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Taxane

Chemotherapy for Advanced Breast Cancer

Phase 2
Waitlist Available
Led By Mina Sedrak
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Summary

This trial looks at the side effects of a chemotherapy drug in treating older patients with breast cancer.

Who is the study for?
This trial is for older adults with breast cancer that has spread locally or to other body parts. Participants need a certain level of kidney function, blood cell counts, and liver health; they must understand the study and agree to participate. They should be relatively fit (KPS >= 70%) and not have had taxane drugs recently or severe nerve damage from past treatments.
What is being tested?
The trial is testing nab-paclitaxel's effectiveness in managing advanced breast cancer in older patients. It looks at how well this chemotherapy drug works alone without combining it with other treatments, focusing on its safety profile and impact on tumor growth.
What are the potential side effects?
Nab-paclitaxel can cause side effects like allergic reactions similar to those seen with paclitaxel, low blood cell counts which may increase infection risk, potential liver issues, fatigue, neuropathy (nerve pain), and possibly worsen any pre-existing conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
Rate of Participants Requiring Dose Holds
+1 more
Secondary study objectives
Cancer-specific Geriatric (CARG) Assessment
Median Progression Free Survival (PFS)
Response Determined by Response Evaluation Criteria in Solid Tumors

Side effects data

From 2016 Phase 3 trial • 50 Patients • NCT02019277
70%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Lacrimation increased
8%
Febrile neutropenia
8%
Rash pustular
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Device related infection
2%
Gastroenteritis
2%
Wound infection
2%
Femur fracture
2%
Breast cancer
2%
Syncope
2%
Psychotic disorder
2%
Dermatitis bullous
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nab-paclitaxel)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,497 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,960 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Mina SedrakPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
131 Total Patients Enrolled

Media Library

Nab-paclitaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT01463072 — Phase 2
Breast Cancer Research Study Groups: Treatment (nab-paclitaxel)
Breast Cancer Clinical Trial 2023: Nab-paclitaxel Highlights & Side Effects. Trial Name: NCT01463072 — Phase 2
Nab-paclitaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01463072 — Phase 2
~3 spots leftby Sep 2025
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