NCT00944047

Brief Summary

The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2 breast-cancer

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

July 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 23, 2018

Completed
Last Updated

April 23, 2018

Status Verified

March 1, 2018

Enrollment Period

4.8 years

First QC Date

July 16, 2009

Results QC Date

March 21, 2018

Last Update Submit

March 21, 2018

Conditions

Breast Cancer

Keywords

invasive breast cancerHER2primary breast cancerneo-adjuvant therapyTrastuzumabNab-paclitaxel

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response

    22 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery

Drug: nab-paclitaxelDrug: trastuzumabDrug: DoxorubicinDrug: cyclophosphamideBiological: Growth Factor SupportProcedure: Surgery

Interventions

nab-paclitaxelDRUG

100 MG/M2 IV over 30 minutes once a week for 12 weeks

Also known as: Abraxane
Intervention Arm
trastuzumabDRUG

4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks

Also known as: Herceptin
Intervention Arm
DoxorubicinDRUG

60 MG/M2 every two weeks for a total of 4 cycles

Also known as: Adriamycin
Intervention Arm
cyclophosphamideDRUG

600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)

Also known as: Cytoxan
Intervention Arm
Growth Factor SupportBIOLOGICAL

* All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle. * Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.

Intervention Arm
SurgeryPROCEDURE

* After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy. * All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patient ≥ 18 years of age
  • Histologically proven stage II or III adenocarcinoma of the breast
  • Must be candidate for neoadjuvant treatment (Tumor size ≥ 2 cm, T2, T3, T4 and/or clinical N1 or N2).
  • HER-2/neu 1+ or 2+ by immunohistochemistry
  • Must have operable tumor.
  • Performance status of 2 or better per SWOG criteria
  • LVEF ≥ 55% by echocardiogram performed within 4 weeks prior to treatment initiation
  • If patient of childbearing potential, pregnancy test is negative
  • Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.
  • Adequate bone marrow function: ANC \> 1500/mm3, platelet count \> 100,000/mm3, and hemoglobin \> 9 g/dL
  • Adequate kidney function: serum creatinine of \< 1.5mg/dl and/or creatinine clearance of \> 60 mL/min
  • Adequate hepatic function: transaminases \< 2.5 x upper limit of normal and total bilirubin \< 1.5 mg/dL
  • Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.
  • Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.

You may not qualify if:

  • Patient with metastatic breast cancer.
  • Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry
  • Women with HER 2 FISH amplified tumors (FISH ratio \>2.2)
  • Patients who have had prior endocrine therapy for \> 4 weeks or chemotherapy for this breast cancer will be excluded.
  • Locally advanced, inoperable tumors will be excluded.
  • The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.
  • History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
  • Ejection fraction \< 55%
  • Pregnancy or lactation
  • Patients with inadequate laboratory values (as defined above) are excluded from study.
  • Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.
  • Patients with active infection are excluded from study.
  • Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).
  • Patients with emotional limitations are excluded from study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hays Medical Center

Hays, Kansas, 67601, United States

Location

University of Kansas Medical Center Cancer Center

Kansas City, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelTrastuzumabDoxorubicinCyclophosphamideSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Dr. Qamar Khan
Organization
University of Kansas Cancer Center
ctnursenav@kumc.edu
(913) 588-6029

Study Officials

  • Qamar Khan, MD

    University of Kansas Medical Center Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

July 16, 2009

First Posted

July 22, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2014

Study Completion

August 1, 2017

Last Updated

April 23, 2018

Results First Posted

April 23, 2018

Record last verified: 2018-03

Locations

US(2)