Could a gentler chemo work for older breast cancer patients?
NCT ID NCT01463072
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 Hide 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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