Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
NCT06105684 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-01-07
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
Interventions
- DRUG
-
Capecitabine Pill
Will be given once per day by mouth
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Humaria Sarfraz, MD · The University of Alabama at Birmingham
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-14
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Management of Metastatic Breast Cancer in Frail Patients
NCT00005614 ·Status: WITHDRAWN ·Phase: PHASE2
-
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer
NCT00347438 ·Status: TERMINATED ·Phase: PHASE2
-
Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
NCT00070252 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer
NCT00684216 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer
NCT00609791 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Capecitabine in Women With Operable Breast Cancer
NCT00148720 ·Status: TERMINATED ·Phase: PHASE2
-
Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
NCT00153907 ·Status: COMPLETED ·Phase: PHASE1
-
BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
NCT00540800 ·Status: COMPLETED ·Phase: PHASE3
-
Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer
NCT05064085 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer
NCT02664103 ·Status: COMPLETED ·Phase: PHASE2
-
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer
NCT00034918 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer
NCT02115152 ·Status: UNKNOWN ·Phase: PHASE2
-
Sorafenib in Treating Patients With Metastatic Breast Cancer
NCT00096434 ·Status: COMPLETED ·Phase: PHASE2
-
Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
NCT00005817 ·Status: COMPLETED ·Phase: PHASE2
-
Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
NCT00025688 ·Status: UNKNOWN ·Phase: PHASE3
-
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
NCT03286842 ·Status: COMPLETED ·Phase: PHASE3
-
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
NCT03204734 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
NCT06247995 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
NCT06525766 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
NCT00821054 ·Status: COMPLETED ·Phase: PHASE1
-
S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
NCT00107276 ·Status: COMPLETED ·Phase: PHASE2
-
Docetaxel and Carboplatin in Treating Women With Metastatic Breast Cancer
NCT00005963 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Trial of Capecitabine With Fulvestrant for Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer
NCT00534417 ·Status: COMPLETED ·Phase: PHASE2
-
Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
NCT00031876 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer
NCT02028494 ·Status: UNKNOWN ·Phase: NA