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

NCT06105684 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB-300012026 (UAB23115)Robert AwardBreast Cancer Foundation
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to 12 weeks

Secondary Outcomes (3)

• Progression-free survival (PFS)

  Up to 36 months

• Overall survival (OS)

  Baseline up to 36 months

• Number of adverse events

  Baseline up to 36 months

Study Arms (1)

Low dose capecitabine (Xeloda)

EXPERIMENTAL

1000 mg capecitabine daily by mouth.

Drug: Capecitabine Pill

Interventions

Capecitabine Pill DRUG

Will be given once per day by mouth

Also known as: Xeloda

Low dose capecitabine (Xeloda)

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Humaria Sarfraz, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Thomas, MPH

CONTACT

205-895-1802; margaretathomas@uabmc.edu

Katia Khouri, MD

CONTACT

216-556-3035; katia.khoury@gunet.georgetown.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: February 14, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)