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

NCT ID: NCT02028494

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2019-03-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 ).

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Two dosages comparison

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.

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Two dosages comparison

Interventions

Capecitabine

Two dosages comparison

Intervention Type: DRUG

Other Intervention Names

Xeloda

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

Latin American & Caribbean Society of Medical Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Cazap, MD,PhD

Role: STUDY_CHAIR

Latin American & Caribbean Society of Medical Oncology

Tiffany Traina, MD

Role: STUDY_CHAIR

MSKCC

Locations

SLACOM

Buenos Aires, , Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Daniel Campos, MD

Role: CONTACT

dcampos@slacom.org

+5491144204242

Other Identifiers

SLACOM Cap 7/7

Identifier Type: -

Identifier Source: org_study_id