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Age matters: new study looks at how older bodies process breast cancer meds

NCT ID NCT00609791

Knowledge-focused Sponsor: City of Hope Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how age changes the way the body handles a breast cancer drug called nab-paclitaxel. Researchers are studying 40 people with metastatic breast cancer to see if older patients process the drug differently. The goal is to make chemotherapy safer and more effective for people of all ages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Feb 2008

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm male breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010-3000, United States

  • City of Hope Medical Group

    Pasadena, California, 91105, United States

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