Paclitaxel for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Adenocarcinoma+10 More
Paclitaxel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing radium-223 dichloride (a radioactive drug) + paclitaxel (a chemotherapy drug) to see if it's more effective than paclitaxel alone in treating patients with metastatic breast cancer.

Eligible Conditions
  • Adenocarcinoma
  • Breast
  • Metastatic Triple-Negative Breast Carcinoma
  • Metastatic HER2-Negative Breast Carcinoma
  • Bone and Bones
  • Hormone Receptor-Positive Breast Carcinoma
  • Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 2 years

Year 2
PFS
Progression-free survival (PFS)
Year 2
Objective response rate
Year 2
Overall survival (OS)
Year 2
Time to first symptomatic skeletal event (SSE)
Up to 2 years
Qualitative or semi-quantitative 18F-FDG PET/CT reporting of standardized uptake value (SUV)
Day 30
Incidence of adverse events (AEs)
Day 28
Fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Hypophagia
16%Oedema peripheral
16%Diarrhoea
13%Cough
13%Vomting
13%Alanine aminotransferase increased
13%Neurotoxicity
9%Rash
9%Chest discomfort
9%Anaemia
9%Nausea
9%Bone marrow failure
9%Aspartate aminotransferase increased
9%Musculoskeletal pain
9%Headache
9%Pigmentation disorder
6%Transaminases increased
6%Paronychia
6%Flushing
6%Thrombocytopenia
6%Face oedema
6%Insomnia
6%Nasopharyngitis
6%Mouth ulceration
6%Constipation
3%Completed suicide
3%Cataract
3%Infection
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

2 Treatment Groups

Arm II (paclitaxel)
1 of 2
Arm I (paclitaxel, radium Ra 223 dichloride)
1 of 2
Active Control
Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: Paclitaxel · No Placebo Group · Phase 2

Arm I (paclitaxel, radium Ra 223 dichloride)Experimental Group · 5 Interventions: Bone Scan, Biospecimen Collection, Computed Tomography, Paclitaxel, Radium Ra 223 Dichloride · Intervention Types: Procedure, Procedure, Procedure, Drug, Radiation
Arm II (paclitaxel)ActiveComparator Group · 4 Interventions: Bone Scan, Biospecimen Collection, Computed Tomography, Paclitaxel · Intervention Types: Procedure, Procedure, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~670
Computed Tomography
2017
Completed Phase 2
~3410
Paclitaxel
FDA approved
Radium Ra 223 Dichloride
2017
Completed Phase 2
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,818 Total Patients Enrolled
408 Trials studying Adenocarcinoma
79,465 Patients Enrolled for Adenocarcinoma
Jyoti MalhotraPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
5 Previous Clinical Trials
175 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have five or fewer metastases and are asymptomatic.
You have enlarged lymph nodes.\n
You must have had a diagnosis of breast cancer at any time point.
Patient must be eligible to receive therapy with paclitaxel for the treatment of their breast cancer.
Patients with HER2-negative disease (HER2 negativity by immunohistochemistry [IHC] or fluorescent in situ hybridization [FISH] ratio according to the American Society of Clinical Oncology-College of American Pathologists guideline criteria) (Hammond et al., 2010; Wolff et al., 2013).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.