- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06105684
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Pamela M Hardwick
- Phone Number: 205-975-5387
- Email: pamdixon@uab.edu
Study Contact Backup
- Name: Katia Khoury, MD
- Phone Number: 205-975-2477
- Email: kkhoury@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
Principal Investigator:
- Katia Khoury, MD
-
Contact:
- Katia Khoury, MD
- Phone Number: 205-975-2477
- Email: kkhoury@uabmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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)
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.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose capecitabine (Xeloda)
1000 mg capecitabine daily by mouth.
|
Will be given once per day by mouth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Up to 36 months
|
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.
|
Up to 36 months
|
Overall survival (OS)
Time Frame: Baseline up to 36 months
|
The time which begins at diagnosis (or at the start of treatment) and up to the time of death.
|
Baseline up to 36 months
|
Number of adverse events
Time Frame: Baseline up to 36 months
|
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.
|
Baseline up to 36 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300012026
- UAB23115 (Other Identifier: UAB Cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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