Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen

Part of paid clinical trials in Detroit, Michigan.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00118157
Phase
PHASE2
Status
Completed

Conditions

  • Estrogen Receptor Positive
  • Male Breast Carcinoma
  • Progesterone Receptor Positive
  • Recurrent Breast Carcinoma
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

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

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Lapatinib Ditosylate — DRUG
    Given PO
  • Tamoxifen Citrate — DRUG
    Given PO

Study Details

This phase II trial studies how well giving lapatinib ditosylate together with tamoxifen citrate works in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other areas of the body and did not respond to previous treatment with tamoxifen citrate. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Sometimes when tamoxifen citrate is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to tamoxifen citrate. Giving lapatinib ditosylate together with tamoxifen citrate may reduce drug resistance and allow the tumor cells to be killed.

Key Dates

Start date
May 31, 2005
Status verified
Oct 2017
Primary completion
Jul 31, 2011
Completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Treatment (lapatinib, tamoxifen)
    Patients receive lapatinib ditosylate PO daily and tamoxifen citrate PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 4 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Harper University Hospital - DMCDetroitMichigan48201-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Detroit, MI

By research site
Harper University Hospital - DMC· Detroit, MIWayne State University/Karmanos Cancer Institute· Detroit, MI

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