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

Latin American & Caribbean Society of Medical Oncology

Status: Unknown

Conditions: Breast Cancer

Treatments: Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02028494

SLACOM Cap 7/7

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

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

Experimental group

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 ).

Treatment:

Drug: Capecitabine

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

Active Comparator group

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.

Treatment:

Drug: Capecitabine