Resistant Breast CancerPhase 1NCT03958721
Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer
A Phase 1 study testing Capecitabine and Radiotherapy in people with Resistant Breast Cancer and Non-metastatic Invasive Breast Cancer, run by A Bapsi Chakravarthy, MD at 1 site in United States.
Trial summary
This is a single-arm, prospective, non-randomized, feasibility study evaluating concurrent capecitabine-radiotherapy in participants with Resistant Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Resistant Breast Cancer, Non-metastatic Invasive Breast Cancer
- What is being tested?
- Capecitabine and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2019to 26 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Concurrent Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer: A Prospective Feasibility Trial
This is a single-arm, prospective, non-randomized, feasibility study evaluating concurrent capecitabine-radiotherapy in participants with Resistant Breast Cancer.
Read the 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.
- Being tested
- Capecitabine, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
1,000 mg/m2 twice daily taken by mouth every other week
RadiotherapyRadiation
Once daily (Monday through Friday) for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Adjuvant Capecitabine and Radiotherapy | Experimental | Not described Receives: Drug: Capecitabine; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who complete concurrent capecitabine-radiotherapy
Measured: Up to 6 months
Secondary outcomes (5)
Assess tolerability
Patient reported health-related quality of life outcomes via RAND 36-Item Health Survey HRQOL outcomes via RAND 36-Item Health Survey
Measured: Up to 6 months
Characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy
Through patient-reported RISR scores
Measured: Up to 7 months
Frequency of grade 3-4 adverse events
Events will be graded according to the National Cancer Institute Common Terminology
Measured: Up to 7 months
Completion of study study assessments
Median number of study assessments completed
Measured: Up to 7 months
Completion of exploratory assessments
Median number of exploratory assessment completed
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start18 Jul 2019
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- A Bapsi Chakravarthy, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Bapsi Chakravarthy, MD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958721
- Sponsor's protocol ID
- VICC BREP 1898
- Other IDs
- NCI-2019-03276
- Status last verified
- Nov 2023
- First submitted
- 17 May 2019
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Capecitabine and Radiotherapy in the Adjuvant Treatment of Resistant Breast Cancer: A Prospective Feasibility Trial
- ClinicalTrials.gov ID
- NCT03958721
- Acronym / sponsor ID
- VICC BREP 1898
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- A Bapsi Chakravarthy, MDUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent Adjuvant Capecitabine and Radiotherapy | Experimental | Drug: Capecitabine, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with histologically confirmed non-metastatic invasive breast cancer who will be undergoing neoadjuvant chemotherapy and have persistent disease at time of definitive surgery
- Completion of neoadjuvant chemotherapy
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine1,000 mg/m2 twice daily taken by mouth every other week | Drug | Concurrent Adjuvant Capecitabine and Radiotherapy |
| RadiotherapyOnce daily (Monday through Friday) for six weeks | Radiation | Concurrent Adjuvant Capecitabine and Radiotherapy |
Primary outcome
Percentage of patients who complete concurrent capecitabine-radiotherapy
Time frame: Up to 6 months
5 secondary outcomes
Assess tolerability
Time frame: Up to 6 months
Characterize radiation dermatitis secondary to concurrent capecitabine-radiotherapy
Time frame: Up to 7 months
Frequency of grade 3-4 adverse events
Time frame: Up to 7 months
Completion of study study assessments
Time frame: Up to 7 months
Completion of exploratory assessments
Time frame: Up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bapsi Chakravarthy, MD principal investigator
Vanderbilt Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capecitabine and Radiotherapy in people with Resistant Breast Cancer and Non-metastatic Invasive Breast Cancer, run by A Bapsi Chakravarthy, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who complete concurrent capecitabine-radiotherapy (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.