Active — Not RecruitingPhase 2

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients of Different Ages With Metastatic Breast Cancer

United States40 participantsStarted 2008-02-11

Plain-language summary

RATIONALE: Gathering information from patients of different ages receiving paclitaxel albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors understand how the age of the patient changes the way the drug works. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with metastatic breast cancer.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: Inclusion criteria: * Diagnosis of metastatic breast cancer * Any estrogen receptor, progesterone receptor, or HER-2/neu status allowed as long as the patient will receive paclitaxel albumin-stabilized nanoparticle formulation alone * First- or second-line chemotherapy treatment for metastatic disease planned Exclusion criteria: * Untreated CNS metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * WBC ≥ 3,000/mm³ * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the absence of liver metastases) * Bilirubin ≤ 1.5 mg/dL * Peripheral neuropathy ≤ grade 1 * Creatinine clearance ≥ 30 mL/min (calculated or 24-hour) * Negative pregnancy test * Fertile patients must use effective contraception * Not pregnant or nursing * No known history of allergic reactions to paclitaxel * No serious or uncontrolled infection * Ability to understand and the willingness to sign a written informed consent document PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No ≥ grade 2 toxicity from prior therapy (other than alopecia) * No taxane for adjuvant therapy or metastatic disease within the past 12 months * No other concurrent investigational agents * No other concurrent anticancer therapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is studying how the body processes nanoparticle albumin-bound paclitaxel — specifically how it's absorbed and cleared — rather than directly measuring tumor response, so could you help me understand what that means for what we'd actually learn about whether it's working for me?
2Since this is a Phase 2 trial that is no longer actively recruiting, is there any way to access the preliminary data or findings so far, and how might that information shape my own treatment decision?
3The trial compares patients of different ages, which suggests age may affect how this drug behaves in the body — given my own age and health profile, what does my doctor think about how that might influence both the drug's effectiveness and its side effects for me specifically?
4Before considering this or any trial, should I discuss whether standard chemotherapy options for metastatic breast cancer might be a better first step, and how would that choice affect my eligibility for future studies like this one?
5Because this trial is focused on pharmacokinetics — how the drug moves through the body — rather than survival or quality-of-life outcomes, what additional evidence would my doctor want to see before feeling confident recommending nab-paclitaxel as part of my treatment plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Area Under the Curve Over 24 Hours (AUC24)

Timeframe: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

Mean Clearance (CL)

Timeframe: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

Trial details

NCT IDNCT00609791

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-10-25

Results submitted2022-06-03

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