Birmingham, ALNCT06105684Now EnrollingIRB Ready

Metastatic Breast Cancer Clinical Trial in Birmingham, AL

Access cutting-edge metastatic breast cancer treatment through this phase 2 clinical trial at a research site in Birmingham. Study-provided care at no cost to qualified participants.

Sponsored by University of Alabama at Birmingham

Quick Self-Assessment

See if you qualify for this Birmingham location

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Expert Care in Birmingham

Access metastatic breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic breast cancer treatment provided free

Apply for This Birmingham Location

Check if you qualify for this metastatic breast cancer clinical trial in Birmingham, AL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Birmingham

    Convenient for AL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Birmingham site if eligible
  4. 4Begin participation

About This Metastatic Breast Cancer Study in Birmingham

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.

Sponsor: University of Alabama at Birmingham

Who Can Participate

Inclusion Criteria

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.
Creatinine clearance \> 30 mL/min (measured using Cockcroft-Gault equation or estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study)
Patients must be able to provide signed informed consent.
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).
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.
Complete initial work-up within 2 weeks prior to start of treatment (Cycle 1 Day 1).
Patients known to be HIV positive are eligible if they meet the inclusion criteria.

Exclusion Criteria

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT06105684) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Breast Cancer Treatment Options in Birmingham, AL

If you're searching for metastatic breast cancer treatment options in Birmingham, AL, this clinical trial (NCT06105684) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced metastatic breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic breast cancer clinical trials near you to find additional studies recruiting in your area.

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