nursing women
  • Inability to cooperate with treatment protocol
  • No active serious infections or other conditions precluding chemotherapy
  • Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol (e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc.)
  • Known hypersensitivity to any component of required drugs in the study
  • Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active hepatitis
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiograph (ECG) abnormality at screening has to be documented by the investigator as not medically relevant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint Francis Medical Center

Grand Island, Nebraska, 68803, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CyclophosphamidePaclitaxelTaxesTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Elizabeth Reed
Organization
University of Nebraska Medical Center
ereed@unmc.edu
402-559-5166

Study Officials

  • Elizabeth C Reed

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 20, 2010

Study Start

March 24, 2010

Primary Completion

September 28, 2015

Study Completion

September 28, 2015

Last Updated

September 28, 2023

Results First Posted

May 31, 2018

Record last verified: 2023-09

Locations

US(2)