Metastatic Breast CancerPhase 2NCT06105684
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
A Phase 2 study testing Capecitabine Pill in people with Metastatic Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Capecitabine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enrollment.
- HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+.
- Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment.
- Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).
- ECOG performance status of 0-2.
- Patients must have progressed on at least 1 prior line of therapy in the metastatic setting (hormonal therapy or chemotherapy)
Show all 21Show fewer
- Adequate organ function as evidenced by:
- ANC >1.5 x 10⁹/L (1500/µL) or > 1.3 x 10⁹/L (1300/µL) for patients with history of benign ethnic neutropenia.
- Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to initiation of study treatment (Cycle 1, day 1)).
- Hemoglobin ≥9.0 g/dl. Patients may be transfused or receive erythropoietic treatment to meet this criterion.
- AST, ALT, and alkaline phosphatase ≤2.5 x upper limit of normal (ULN) with following exceptions: I. Patients with documented liver metastasis: AST and ALT ≤5 x ULN II. Patients with documented liver or bone metastasis: alkaline phosphatase ≤5 x ULN
- Serum bilirubin ≤1.5 x ULN
- Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled.
- INR and aPTT ≤1.5 x ULN
- This applies only to the patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- Creatinine clearance > 30 mL/min (measured using Cockcroft-Gault equation or estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study)
- Patients must be able to provide signed informed consent.
- Female patients of any ethnic group. Female patients must be surgically sterile, postmenopausal (no menses for at least one year), or using medically approved method of contraception (excluding rhythm, withdraw or abstinence). Men must agree to use a medically approved method of contraception (excluding rhythm, withdraw or abstinence).
- Patients ≥60 years old and/or frail patients at any age, defined by the investigator as an individual at greater risk of complications and poorer outcomes with systemic therapy, secondary to a lower physiologic reserve and higher comorbidities and functional deficits.
- Complete initial work-up within 2 weeks prior to start of treatment (Cycle 1 Day 1).
- Patients known to be HIV positive are eligible if they meet the inclusion criteria.
Who cannot join
- Any history of treatment with Capecitabine in metastatic setting.
- Patients who only have non-measurable disease.
- Patients with severe hepatic (bilirubin > 3 times upper limit of normal) or renal failure (CrCl < 30 calculated using Cockcroft-Gault formula).
- Patients who are unable to swallow pills
- Patients with HER2 positive breast cancer
- Major surgical procedure within 3 weeks prior to study entry.
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >2 weeks prior to initiation of study treatment (Cycle 1, Day 1)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Humaria Sarfraz, MD, 205-975-2891, humairasarfraz@uabmc.edu
Katia Khoury, MD
About this study
This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
Read the detailed description
The study is a phase II, single arm study in which all patients will receive the study drug. Participants will include older/frail patients with metastatic breast cancer.
All patients will be treated with capecitabine 1000 mg daily. There will be a total of 40 participants with measurable disease on this trial.
The study will encompass participants with locally advanced unresectable/metastatic breast cancer with measurable disease, who progressed on at least 1 prior therapy in the metastatic setting. Breast cancer subtypes include HR+ HER2 negative, or TNBC, age ≥ 60 years old, or frail patients at a younger age. ECOG PS 0- 2.
The study will discontinue if progressive disease or unacceptable toxicity is noted.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Capecitabine Pill
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine PillDrug
Also called Xeloda
Will be given once per day by mouth
| Study group | Role | What they receive |
|---|---|---|
| Low dose capecitabine (Xeloda) | Experimental | 1000 mg capecitabine daily by mouth. Receives: Drug: Capecitabine Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (RR) evaluation
Evaluate response rate (RR) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v 1.1). Response and progression of disease will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee; version 1.1. Patients will be evaluated for response every 12 weeks per RECIST Criteria.
Measured: Baseline up to 12 weeks
Secondary outcomes (3)
Progression-free survival (PFS)
Initiation of treatment to the occurrence of disease progression or death. The RECIST v. 1.1 criteria will be used to evaluate progression-free survival as well as CT and PET scans. Baseline to the date of first documented progression to date of death from any cause, whichever comes first, assessed up to 36 months.
Measured: Up to 36 months
Overall survival (OS)
The time which begins at diagnosis (or at the start of treatment) and up to the time of death.
Measured: Baseline up to 36 months
Number of adverse events
Incidence of Treatment-Emergent Adverse Events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Safety, tolerability, satisfaction, and quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) questionnaire, as well as the PRO-CTCAE (Patient reported outcomes - Common Terminology Criteria for Adverse Events) questionnaire.
Measured: Baseline up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start14 Feb 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humaria Sarfraz, University of Alabama at Birmingham
- Investigators
- Humaria Sarfraz, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105684
- Sponsor's protocol ID
- IRB-300012026 (UAB23115)
- Other IDs
- Robert Award, Breast Cancer Foundation
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06105684
- Acronym / sponsor ID
- IRB-300012026 (UAB23115)
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Oct 2023 (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 phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
Detailed description
The study is a phase II, single arm study in which all patients will receive the study drug. Participants will include older/frail patients with metastatic breast cancer.
All patients will be treated with capecitabine 1000 mg daily. There will be a total of 40 participants with measurable disease on this trial.
The study will encompass participants with locally advanced unresectable/metastatic breast cancer with measurable disease, who progressed on at least 1 prior therapy in the metastatic setting. Breast cancer subtypes include HR+ HER2 negative, or TNBC, age ≥ 60 years old, or frail patients at a younger age. ECOG PS 0- 2.
The study will discontinue if progressive disease or unacceptable toxicity is noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose capecitabine (Xeloda) | Experimental | Drug: Capecitabine Pill1000 mg capecitabine daily by mouth. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enrollment.
- Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).
- ECOG performance status of 0-2.
- Patients must have progressed on at least 1 prior line of therapy in the metastatic setting (hormonal therapy or chemotherapy)
- Adequate organ function as evidenced by:
Key exclusion criteria (7 listed)
- Any history of treatment with Capecitabine in metastatic setting.
- Patients who only have non-measurable disease.
- Patients with severe hepatic (bilirubin > 3 times upper limit of normal) or renal failure (CrCl < 30 calculated using Cockcroft-Gault formula).
- Patients who are unable to swallow pills
- Patients with HER2 positive breast cancer
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 |
|---|---|---|
| Capecitabine PillAlso: XelodaWill be given once per day by mouth | Drug | Low dose capecitabine (Xeloda) |
Primary outcome
Objective response rate (RR) evaluation
Time frame: Baseline up to 12 weeks
Evaluate response rate (RR) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v 1.1). Response and progression of disease will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee; version 1.1. Patients will be evaluated for response every 12 weeks per RECIST Criteria.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 36 months
Overall survival (OS)
Time frame: Baseline up to 36 months
Number of adverse events
Time frame: Baseline up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Humaria Sarfraz, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine Pill in people with Metastatic Breast Cancer, run by University of Alabama at Birmingham 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 21 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret Thomas, MPH (205-895-1802, margaretathomas@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (RR) evaluation (time frame: Baseline up to 12 weeks). 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 30 Sep 2026.