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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
Latin American & Caribbean Society of Medical Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • SLACOMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Capecitabine 2,000 mg (flat dose)

Arm B: Capecitabine 1,000 mg/m2 twice daily for 14 day

Arm Description

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 ).

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.

Outcomes

Primary Outcome Measures

Progress Free Survival (PFS)
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

Number of participants with toxicity.
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.
Number of patients with treatment delays.
Number of patients with dose reduction.
Number of patients with study withdrawal.

Full Information

First Posted
January 3, 2014
Last Updated
September 6, 2018
Sponsor
Latin American & Caribbean Society of Medical Oncology
Collaborators
Breast Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02028494
Brief Title
Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer
Acronym
CAP7/7
Official Title
Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Latin American & Caribbean Society of Medical Oncology
Collaborators
Breast Cancer Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Capecitabine 2,000 mg (flat dose)
Arm Type
Experimental
Arm Description
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 ).
Arm Title
Arm B: Capecitabine 1,000 mg/m2 twice daily for 14 day
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Two dosages comparison
Primary Outcome Measure Information:
Title
Progress Free Survival (PFS)
Description
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.
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Number of participants with toxicity.
Description
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.
Time Frame
24 month
Title
Number of patients with treatment delays.
Time Frame
24 month
Title
Number of patients with dose reduction.
Time Frame
24 month
Title
Number of patients with study withdrawal.
Time Frame
24 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Campos, MD
Phone
+5491144204242
Email
dcampos@slacom.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Cazap, MD,PhD
Organizational Affiliation
Latin American & Caribbean Society of Medical Oncology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tiffany Traina, MD
Organizational Affiliation
MSKCC
Official's Role
Study Chair
Facility Information:
Facility Name
SLACOM
City
Buenos Aires
ZIP/Postal Code
1120
Country
Argentina
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer

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