Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Nab-Paclitaxel vid behandling av äldre patienter med lokalt avancerad eller metastaserad bröstcancer

16 oktober 2026 uppdaterad av: City of Hope Medical Center

Effekt och tolerabilitet av nanopartikelalbuminbundet paklitaxel (Abraxane) hos patienter 65 och äldre med lokalt avancerad eller metastaserad bröstcancer

This phase II trial studies the side effects of nab-paclitaxel in treating older patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVE:

I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer using a stratification factor based on patient age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70 years).

II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.

OUTLINE:

Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Studietyp

Interventionell

Inskrivning (Faktisk)

40

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Duarte, California, Förenta staterna, 91010
        • City of Hope medical
      • Lancaster, California, Förenta staterna, 93534
        • City of Hope Antelope Valley
      • South Pasadena, California, Förenta staterna, 91030
        • City of Hope South Pasadena
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43210
        • Ohio State University Comprehensive Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment (nab-paclitaxel)

Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Övrig: Laboratory Biomarker Analysis

Correlative studies

Övrig: Questionnaire Administration

Ancillary studies

Läkemedel: Nab-paclitaxel

Given IV

Andra namn:
  • ABI-007
  • Abraxane
  • Albuminbundet paklitaxel
  • ABI 007
  • Albumin-stabiliserad nanopartikel paklitaxel
  • Nanopartikel Albuminbundet paklitaxel
  • Nanopartikel Paklitaxel
  • Paklitaxel Albumin
  • paklitaxelalbuminstabiliserad nanopartikelformulering
  • proteinbundet paklitaxel

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
Tidsram: During and after treatment, up to 2.5 years

Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment.
During and after treatment, up to 2.5 years
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
Tidsram: On treatment, 28 days per cycle up to 30 months

Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to treatment.
On treatment, 28 days per cycle up to 30 months
Rate of Participants With a Dose Reduction
Tidsram: On treatment, up to 30 months

Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
On treatment, up to 30 months
Rate of Participants Requiring Dose Holds
Tidsram: While on treatment, up to 30 months

Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
While on treatment, up to 30 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Response Determined by Response Evaluation Criteria in Solid Tumors
Tidsram: Up to 2.5 years

Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for objective response rate (complete response [CR] + partial response [PR]).

RECIST:

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Additionally, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Up to 2.5 years
Median Progression Free Survival (PFS)
Tidsram: From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years

PFS will be estimated using the product limit method of Kaplan and Meier.
From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
Cancer-specific Geriatric (CARG) Assessment
Tidsram: CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months

General linear models and descriptive methods will be used to explore factors as identified by a CARG assessment that may be predictive of toxicity (grade 3 or higher adverse events) or dose reduction.

The cancer specific geriatric assessment score includes an evaluation of functional status, co-morbidity, cognition, psychological stats, social functioning and support, and nutritional status. It assesses a patient's age, gender, height, weight, cancer type, dosage, number of chemotherapy agents, hemoglobin, hearing, number of falls in past 6 months, able to take own medicine, whether walking is limited, have physical or emotional problems interfered with social activities and serum creatinine.

Scores can range from 0 to to 1, with a higher score indicating higher risk of chemotherapy toxicity. Scores from 0 to 5 are considered low risk, 6 to 9 are considered intermediate risk, and 10 to 19 are considered high risk.
CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

City of Hope Medical Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Mina Sedrak, City of Hope Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 juni 2012

Primärt slutförande (Faktisk)

17 maj 2017

Avslutad studie (Beräknad)

20 april 2027

Studieregistreringsdatum

Först inskickad

25 oktober 2011

Först inskickad som uppfyllde QC-kriterierna

31 oktober 2011

Första postat (Beräknad)

1 november 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 11139
  • P30CA033572 (U.S.S. NIH-anslag/kontrakt)
  • 11139 (Annan identifierare: City of Hope Comprehensive Cancer Center)
  • NCI-2011-03295 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • 118196
  • 124494

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera