Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer

NCT03958721 | Completed Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: VICC BREP 1898NCI-2019-03276
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Resistant Breast Cancer; Non-metastatic Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who complete concurrent capecitabine-radiotherapy

  Up to 6 months

Secondary Outcomes (5)

• Assess tolerability

  Up to 6 months

• Characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy

  Up to 7 months

• Frequency of grade 3-4 adverse events

  Up to 7 months

• Completion of study study assessments

  Up to 7 months

• Completion of exploratory assessments

  Up to 7 months

Study Arms (1)

Concurrent Adjuvant Capecitabine and Radiotherapy

EXPERIMENTAL

Drug: Capecitabine; Radiation: Radiotherapy

Interventions

Capecitabine DRUG

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

Concurrent Adjuvant Capecitabine and Radiotherapy

Radiotherapy RADIATION

Once daily (Monday through Friday) for six weeks

Concurrent Adjuvant Capecitabine and Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• A Bapsi Chakravarthy, MD: lead

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Capecitabine; Radiotherapy

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Study Officials

• Bapsi Chakravarthy, MD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor; Radiation Oncology

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 22, 2019
• Study Start: July 18, 2019
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)