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A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer


Phase 2
18 Years
90 Years
Not Enrolling
Female
BREAST CANCER

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Trial Information

A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer


We want to determine the effects of Herceptin and to determine its efficacy in women with
HER-2 overexpressing advanced breast cancer. The end-points will include the comparison of
an array of histologic and molecular markers from sequential core biopsies of primary breast
cancers of patients receiving Herceptin.

The other aim of this study would be to determine clinical response to therapy with
Herceptin and Taxotere.


Inclusion Criteria:



- All patients must be female.

- Informed consent must be signed.

- Women with locally advanced breast cancers or primary breast cancers with concomitant
gross metastatic disease are eligible. Locally advanced cancers must be of clinical
and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.

- Her2/neu overexpressing tumors defined as HercepTest score of 3+, or >/= one-third of
invasive tumor showing membranous staining, or fluorescence in situ hybridization
(FISH) positive.

- Negative serum pregnancy test (bHCG) within 7 days of starting study, if of
child-bearing potential.

- Kidney and liver function tests - all within 1.5 times of the institution's upper
limit of normal.

- Performance status (World Health Organization [WHO] scale) < 2 and life expectancy >
6 months.

- Age > 18.

- No metastatic disease without concomitant primary breast cancer.

- No previous or current malignancies at other sites within the last 5 years, with
exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri
and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

- Pregnancy or unwillingness to use a reliable contraceptive method in women of
child-bearing potential.

- Severe underlying chronic illness or disease.

- Cardiomyopathy or baseline left ventricular ejection fraction (LVEF) < 50%.

- Patients on other investigational drugs while on study.

- Severe or uncontrolled hypertension defined as blood pressure (BP) > 180/100 on three
separate occasions.

- History of congestive heart failure.

- History of coronary arterial disease.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Mothaffar Rimawi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Breast Center, Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

H-10379

NCT ID:

NCT00133796

Start Date:

October 2001

Completion Date:

April 2007

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Advanced Breast Cancer
  • Breast Neoplasms

Name

Location

Baylor Breast CenterHouston, Texas  77030