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A PHASE II STUDY OF THE CLINICAL AND BIOLOGIC EFFECTS OF DOCETAXEL (TAXOTERE) IN PATIENTS WITH LOCALLY ADVANCED BREAST CANCER


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A PHASE II STUDY OF THE CLINICAL AND BIOLOGIC EFFECTS OF DOCETAXEL (TAXOTERE) IN PATIENTS WITH LOCALLY ADVANCED BREAST CANCER


Systemic chemotherapy for operable breast cancer significantly decreases the risk of relapse
and death. However, it is not possible to identify those patients at the outset who are
likely to respond to adjuvant treatment and which type of treatment should be used. Adjuvant
treatment given before surgery (neoadjuvant therapy) has a number of theoretical advantages
in breast cancer, including a reduction in the requirement for mastectomy. Access to the
primary tumor during early treatment allows for in vivo testing for change in molecular
markers by repeat biopsies that may occur with successful treatment. Established prognostic
factors like tumor size and nodal involvement are important indicators for breast cancer
relapse and survival but have not been shown to be predictive of sensitivity to treatment.
Estrogen receptor (ER) and progesterone receptor (PgR) expression predict for response to
tamoxifen and endocrine treatment. However, predictive markers for chemotherapy are not
established. Overexpression of c-erbB-2 has been associated with decreased response to CMF
chemotherapy (cyclophosphamide, methotrexate, and 5-fluorouracil) in most studies.
Accumulation of aberrant protein expressed by the mutated tumor suppressor gene p53 product
may be associated with relative resistance to cytotoxic therapy. Tissue growth kinetics are
determined by the balance between programmed cell death (apoptosis) and cell proliferation,
and any alteration between the two may be regarded as a key element for the uncontrolled
growth of malignant tumors. In vitro experiments suggest that many anti-cancer agents
achieve their effect by inducing apoptosis. Mechanisms that suppress this process may,
therefore, be important in the development of intrinsic and acquired chemotherapy
resistance. A clinical study has reported an increase in labeled apoptotic leukemic cells
during treatment. In breast cancer biopsy specimens, chemotherapy was found to induce
apoptosis within the first 24 hours of treatment.

Measurement of biological molecular markers before and after exposure may, therefore, allow
for early prediction of the likelihood of response to systemic therapy. Preoperative
chemotherapy has been shown to result in changes in biomarkers, and these changes, when
correlated with tumor response, may be early predictors of clinical outcome.

New treatment strategies are needed to improve the clinical outcome in breast cancer
patients at high risk of recurrence. Even with the best present combination chemotherapy,
radiotherapy, and surgery, disease recurrence and death is at least 60% in this population.
Thus, new strategies are needed to improve survival. Recent advances that may improve
clinical outcome include the use of taxoids (paclitaxel and docetaxel), a new class of
cytotoxic agents, with reported higher response rates than standard anthracycline-based
chemotherapy.


Inclusion Criteria:



- 1. All patients must be female. 2. Signed informed consent. 3. Locally advanced
breast cancers or primary breast cancers with concomitant metastatic disease are
eligible. Locally advanced cancers must be of clinical and/or radiologic size >4 cm
and/or are deemed surgically inoperable. 4. Negative serum pregnancy test within 7
days of starting study, if of child-bearing potential. 5. Adequate bone marrow
function: Hematocrit of greater than 30%, total neutrophil count must be >1.5 x
10(9)/L and platelets of >100 x 10(9)/L prior to the start of any cycle. 6. Kidney
function tests - within 1.5 times of the institution's upper limit of normal. Total
serum bilirubin within upper limit of normal. 7. Electrocardiogram showing no acute
ischemic changes. 8. Performance status (WHO scale) <2 (Appendix I) and life
expectancy >1 year. 9. Age > 18 years. 10. No brain and/or leptomeningeal disease.
11. 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:

- 1. Pregnancy or unwillingness to use reliable contraceptive method in women of
child-bearing potential. 2. Severe underlying chronic illness or disease. 3.
Peripheral neuropathy - grade 2 or greater. 4. Patients on other investigational
drugs while on study will be excluded. 5. Severe or uncontrolled hypertension,
history of congestive heart failure, or severe coronary arterial disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy of neoadjuvantTaxotere in patients with locally advanced breast cancer. Histological complete response rate

Principal Investigator

Jenny Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Breast Center

Authority:

United States: Food and Drug Administration

Study ID:

H 8448

NCT ID:

NCT00206505

Start Date:

January 1999

Completion Date:

July 2004

Related Keywords:

  • Breast Cancer
  • Breast
  • Cancer
  • Neoadjuvant
  • Taxotere
  • Breast Neoplasms

Name

Location

Baylor Breast CenterHouston, Texas  77030