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Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer (CAP7/7)

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ClinicalTrials.gov Identifier: NCT02028494
Recruitment Status : Unknown
Verified September 2018 by Latin American & Caribbean Society of Medical Oncology.
Recruitment status was:  Recruiting
First Posted : January 7, 2014
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Latin American & Caribbean Society of Medical Oncology

Brief Summary:

The purpose of this study is to compare the efficacy of a novel schedule of an oral anticancer drug, capecitabine, in patients with metastatic breast cancer.

Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is an optimal dosing schedule for this drug and previous studies done al Memorial Sloan Kettering Cancer Center support the tolerability of this scheme.

This definitive, randomized trial comparing the efficacy of the new dosage with the conventional dosing schedule in patients with metastatic breast cancer is necessary and we hypothesize it will be superior in terms of efficacy.

Dosing schedules based on mathematical predictions for optimal drug delivery based on efficacy rather than toxicity could facilitate more rapid and economical drug development. This trial is a proof of principle trial of the highest priority.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Capecitabine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer
Study Start Date : August 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A: Capecitabine 2,000 mg (flat dose)
Arm A: Capecitabine 2,000 mg (flat dose), orally, twice daily for 7 days followed by a 7 day rest (7-7) (4-week cycle length ).
Drug: Capecitabine
Two dosages comparison
Other Name: Xeloda

Active Comparator: Arm B: Capecitabine 1,000 mg/m2 twice daily for 14 day
Arm B: Capecitabine 1,000 mg/m2, orally, twice daily for 14 days followed by a 7 day rest (14-7) (3-week cycle length ). The control arm dose of capecitabine has been reduced from the US Food and Drug Administration approved dose of 1,250 mg/m2, orally, twice daily due to common clinical practice.
Drug: Capecitabine
Two dosages comparison
Other Name: Xeloda




Primary Outcome Measures :
  1. Progress Free Survival (PFS) [ Time Frame: 24 month ]
    The primary endpoint of this study is PFS, defined as the time from treatment start to progression or last date of follow-up. PFS will be estimated using Kaplan-Meier methods. This will be an intention to treat analysis. The Log-rank test will be used to test whether PFS is different for the two capecitabine schedules. It is hypothesized that the 7-7 schedule of capecitabine will have superior efficacy.


Secondary Outcome Measures :
  1. Number of participants with toxicity. [ Time Frame: 24 month ]

    Secondary Objectives:

    • To assess and compare tolerability of the two capecitabine schedules in terms of selected hematologic and non-hematologic toxicities.
    • To compare the rates of grade 3 or greater diarrhea, nausea and vomiting between the two schedules.

  2. Number of patients with treatment delays. [ Time Frame: 24 month ]
  3. Number of patients with dose reduction. [ Time Frame: 24 month ]
  4. Number of patients with study withdrawal. [ Time Frame: 24 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1 Subject Inclusion Criteria

    • Informed consent has been obtained.
    • Metastatic breast cancer.
    • Measurable or non-measurable disease per RECIST criteria.
    • Pathologic confirmation of breast cancer.
    • No limit to the number of prior chemotherapy regimens permitted for metastatic disease.
    • At least 3 weeks since prior chemotherapy. Patients should have recovered from all acute toxicity from such therapy (excluding alopecia).
    • Age ≥18.
    • ECOG 0-2
    • Absolute Neutrophil Count (ANC )≥1.0; hemoglobin ≥9, platelets

      ≥75.000

    • AST, ALT and Alkaline phosphatase <2.5x upper limit of normal (or <5x upper limit of normal in the case of liver metastases). Total bilirubin <1.5x upper limit of normal.
    • Estimated creatinine clearance >50ml/min.
    • If female of childbearing potential, pregnancy test is negative and the patient agrees to use an effective method to avoid pregnancy during the study.

Exclusion Criteria:

  • HER2 over-expression and/or amplification as determined by immunohistochemistry (3+) or FISH (>2.0).

    • No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if >12 months have elapsed since treatment.
    • No restriction for prior hormonal therapy.
    • GI malabsorption syndrome which could impair oral drug absorption.
    • Concurrent use of warfarin is discouraged as drug interactions may make management of INR more difficult.
    • Central nervous system metastases are permitted if previously treated or clinically stable for at least 3 months.
    • Pregnant or nursing patients.
    • Life expectancy <3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028494


Contacts
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Contact: Daniel Campos, MD +5491144204242 dcampos@slacom.org

Locations
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Argentina
SLACOM Recruiting
Buenos Aires, Argentina, 1120
Sponsors and Collaborators
Latin American & Caribbean Society of Medical Oncology
Breast Cancer Research Foundation
Investigators
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Study Chair: Eduardo Cazap, MD,PhD Latin American & Caribbean Society of Medical Oncology
Study Chair: Tiffany Traina, MD MSKCC
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Responsible Party: Latin American & Caribbean Society of Medical Oncology
ClinicalTrials.gov Identifier: NCT02028494    
Other Study ID Numbers: SLACOM Cap 7/7
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents