Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT00194792
Phase
PHASE2
Status
Terminated

Conditions

  • Estrogen Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer

Eligibility Criteria

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

Interventions

  • exemestane — DRUG
    Given PO
  • triptorelin pamoate — DRUG
    Given IM
  • capecitabine — DRUG
    Given PO
  • methotrexate — DRUG
    Given IV
  • vinorelbine tartrate — DRUG
    Given IV
  • paclitaxel — DRUG
    Given IV
  • therapeutic conventional surgery — PROCEDURE
    Undergo lumpectomy or mastectomy
  • radiation therapy — RADIATION
    Undergo radiation therapy
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, 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 hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery

Key Dates

Start date
Aug 31, 2005
Status verified
Jun 2017
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: Treatment (hormone therapy and chemotherapy)
    See detailed description

Primary Outcome Measure

Number of Participants With Clinical Response [ Time Frame: 1 month ]

Locations (1)

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

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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

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