Clinical Trials /

Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer

NCT03958721

Description:

This is a single-arm, prospective, non-randomized, feasibility study evaluating concurrent capecitabine-radiotherapy in participants with Resistant Breast Cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer
  • Official Title: Concurrent Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer: A Prospective Feasibility Trial

Clinical Trial IDs

  • ORG STUDY ID: VICC BREP 1898
  • SECONDARY ID: NCI-2019-03276
  • NCT ID: NCT03958721

Conditions

  • Resistant Breast Cancer
  • Non-metastatic Invasive Breast Cancer

Interventions

DrugSynonymsArms
CapecitabineConcurrent Adjuvant Capecitabine and Radiotherapy

Purpose

This is a single-arm, prospective, non-randomized, feasibility study evaluating concurrent capecitabine-radiotherapy in participants with Resistant Breast Cancer.

Detailed Description

      Primary Objective:

      - To evaluate the feasibility of a novel concurrent capecitabine-radiotherapy regimen by
      characterizing the percentage of patients who complete concurrent capecitabine-radiotherapy
      as a preliminary study before a larger trial.

      Secondary Objectives

        -  To report the tolerability of concurrent capecitabine-radiotherapy with patient-reported
           HRQOL outcomes via RAND 36-Item Health Survey.

        -  To characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy
           through patient-reported RISR scores and to compare concurrent RISR scores to published
           reports of patients undergoing breast cancer radiotherapy only.

        -  To provide a preliminary description of the toxicity profile of concurrent capecitabine
           radiotherapy and report the frequency of grade 3 or grade 4 toxicity during combined
           therapy.

        -  To report the feasibility of completion of all study assessments, and completion of all
           study and exploratory assessments.

      Outline:

      This trial will investigate chemoradiotherapy with capecitabine at 1000 mg/m2 BID every other
      week during radiotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
Concurrent Adjuvant Capecitabine and RadiotherapyExperimental
  • Capecitabine

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with histologically confirmed non-metastatic invasive breast cancer who will
             be undergoing neoadjuvant chemotherapy and have persistent disease at time of
             definitive surgery

               -  Tumors must have ER/PR/HER2 status reported by available pathology report(s)

               -  Both triple negative and hormone receptor positive patients are eligible for
                  enrollment

          -  Completion of neoadjuvant chemotherapy

               -  May not include capecitabine or 5-FU containing regimens

               -  Resolution of adverse events from neoadjuvant chemotherapy including
                  biochemical/hematologic to CTCAE v5.0 grade 1 or below (except alopecia) prior to
                  initiation of study therapy

               -  Recovery time between surgery and study therapy ≥ 4 weeks.

          -  Persistent invasive disease following neoadjuvant chemotherapy in either the breast,
             lymph node, or both ). Any residual tumor; lack of complete pathologic response.

          -  Patients planning to receive adjuvant radiation to the breast and/or regional nodes.

          -  Patients planning to receive capecitabine per the treating physician

        Patients already receiving capecitabine as adjuvant therapy are eligible to enroll in this
        study, provided adverse events deemed by the treating physician as possibly, probably or
        definitely related to adjuvant capecitabine prior to study therapy have resolved to CTCAE
        v.5.0 grade 1 or below (except alopecia), and provided duration of planned capecitabine
        includes entire duration of planned radiotherapy.

          -  ECOG performance status 0 or 1

          -  Tamoxifen: patients who have received Tamoxifen as chemoprevention are still eligible.

        Endocrine receptor therapies (Hormone receptor inhibitors) may not be given with study
        treatment.

          -  . Patients who have had radiation to the contralateral breast are eligible.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Pregnant or lactating females. Women who are pregnant or who become pregnant are
             excluded from this study because capecitabine is a chemotherapeutic agent with the
             potential for teratogenic or abortifacient effects. Because there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with capecitabine, breastfeeding should be discontinued if the mother is
             treated with capecitabine. These potential risks may also apply to radiotherapy used
             in this study.

          -  Serious medical or psychiatric illness that in the judgement of the treating physician
             places the patient at risk & would limit compliance with the study requirements.

          -  Inability to swallow or retain whole pills.

          -  Patients with known or suspected allergy to capecitabine or 5-FU.

          -  Contraindications to capecitabine or radiotherapy as determined by the treating
             physician including severe renal impairment (GFR < 30).

          -  Prior radiation to the ipsilateral breast.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of patients who complete concurrent capecitabine-radiotherapy
Time Frame:Up to 6 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Assess tolerability
Time Frame:Up to 6 months
Safety Issue:
Description:Patient reported health-related quality of life outcomes via RAND 36-Item Health Survey HRQOL outcomes via RAND 36-Item Health Survey
Measure:Characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy
Time Frame:Up to 7 months
Safety Issue:
Description:Through patient-reported RISR scores
Measure:Frequency of grade 3-4 adverse events
Time Frame:Up to 7 months
Safety Issue:
Description:Events will be graded according to the National Cancer Institute Common Terminology
Measure:Completion of study study assessments
Time Frame:Up to 7 months
Safety Issue:
Description:Median number of study assessments completed
Measure:Completion of exploratory assessments
Time Frame:Up to 7 months
Safety Issue:
Description:Median number of exploratory assessment completed

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:A Bapsi Chakravarthy, MD

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