Description:
This is a single-arm, prospective, non-randomized, feasibility study evaluating concurrent
capecitabine-radiotherapy in participants with Resistant Breast Cancer.
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
Drug | Synonyms | Arms |
---|
Capecitabine | | Concurrent 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
Name | Type | Description | Interventions |
---|
Concurrent Adjuvant Capecitabine and Radiotherapy | Experimental | | |
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: | Recruiting |
Lead Sponsor: | A Bapsi Chakravarthy, MD |
Last Updated
June 7, 2021