Could a gentler chemo work for older breast cancer patients?

NCT ID NCT01463072

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 ยท Last updated Jul 10, 2026

Summary

This study looks at how well older patients (65 and up) with advanced or metastatic breast cancer tolerate a chemotherapy drug called Abraxane. The goal is to see what side effects occur and whether the drug can control tumor growth. Participants receive Abraxane intravenously, and researchers track side effects, dose adjustments, and tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abraxane (nab-paclitaxel)
What this could lead to
If successful, this could show that Abraxane is a well-tolerated chemotherapy option for older adults with advanced breast cancer, potentially improving quality of life during treatment.
What could go wrong
This is a small Phase 2 trial focused on side effects, not a large efficacy study. The drug may still cause significant toxicity, and results may not apply to all older patients.

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

Jun 2012

Expected to finish

Apr 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

65 years and older

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.

Inclusion Criteria: * Locally advanced or metastatic breast cancer * Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone * First or second line chemotherapy treatment for metastatic disease * Karnofsky performance status (KPS) \>= 70% * Resolution of grade \>= 2 toxicity from prior therapy (other than alopecia) * Peripheral neuropathy =\< grade 1 * Absolute neutrophil count \>= 1,500/mm\^3 * Platelets \>= 100,000 cells/mm\^3 * Hemoglobin (Hb) \>= 9.0 g/dl * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal * Alkaline phosphatase =\< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases * Bilirubin =\< 1.5 mg/dl * Creatinine clearance (calculated or 24 hour) \>= 30 ml/min * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients may not be receiving any other investigational agents * Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids * Known history of allergic reactions to paclitaxel * Presence of any serious or uncontrolled infection * Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope Antelope Valley

    Lancaster, California, 93534, United States

  • City of Hope South Pasadena

    South Pasadena, California, 91030, United States

  • City of Hope medical

    Duarte, California, 91010, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

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