AC regimen for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast CancerAC regimen - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two different chemotherapy regimens to see which is more effective in treating patients with stage I-III breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years

Year 5
Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group
Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group
Year 5
Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
Year 5
Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.
Therapeutic procedure
Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
Year 5
Overall Survival
Week 4
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Year 5
Disease-free Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Arm III (Paclitaxel for 4 Courses)
58%Peripheral sensory neuropathy
39%Hemoglobin decreased
22%Diarrhea
18%Leukocyte count decreased
13%Neutrophil count decreased
12%Mucositis oral
11%Platelet count decreased
10%Hypersensitivity
10%Peripheral motor neuropathy
5%Myalgia
5%Fatigue
5%Blood glucose increased
5%Bone pain
4%Arthralgia
3%Arrhythmia
3%Alopecia
2%Alanine aminotransferase increased
2%Nausea
2%Left ventricular failure
2%Hot flashes
1%Insomnia
1%Dysgeusia
1%Constipation
1%Alkaline phosphatase
1%Pain
1%Dyspnea (shortness of breath)
1%Infection without neutropenia
1%Abdominal pain
1%Vomiting
1%Pain in extremity
1%Depression
1%Anxiety
1%Thrombosis
1%Aspartate aminotransferase increased
1%Lymphocyte count decreased
1%Serum potassium decreased
1%Dizziness
1%Pruritus
1%Rash desquamating
1%Hypertension
1%Headache
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT00041119) in the Arm III (Paclitaxel for 4 Courses) ARM group. Side effects include: Peripheral sensory neuropathy with 58%, Hemoglobin decreased with 39%, Diarrhea with 22%, Leukocyte count decreased with 18%, Neutrophil count decreased with 13%.

Trial Design

6 Treatment Groups

Arm III
1 of 6
Arm I
1 of 6
Arm II
1 of 6
Arm IV
1 of 6
Arm V
1 of 6
Arm VI
1 of 6

Active Control

Experimental Treatment

3294 Total Participants · 6 Treatment Groups

Primary Treatment: AC regimen · No Placebo Group · Phase 3

Arm IIExperimental Group · 5 Interventions: doxorubicin hydrochloride, pegfilgrastim, paclitaxel, AC regimen, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug
Arm IVExperimental Group · 5 Interventions: doxorubicin hydrochloride, pegfilgrastim, paclitaxel, AC regimen, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug
Arm VExperimental Group · 5 Interventions: doxorubicin hydrochloride, pegfilgrastim, paclitaxel, AC regimen, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug
Arm VIExperimental Group · 5 Interventions: doxorubicin hydrochloride, pegfilgrastim, paclitaxel, AC regimen, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug
Arm IIIActiveComparator Group · 5 Interventions: doxorubicin hydrochloride, pegfilgrastim, paclitaxel, AC regimen, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug
Arm IActiveComparator Group · 5 Interventions: doxorubicin hydrochloride, pegfilgrastim, paclitaxel, AC regimen, cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Pegfilgrastim
FDA approved
Paclitaxel
FDA approved
AC regimen
2006
Completed Phase 3
~3920
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: biomarkers were measured by gene expression analysis before study entry. dfs was measured every 6 months for 5 years

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
387 Previous Clinical Trials
259,659 Total Patients Enrolled
53 Trials studying Breast Cancer
61,993 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,083 Previous Clinical Trials
41,138,264 Total Patients Enrolled
925 Trials studying Breast Cancer
1,533,072 Patients Enrolled for Breast Cancer
Halle C Moore, MDStudy DirectorThe Cleveland Clinic
1 Previous Clinical Trials
257 Total Patients Enrolled
1 Trials studying Breast Cancer
257 Patients Enrolled for Breast Cancer
George Thomas Budd, MDStudy ChairThe Cleveland Clinic
3 Previous Clinical Trials
1,530 Total Patients Enrolled
2 Trials studying Breast Cancer
1,500 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who are node negative on the basis of a sentinel node procedure and fewer than 6 axillary or intramammary nodes are eligible.
You have histologically confirmed stage I-III invasive breast cancer.
Tumor ≥ 2 cm in greatest dimension.
Patients with nodal status of N0+ (i.e., no cluster of tumor cells in any node greater than 0.
You have an estrogen receptor-negative and a progesterone receptor-negative cancer.
You have estrogen receptor-positive or PgR-positive with a genomic health recurrence score of at least 26.
One or more axillary or intramammary nodes are involved by metastatic breast cancer.