Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

NCT00347438 | Terminated Phase 2 Results DMC

• 1 other identifier: 14201B
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer; neoadjuvant; locally advanced

Outcome Measures

Primary Outcomes (4)

• Overall Clinical Response Rate (OCR)

  Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.

  After the first three cycles of therapy, an average of 9 weeks

• Partial Clinical Response Rate (PR)

  Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.

  After the first three cycles of therapy, an average of 9 weeks

• Complete Clinical Response Rate (CCR)

  Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.

  After the first three cycles of therapy, an average of 9 weeks

• Complete Pathologic Response Rate (cPR)

  Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.

  After the first three cycles of therapy, an average of 9 weeks

Study Arms (1)

Capecitabine

EXPERIMENTAL

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

Interventions

Capecitabine DRUG

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).

Also known as: Xeloda

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• Breast Cancer Research Foundation: collaborator
• Roche Pharma AG: collaborator

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Ibadan

Ibadan, Nigeria

Location

Obafemi Awolowo University

Ile-Ife, Nigeria

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Funmi Olopade
• Organization: University of Chicago Medical Center

folopade@medicine.bsd.uchicago.edu

773-702-1632

Study Officials

• Olufunmilayo I Olopade, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: July 4, 2006
• Study Start: September 1, 2006
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 14, 2015
• Results First Posted: December 14, 2015

Record last verified: 2015-11

Locations

NG (2); US (1)