Therapeutic Conventional Surgery for Breast

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast+23 More
Therapeutic Conventional Surgery - Procedure
Eligibility
Any Age
Female
What conditions do you have?
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Study Summary

This trial studies whether two different interventions can improve patient outcomes when making decisions about breast cancer treatment.

Eligible Conditions
  • Breast
  • Anatomic Stage III Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: At 4-5 weeks post patient randomization

Week 5
Patient cancer worry
Patient knowledge about risks and benefits of local regional treatment
Patient self-efficacy in dealing with breast cancer

Trial Safety

Safety Progress

1 of 3

Side Effects for

Carbo/Topotecan - Carbo/Taxol
98%Neutropenia
92%Leukopenia
76%Anemia
54%Thrombocytopenia
48%Gastrointestinal
43%Constitutional
35%Pain
31%Other Hemotologic
17%Infection/Fever
16%Peripheral neurologic
13%Pulmonary
11%Neurologic
9%Metabolic
9%2nd Primary
6%Dermatologic
5%Allergy
5%Endocrine
5%Hepatic
5%Musculoskeletal
4%Cardiovascular
4%Genitourinary/Renal
3%Ocular/Visual
2%Thrombosis/Embolism
2%Auditory
2%Coagulation
2%Hemorrhage
1%Constipation
1%Infection Without Neutropenia
1%Febrile Neutropenia-Fuo Infect Not Docum
1%Sexual
1%Ileus
1%Vomiting
1%Infection Documented W Grd 3/4 Neutropn.
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT00011986) in the Carbo/Topotecan - Carbo/Taxol ARM group. Side effects include: Neutropenia with 98%, Leukopenia with 92%, Anemia with 76%, Thrombocytopenia with 54%, Gastrointestinal with 48%.

Trial Design

9 Treatment Groups

Clinics 21-25 (usual care)
1 of 9
Arm II: (iCanDecide - S)
1 of 9
Arm I: (iCanDecide - ESE)
1 of 9
Clinics 6-8 (CDB)
1 of 9
Clinics 9-11 (CDB)
1 of 9
Clinics 15-17 (CDB)
1 of 9
Clinics 12-14 (CDB)
1 of 9
Clinics 1-5: (CDB)
1 of 9
Clinics 18-20 (CDB)
1 of 9
Active Control
Experimental Treatment

700 Total Participants · 9 Treatment Groups

Primary Treatment: Therapeutic Conventional Surgery · No Placebo Group · N/A

Arm I: (iCanDecide - ESE)Experimental Group · 5 Interventions: Survey Administration, Quality-of-Life Assessment, Therapeutic Conventional Surgery, Interview, Decision Aid iCanDecide - ESE website · Intervention Types: Other, Other, Procedure, Other, Other
Clinics 6-8 (CDB)Experimental Group · 4 Interventions: Survey Administration, Interview, Training, Media Intervention · Intervention Types: Other, Other, Other, Other
Clinics 9-11 (CDB)Experimental Group · 4 Interventions: Survey Administration, Interview, Training, Media Intervention · Intervention Types: Other, Other, Other, Other
Clinics 15-17 (CDB)Experimental Group · 4 Interventions: Survey Administration, Interview, Training, Media Intervention · Intervention Types: Other, Other, Other, Other
Clinics 12-14 (CDB)Experimental Group · 4 Interventions: Survey Administration, Interview, Training, Media Intervention · Intervention Types: Other, Other, Other, Other
Clinics 1-5: (CDB)Experimental Group · 4 Interventions: Survey Administration, Interview, Training, Media Intervention · Intervention Types: Other, Other, Other, Other
Clinics 18-20 (CDB)Experimental Group · 4 Interventions: Survey Administration, Interview, Training, Media Intervention · Intervention Types: Other, Other, Other, Other
Clinics 21-25 (usual care)ActiveComparator Group · 4 Interventions: Best Practice, Survey Administration, Interview, Training · Intervention Types: Other, Other, Other, Other
Arm II: (iCanDecide - S)ActiveComparator Group · 5 Interventions: Survey Administration, Quality-of-Life Assessment, Decision Aid iCanDecide - S website, Therapeutic Conventional Surgery, Interview · Intervention Types: Other, Other, Other, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 4-5 weeks post patient randomization

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
497 Previous Clinical Trials
213,976 Total Patients Enrolled
National Cancer Institute (NCI)NIH
12,989 Previous Clinical Trials
41,298,358 Total Patients Enrolled
3 Trials studying Breast
980 Patients Enrolled for Breast
Sarah T. Hawley, PhD, MPHStudy ChairUniversity of Michigan School of Medicine and Public Health
2 Previous Clinical Trials
882 Total Patients Enrolled

Eligibility Criteria

Age Any Age · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Men are recommended to undergo surgery to treat breast cancer, but men are not recommended to undergo surgery to treat breast cancer.
You are a practicing physician who has been practicing for at least 5 years.
Clinicians must agree to have their patients recruited for the entire time the study is open at their practice, which will include time periods in which the clinicians will and time periods in which they will not have access to the CDB.
Patients will be recruited from practices that have consented to participate in the clinician dashboard practice-level intervention
Clinicians eligible for this study include: breast surgeons and their designee(s) (e.g., physician assistants, nurse practitioners, clinical nurse specialists, or nurses) that participate in the treatment decision-making process

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 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.