RECRUITING

Phase II Single Arm Trial of Low Dose Capecitabine in Patients with Advanced Breast Cancer

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Single Arm Trial of Low Dose Capecitabine in Patients with Advanced Breast Cancer

Quick Facts

Study Start:2025-02-14

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06105684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enrollment. 1. HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+. 2. Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment. 2. Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1). 3. ECOG performance status of 0-2. 4. Patients must have progressed on at least 1 prior line of therapy in the metastatic setting (hormonal therapy or chemotherapy) 5. Adequate organ function as evidenced by: 1. ANC \>1.5 x 10⁹/L (1500/µL) or \> 1.3 x 10⁹/L (1300/µL) for patients with history of benign ethnic neutropenia. 2. Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to initiation of study treatment (Cycle 1, day 1)). 3. Hemoglobin ≥9.0 g/dl. Patients may be transfused or receive erythropoietic treatment to meet this criterion. 4. 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 5. Serum bilirubin ≤1.5 x ULN 6. INR and aPTT ≤1.5 x ULN 7. Creatinine clearance \> 30 mL/min (measured using Cockcroft-Gault equation or estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study) 6. Patients must be able to provide signed informed consent. 7. 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). 8. 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. 9. Complete initial work-up within 2 weeks prior to start of treatment (Cycle 1 Day 1). 10. Patients known to be HIV positive are eligible if they meet the inclusion criteria.	1. Any history of treatment with Capecitabine in metastatic setting. 2. Patients who only have non-measurable disease. 3. Patients with severe hepatic (bilirubin \> 3 times upper limit of normal) or renal failure (CrCl \< 30 calculated using Cockcroft-Gault formula). 4. Patients who are unable to swallow pills 5. Patients with HER2 positive breast cancer 6. Major surgical procedure within 3 weeks prior to study entry. 7. 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)

Inclusion Criteria

Exclusion Criteria

1. Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enrollment.
1. HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+.
2. Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment.
2. Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).
3. ECOG performance status of 0-2.
4. Patients must have progressed on at least 1 prior line of therapy in the metastatic setting (hormonal therapy or chemotherapy)
5. Adequate organ function as evidenced by:
1. ANC \>1.5 x 10⁹/L (1500/µL) or \> 1.3 x 10⁹/L (1300/µL) for patients with history of benign ethnic neutropenia.
2. Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to initiation of study treatment (Cycle 1, day 1)).
3. Hemoglobin ≥9.0 g/dl. Patients may be transfused or receive erythropoietic treatment to meet this criterion.
4. 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
5. Serum bilirubin ≤1.5 x ULN
6. INR and aPTT ≤1.5 x ULN
7. Creatinine clearance \> 30 mL/min (measured using Cockcroft-Gault equation or estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study)
6. Patients must be able to provide signed informed consent.
7. 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).
8. 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.
9. Complete initial work-up within 2 weeks prior to start of treatment (Cycle 1 Day 1).
10. Patients known to be HIV positive are eligible if they meet the inclusion criteria.

1. Any history of treatment with Capecitabine in metastatic setting.
2. Patients who only have non-measurable disease.
3. Patients with severe hepatic (bilirubin \> 3 times upper limit of normal) or renal failure (CrCl \< 30 calculated using Cockcroft-Gault formula).
4. Patients who are unable to swallow pills
5. Patients with HER2 positive breast cancer
6. Major surgical procedure within 3 weeks prior to study entry.
7. 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)

Contacts and Locations

Study Contact

Pamela M Hardwick

CONTACT

205-975-5387

pamdixon@uab.edu

Margaret Thomas, MPH

CONTACT

margaretannthomas@uabmc.edu

Principal Investigator

Katia Khoury, MD

PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Katia Khoury, MD, PRINCIPAL_INVESTIGATOR, The University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-14

Study Completion Date2028-06

Study Record Updates

Study Start Date2025-02-14

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Breast Cancer