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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06105684
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
56
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Capecitabine Pill
 Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Anticipated Study Start Date :
Apr 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low dose capecitabine (Xeloda)

1000 mg capecitabine daily by mouth.

Drug: Capecitabine Pill
Will be given once per day by mouth
Other Names:
  • Xeloda

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rate (RR) evaluation [12 weeks]

      Evaluate response rate (RR) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v 1.1). Response and progression 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.

    Secondary Outcome Measures

    1. Progression-free survival (PFS) [Up to 36 months]

      Initiation of treatment to the occurrence of disease progression or death.

    2. Overall survival (OS) [Up to 36 months]

      The time which begins at diagnosis (or at the start of treatment) and up to the time of death.

    3. Safety and tolerability [Up to 36 months]

      Patient will be treated with study drug until disease progression, unacceptable toxicity, or discontinuation of study treatment. Capecitabine treatment may be temporarily suspended in patients experiencing Grade 3-4 toxicity considered to be related to study treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion 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.

    2. HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+.

    3. Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment.

    4. Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).

    5. ECOG performance status of 0-2.

    6. Patients must have progressed on at least 1 prior line of therapy in the metastatic setting (hormonal therapy or chemotherapy)

    7. Adequate organ function as evidenced by:

    8. ANC >1.5 x 10⁹/L (1500/µL) or > 1.3 x 10⁹/L (1300/µL) for patients with history of benign ethnic neutropenia.

    9. Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to initiation of study treatment (Cycle 1, day 1)).

    10. Hemoglobin ≥9.0 g/dl. Patients may be transfused or receive erythropoietic treatment to meet this criterion.

    11. 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

    12. Serum bilirubin ≤1.5 x ULN

    • Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled.

    1. 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.

    1. Creatinine clearance > 30 mL/min (measured using Cockcroft-Gault equation or estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study)

    2. Patients must be able to provide signed informed consent.

    3. 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).

    4. 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.

    5. Complete initial work-up within 2 weeks prior to start of treatment (Cycle 1 Day 1).

    6. Patients known to be HIV positive are eligible if they meet the inclusion criteria.

    Exclusion 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

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katia Khoury, MD, Assistant Professor, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT06105684
    Other Study ID Numbers:
    • IRB-300012026
    • UAB23115
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Capecitabine

    Study Results

    No Results Posted as of Oct 30, 2023