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Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00194779
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Hannah Linden, University of Washington

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Estrogen Receptor-negative Breast Cancer
Estrogen Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Progesterone Receptor-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Interventions: Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: paclitaxel
Biological: filgrastim
Drug: capecitabine
Drug: methotrexate
Drug: vinorelbine tartrate
Procedure: needle biopsy
Procedure: therapeutic conventional surgery
Other: immunohistochemistry staining method
Biological: trastuzumab
Drug: tamoxifen citrate
Drug: letrozole
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)

See Detailed Description.

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

paclitaxel: Given IV

filgrastim: Given SC

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

needle biopsy: Correlative studies

therapeutic conventional surgery: Undergo definitive breast surgery

immunohistochemistry staining method: Correlative studies

trastuzumab: Given IV

tamoxifen citrate: Given PO

letrozole: Given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
STARTED   50 
COMPLETED   50 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)

See Detailed Description.

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

paclitaxel: Given IV

filgrastim: Given SC

capecitabine: Given PO

methotrexate: Given IV

vinorelbine tartrate: Given IV

needle biopsy: Correlative studies

therapeutic conventional surgery: Undergo definitive breast surgery

immunohistochemistry staining method: Correlative studies

trastuzumab: Given IV

tamoxifen citrate: Given PO

letrozole: Given PO

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Neoadjuvant Therapy, Adjuvant Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age [1] 
[Units: Years]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 45 
   47 
 (27 to 66) 
[1] Age data is missing from 5 patients
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 50 
Female      50 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 50 
Hispanic or Latino      2   4.0% 
Not Hispanic or Latino      40  80.0% 
Unknown or Not Reported      8  16.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 50 
American Indian or Alaska Native      0   0.0% 
Asian      5  10.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4   8.0% 
White      35  70.0% 
More than one race      0   0.0% 
Unknown or Not Reported      6  12.0% 


  Outcome Measures

1.  Primary:   Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)   [ Time Frame: Up to 16 weeks ]

2.  Secondary:   Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation   [ Time Frame: From the initiation of study treatments to 30 days after the end of neoadjuvant treatment or adjuvant treatment if received ]

3.  Secondary:   Correlation of Molecular Markers With Response   [ Time Frame: After completion of neoadjuvant therapy ]

4.  Secondary:   Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy   [ Time Frame: Up to 8 years ]

5.  Secondary:   Time to Progression   [ Time Frame: Up to 5 years ]

6.  Secondary:   OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN   [ Time Frame: 1, 2, and 5 years ]

7.  Secondary:   Disease-free Survival   [ Time Frame: 1, 2, and 5 years ]

8.  Secondary:   Clinical Response to Neoadjuvant Therapy   [ Time Frame: Up to 12 weeks ]

9.  Secondary:   Clinical Response to Paclitaxel   [ Time Frame: Up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Hannah Linden
Organization: University of Washington / Seattle Cancer Care Alliance
phone: 206-288-6989
e-mail: hmlinden@uw.edu



Responsible Party: Hannah Linden, University of Washington
ClinicalTrials.gov Identifier: NCT00194779     History of Changes
Other Study ID Numbers: 6278
NCI-2011-00934 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: April 14, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018