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Capecitabine and Radiation Therapy after Surgery in Treating Patients with Non-Metastatic Invasive Breast cancer

Trial Status: Active

This phase I trial studies how well capecitabine and radiation therapy after surgery work in treating patients with invasive breast cancer that has not spread to other places in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving capecitabine and radiation therapy together may kill more tumor cells in patients with invasive breast cancer compared to capecitabine or radiation therapy alone.

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 estrogen receptor (ER)/progesterone receptor (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 fluorouracil (5-FU) containing regimens * Resolution of adverse events from neoadjuvant chemotherapy including biochemical/hematologic to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patients who have received tamoxifen as chemoprevention are still eligible. A minimum 4-week washout period before study treatment is required. 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 (glomerular filtration rate [GFR] < 30)
  • Prior radiation to the ipsilateral breast

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Anuradha Bapsi Chakravarthy
Phone: 615-322-2555

PRIMARY OBJECTIVE:

I. 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:

I. To report the tolerability of concurrent capecitabine-radiotherapy with patient-reported health-related quality of life (HRQOL) outcomes via research and development (RAND) 36-Item Health Survey.

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

III. To provide a preliminary description of the toxicity profile of concurrent capecitabine-radiotherapy and report the frequency of g3 or g4 toxicity during combined therapy.

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

EXPLORATORY CORRELATIVE STUDY OBJECTIVES:

I. To pilot a novel methodology of quantifying radiation dermatitis as a continuous variable termed “erythema index”.

II. To explore the clinical utility of the erythema index and correlations with clinician-driven determinations of radiation dermatitis and patient-reported outcomes of radiation dermatitis.

III. To report on inter-user variations in body-surface-area deemed affected by dermatitis.

OUTLINE:

Patients receive capecitabine orally (PO) twice daily (BID) every other week and undergo radiation therapy once daily (QD) on Monday-Friday for 6 weeks. After completion of radiation therapy, patients may continue to receive capecitabine PO BID every other week or on days 1-14 at the discretion of the treating physician. Cycles repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks, then at 1 and 2 years.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Vanderbilt University / Ingram Cancer Center

Principal Investigator
Anuradha Bapsi Chakravarthy

  • Primary ID VICC BREP 1898
  • Secondary IDs NCI-2019-03276
  • Clinicaltrials.gov ID NCT03958721