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Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer

Primary Purpose

Resistant Breast Cancer, Non-metastatic Invasive Breast Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Capecitabine

Radiotherapy

About this trial

This is an interventional treatment trial for Resistant Breast Cancer

Eligibility Criteria

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

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.

Sites / Locations

Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concurrent Adjuvant Capecitabine and Radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients who complete concurrent capecitabine-radiotherapy

Secondary Outcome Measures

Assess tolerability

Patient reported health-related quality of life outcomes via RAND 36-Item Health Survey HRQOL outcomes via RAND 36-Item Health Survey

Characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy

Through patient-reported RISR scores

Frequency of grade 3-4 adverse events

Events will be graded according to the National Cancer Institute Common Terminology

Completion of study study assessments

Median number of study assessments completed

Completion of exploratory assessments

Median number of exploratory assessment completed

Full Information

NCT ID

NCT03958721

First Posted

May 17, 2019

Last Updated

February 16, 2023

Sponsor

A Bapsi Chakravarthy, MD

1. Study Identification

Unique Protocol Identification Number

NCT03958721

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 18, 2019 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

A Bapsi Chakravarthy, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Resistant Breast Cancer, Non-metastatic Invasive Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Concurrent Adjuvant Capecitabine and Radiotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

1,000 mg/m2 twice daily taken by mouth every other week

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Once daily (Monday through Friday) for six weeks

Primary Outcome Measure Information:

Title

Percentage of patients who complete concurrent capecitabine-radiotherapy

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Assess tolerability

Description

Patient reported health-related quality of life outcomes via RAND 36-Item Health Survey HRQOL outcomes via RAND 36-Item Health Survey

Time Frame

Up to 6 months

Title

Characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy

Description

Through patient-reported RISR scores

Time Frame

Up to 7 months

Title

Frequency of grade 3-4 adverse events

Description

Events will be graded according to the National Cancer Institute Common Terminology

Time Frame

Up to 7 months

Title

Completion of study study assessments

Description

Median number of study assessments completed

Time Frame

Up to 7 months

Title

Completion of exploratory assessments

Description

Median number of exploratory assessment completed

Time Frame

Up to 7 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bapsi Chakravarthy, MD

Organizational Affiliation

Vanderbilt Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer

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