Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer

• ClinicalTrials.gov Identifier: NCT03958721
• Recruitment Status: Recruiting
• First Posted: May 22, 2019
• Last Update Posted: June 7, 2021
• Sponsor: A Bapsi Chakravarthy, MD
• Information provided by (Responsible Party): A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Resistant Breast Cancer; Non-metastatic Invasive Breast Cancer	Drug: Capecitabine; Radiation: Radiotherapy	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Concurrent Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer: A Prospective Feasibility Trial
• Actual Study Start Date: July 18, 2019
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Concurrent Adjuvant Capecitabine and Radiotherapy	Drug: Capecitabine; 1,000 mg/m2 twice daily taken by mouth every other week; Radiation: Radiotherapy; Once daily (Monday through Friday) for six weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage of patients who complete concurrent capecitabine-radiotherapy [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Vanderbilt-Ingram Service Information Program; 800-811-8480; cip@vumc.org

Locations

United States, Tennessee

Vanderbilt-Ingram Cancer Center; Recruiting

Nashville, Tennessee, United States, 37232

Contact: Vanderbilt-Ingram Service Information Program 800-811-8480 cip@vumc.org

Principal Investigator: Bapsi Chakravarthy, MD

Sponsors and Collaborators

A Bapsi Chakravarthy, MD

Investigators

• Principal Investigator: Bapsi Chakravarthy, MD; Vanderbilt Medical Center

More Information

• Responsible Party: A Bapsi Chakravarthy, MD, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT03958721
• Other Study ID Numbers: VICC BREP 1898; NCI-2019-03276 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
• First Posted: May 22, 2019
• Last Update Posted: June 7, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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.: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Capecitabine; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents