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A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Phase II Study to Evaluate the Efficacy, Safety, and Genomic Markers of Response of Capecitabine as NeoAdjuvant Therapy in Women With Newly Diagnosed Locally Advanced Breast Cancer


Inclusion Criteria:



- Patients with locally advanced, histologically confirmed adenocarcinoma of the female
breast. Women with ulcerated breast lesions may be enrolled. Patients with
asymptomatic metastases to the bone are eligible.

- Ability to provide written informed consent prior to study-specific screening
procedures

- TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled.
Patients with large T2 tumors whose surgeons believe their results with breast
conserving surgery will be improved by neoadjuvant therapy may be enrolled.

- Age 18 years or older

- Negative serum or urine pregnancy test within 7 days prior to starting therapy
(female patients of childbearing potential).

- Performance status 0-1

- Required Initial Laboratory Data:

- Granulocytes >=1,200/µl

- Platelet count >=100,000/µl

- Calculated Creatinine Clearance > 30 mL/min

- Total bilirubin <= Upper Limit Normal

- Alkaline Phosphatase <=Upper Limit Normal

- SGPT, SGOT <=Upper Limit Normal

- Normal chest x-ray

Exclusion Criteria:

- HER2 positive breast cancer

- Pregnant or lactating woman

- Life expectancy < 3 months

- Serious, uncontrolled, concurrent infection(s)

- Any prior fluoropyrimidine therapy or other chemotherapy

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known
hyper-sensitivity to 5-fluorouracil or known DPD deficiency.

- Patients who have received more than four weeks of tamoxifen therapy for this
malignancy.

- Treatment for other carcinomas within the last five years, except cured non- melanoma
skin and treated in-situ cervical cancer.

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment.

- Evidence of metastatic disease to sites other than the bone or with symptomatic bone
lesions.

- Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation.

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome.

- Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and
Phenytoin

- Any of the following laboratory values:

- Abnormal hematologic values (neutrophils < 1.0 x 109/L, platelet count < 100 x 109/L)

- Impaired renal function (estimated creatinine clearance <30ml/min as calculated with
Cockcroft-Gault equation)

- Serum bilirubin > upper normal limit.

- SGOT, SGPT > upper normal limit

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall, partial, clinical complete and pathological complete response rate

Outcome Time Frame:

indefinite

Safety Issue:

No

Principal Investigator

Olufunmilayo I Olopade, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

14201B

NCT ID:

NCT00347438

Start Date:

September 2006

Completion Date:

August 2015

Related Keywords:

  • Breast Cancer
  • breast cancer
  • neoadjuvant
  • locally advanced
  • Breast Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637