Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Active, enrolledPhase 2Results postedLast updated 28 July 2025
What this trial tests
Phase 2 trial testing Laboratory Biomarker Analysis in Locally Advanced Breast Carcinoma in 40 participants. Participants enrolled and being followed up; not accepting new ones.
65 and older, any sex, with Locally Advanced Breast Carcinoma or Metastatic Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0Primary· 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.
Group
Value
95% CI
Treatment (Nab-paclitaxel)
90
76 – 97
Percent of Participants With Grade 3 or Higher Toxicities Attributable to TreatmentPrimary· 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.
Group
Value
95% CI
Treatment (Nab-paclitaxel)
58
41 – 73
Rate of Participants With a Dose ReductionPrimary· On treatment, up to 30 months
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
Group
Value
95% CI
Treatment (Nab-paclitaxel)
50
34 – 66
Rate of Participants Requiring Dose HoldsPrimary· While on treatment, up to 30 months
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
Group
Value
95% CI
Treatment (Nab-paclitaxel)
75
59 – 87
Response Determined by Response Evaluation Criteria in Solid TumorsSecondary· 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
Group
Value
95% CI
Treatment (Nab-paclitaxel)
1
Treatment (Nab-paclitaxel)
13
Treatment (Nab-paclitaxel)
16
Treatment (Nab-paclitaxel)
4
Median Progression Free Survival (PFS)Secondary· 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.
Group
Value
95% CI
Treatment (Nab-paclitaxel)
6.5
5.5 – NA
Cancer-specific Geriatric (CARG) AssessmentSecondary· 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
Group
Value
95% CI
Treatment (Nab-paclitaxel)
21
Treatment (Nab-paclitaxel)
15
Treatment (Nab-paclitaxel)
4
Adverse events — posted to ClinicalTrials.gov
Time frame: On study, up to 2.5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04142398 — Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
· withdrawn
NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men
· withdrawn
NCT05558904 — An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cance
· Phase 1, PHASE2
· recruiting
NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
· Phase 1
· active not recruiting
NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
· Phase 1
· active not recruiting
Other recruiting trials for Locally Advanced Breast Carcinoma
Currently open trials in the same condition.
NCT07137416 — Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for H
· Phase 1
· recruiting
NCT06999798 — An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast
· Phase 1
· recruiting
NCT04550494 — Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
· Phase 2
· recruiting
NCT04445844 — INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study
· Phase 2
· active not recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
· Phase 2
· not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment
· Phase 1
· not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o
· NA
· withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 28 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01463072.