RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a low dose of capecitabine, a cancer medicine, taken at 1,000 mg once a day for advanced breast cancer. It is for people age 60 or older, or people of any age who are frail and have a higher risk of problems with other treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have breast cancer confirmed by a tissue or cell test that is HER2-negative, meaning it does not have high levels of the HER2 protein. Hormone receptor-positive and triple-negative cancers are allowed.
  • Have cancer that has spread to other parts of the body or nearby areas, with at least one tumor that can be measured.
  • Be age 60 or older, or be judged frail by the study doctor because of other health problems, limited strength, or trouble with daily tasks.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Have cancer that got worse after at least one hormone treatment or chemotherapy treatment for cancer that had spread.
  • Meet the study's blood count, liver, kidney, and blood-clotting test requirements. People taking blood thinners must be on a stable dose.
  • Be able to sign a consent form and finish the first study tests within 2 weeks before treatment starts. People with HIV may join if they meet the study rules.
  • The listing specifies female patients of any ethnic group. Women must have had surgery to prevent pregnancy, have had no periods for at least one year, or use approved birth control. It also says men must use approved birth control. Timing sex, withdrawal, and not having sex do not count as approved methods.

Who can't join

  • Have taken capecitabine before for breast cancer that had spread to other parts of the body.
  • Have no tumors that can be measured.
  • Have severe liver or kidney failure.
  • Cannot swallow pills.
  • Have HER2-positive breast cancer.
  • Had major surgery within 3 weeks before joining the study.
  • Have pressure on the spinal cord that has not been fully treated with surgery or radiation, or has not stayed stable for more than 2 weeks before treatment starts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. 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 • Patients with known Gilbert disease who have serum bilirubin level ≤3 x ULN may be enrolled. 6. 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. 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. 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)

Study sites (1)

AL