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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
First or second line chemotherapy treatment for metastatic disease
Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving my first or second round of chemotherapy for cancer that has spread.
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My alkaline phosphatase levels are normal or slightly elevated, and I don't have liver metastases.
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I have recovered from serious side effects of my previous treatment, except for hair loss.
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My kidneys are functioning well enough (creatinine clearance >= 30 ml/min).
Select...
My nerve damage symptoms are mild or not present.
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I am able to care for myself but may not be able to do active work.
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My breast cancer can be any type, but I will be treated with nab-paclitaxel only.
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My breast cancer has spread beyond the original site.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Nail disorder
24%
Arthralgia
22%
Pain in extremity
20%
Urinary tract infection
20%
Back pain
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%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
12%
Hypertension
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
10%
Peripheral sensory neuropathy
8%
Febrile neutropenia
8%
Lacrimation increased
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
8%
Rash pustular
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%
Skin lesion
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
6%
Injection site reaction
6%
Musculoskeletal chest pain
4%
Cellulitis
4%
Pulmonary embolism
2%
Gastroenteritis
2%
Femur fracture
2%
Breast cancer
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Device related infection
2%
Syncope
2%
Psychotic disorder
2%
Dermatitis bullous
2%
Oesophagitis
2%
Sepsis
2%
Wound infection
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
558 Previous Clinical Trials
1,917,412 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,606 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites in North America are facilitating this trial?

"This trial has 4 enrolment sites including City of Hope South Pasadena, City of Hope Antelope Valley, Ohio State University Comprehensive Cancer Centre and a quartet of additional medical centres."

Answered by AI

Is there an enrollment window still open for this clinical trial?

"Per the information posted to clinicaltrials.gov, this particular medical trial is not actively recruiting participants at present. This study first launched on June 19th 2012 and was last updated on June 30th 2022 however there are currently 5414 different trials open for enrollment across the United States of America."

Answered by AI

Has Nab-paclitaxel clearance been granted by the Food and Drug Administration?

"Our experts at Power gave nab-paclitaxel a rating of 2 due to the fact that there is some evidence supporting its safety, but not much regarding efficacy as this treatment is still in Phase 2 trials."

Answered by AI

How many participants are being recruited for the research project?

"Unfortunately, this particular medical trial is no longer accepting patients. It was first made available on June 19th 2012 and the last update occurred on June 30th 2022. However, there are still 4558 trials for breast cancer and 856 studies involving Nab-paclitaxel that are open to participants."

Answered by AI

What therapeutic effects is this investigation expected to yield?

"According to the given trial, ascertainment of primary outcome will be conducted over a 30-month time period and it is focused on evaluating Degree Reduction Rates. Secondary outcomes include Cancer Specific Geriatric (CARG) Assessment which assesses functional status, co-morbidity, cognition capacity, psychological health, social functioning/support and nutrition levels; Time to Progression calculated via Kaplan Meier product limit method; Response Determined by Response Evaluation Criteria in Solid Tumors utilizing rates with 95% exact Clopper & Pearson binomial confidence limits for Objective Response Rate (Complete Response [CR] + Partial Response [PR])."

Answered by AI

Have there been any preceding experiments involving Nab-paclitaxel?

"Nab-paclitaxel was first experimented with in 1997 at the City of Hope Comprehensive Cancer Center. As of today, there have been 1921 trials that have concluded and 856 studies are still ongoing; many located within South Pasadena, Ohio."

Answered by AI

To what therapeutic purpose is Nab-paclitaxel most commonly employed?

"Nab-paclitaxel is primarily used to treat hypoalbuminemia, but can also be effective in patients suffering from acute pyelonephritis (APN), shock, hypovolemic and non-small cell lung cancer."

Answered by AI
~3 spots leftby Mar 2025