Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Breast Cancer Research Foundation
Roche Pharma AG
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00347438
First received: June 29, 2006
Last updated: September 4, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery.

The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.


Condition Intervention Phase
Breast Cancer
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • overall, partial, clinical complete and pathological complete response rate [ Time Frame: indefinite ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • genomic markers of response [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • toxicity and adverse events [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: September 2006
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine
Capecitabine will be given at 1000mg/m2 twice daily for 2 weeks x 8 cycles, with a one-week pause in-between cycles.
Drug: Capecitabine
Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347438

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Nigeria
University of Ibadan
Ibadan, Nigeria
Obafemi Awolowo University
Ile-Ife, Nigeria
Sponsors and Collaborators
University of Chicago
Breast Cancer Research Foundation
Roche Pharma AG
Investigators
Principal Investigator: Olufunmilayo I Olopade, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00347438     History of Changes
Other Study ID Numbers: 14201B
Study First Received: June 29, 2006
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board
Nigeria: Institutional Review Board

Keywords provided by University of Chicago:
breast cancer
neoadjuvant
locally advanced

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014