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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Not Available
Phase I
Adults
Not Available
Not Available
Chak, Bapsi
Local
Vanderbilt University
07-18-2019
Treatment
VICCBREP1898
NCT03958721

Eligibility

18 Years
FEMALE
NO
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]
Prior radiation to the ipsilateral breast

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