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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT00194779
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • doxorubicin hydrochloride — DRUG
    Given IV
  • cyclophosphamide — DRUG
    Given PO
  • paclitaxel — DRUG
    Given IV
  • filgrastim — BIOLOGICAL
    Given SC
  • capecitabine — DRUG
    Given PO
  • methotrexate — DRUG
    Given IV
  • vinorelbine tartrate — DRUG
    Given IV
  • needle biopsy — PROCEDURE
    Correlative studies
  • therapeutic conventional surgery — PROCEDURE
    Undergo definitive breast surgery
  • immunohistochemistry staining method — OTHER
    Correlative studies
  • trastuzumab — BIOLOGICAL
    Given IV
  • tamoxifen citrate — DRUG
    Given PO
  • letrozole — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel before surgery may be an effective treatment for breast cancer

Key Dates

Start date
Oct 31, 2003
Status verified
Feb 2018
Primary completion
Jun 30, 2010
Completion
Jun 30, 2011

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (neoadjuvant therapy, adjuvant therapy)
    See Detailed Description.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

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