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Alkylating agents
Chemotherapy for Breast Cancer
Phase 3
Waitlist Available
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior modified radical mastectomy or local excision of all tumors with axillary lymph node dissection or sentinel node resection required
Operable disease: Stage I, II, IIIA, and IIIC (T1-3, N3a only) with no T4 tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up biomarkers were measured by gene expression analysis before study entry. os was measured every 6 months for 5 years
Awards & highlights
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.
Who is the study for?
This trial is for patients who've had surgery for stage I-III breast cancer. Eligible participants must have operable disease with no T4 tumors, high-risk features based on tumor size and nodal status, and known hormone receptor status. HER2/neu-positive tumors are allowed. Those with HIV, prior malignancy within 5 years (except certain skin or in situ cancers), or previous chemotherapy with specific drugs cannot join.Check my eligibility
What is being tested?
The study compares two post-surgery chemo regimens using doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see which is more effective against resected breast cancer. It's a phase III trial where patients are randomly assigned to one of the two drug combinations.See study design
What are the potential side effects?
Possible side effects include nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts from doxorubicin and cyclophosphamide; numbness or pain from nerve damage caused by paclitaxel; allergic reactions; heart problems; and bone marrow suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery to remove breast cancer and affected lymph nodes.
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My cancer is at an early or mid-stage and can be operated on.
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I know my cancer's estrogen and progesterone receptor status.
Select...
My tumor is HER2/neu-positive.
Select...
My breast cancer is confirmed and not spread beyond stage III.
Select...
My tumor is larger than 2 cm or larger than 1 cm with specific features.
Select...
My cancer has not spread to my lymph nodes and my tumor is at least 1 cm with high-risk features or larger than 2 cm.
Select...
My breast cancer has spread to my lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ biomarkers were measured by gene expression analysis before study entry. dfs was measured every 6 months for 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~biomarkers were measured by gene expression analysis before study entry. dfs was measured every 6 months for 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free Survival
Overall Survival
Secondary outcome measures
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
Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group
+4 moreSide effects data
From 2014 Phase 3 trial • 3871 Patients • NCT0004111968%
Hemoglobin decreased
47%
Leukocyte count decreased
42%
Mucositis oral
40%
Neutrophil count decreased
26%
Diarrhea
22%
Platelet count decreased
13%
Peripheral sensory neuropathy
10%
Fatigue
9%
Nausea
6%
Alopecia
4%
Vomiting
4%
Febrile neutropenia
4%
Arrhythmia
3%
Blood glucose increased
2%
Constipation
2%
Infection without neutropenia
2%
Thrombosis
2%
Left ventricular failure
2%
Infection with grade 3 or 4 neutropenia
2%
Headache
2%
Peripheral motor neuropathy
2%
Dyspnea (shortness of breath)
1%
Serum potassium decreased
1%
Dry skin
1%
Serum glucose decreased
1%
Bone pain
1%
Pneumonitis
1%
Lymphocyte count decreased
1%
Alkaline phosphatase
1%
Pain
1%
Irregular menstruation
1%
Esophagitis
1%
Anorexia
1%
Transfusion: pRBCs
1%
Weight gain
1%
Depression
1%
Hot flashes
1%
Dysgeusia
1%
Sweating
1%
Edema
1%
Hypersensitivity
1%
Allergic rhinitis
1%
Dehydration
1%
Vision blurred
1%
Dyspepsia
1%
Chest pain
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
Creatinine increased
1%
Arthralgia
1%
Myalgia
1%
Anxiety
1%
Insomnia
1%
Urinary frequency
1%
Cough
1%
Hand-and-foot syndrome
1%
Nail disorder
1%
Rash desquamating
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])
Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])
Arm I (CA for 4 Courses)
Arm III (Paclitaxel for 4 Courses)
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Arm VIExperimental Treatment5 Interventions
Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm V. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
Group II: Arm VExperimental Treatment5 Interventions
Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Group III: Arm IVExperimental Treatment5 Interventions
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.
Group IV: Arm IIExperimental Treatment5 Interventions
(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.
Group V: Arm IActive Control5 Interventions
(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.
Group VI: Arm IIIActive Control5 Interventions
(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
doxorubicin hydrochloride
1994
Completed Phase 3
~9590
pegfilgrastim
2011
Completed Phase 3
~3280
paclitaxel
1996
Completed Phase 3
~4310
AC regimen
2006
Completed Phase 3
~3920
cyclophosphamide
1994
Completed Phase 3
~8140
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
261,876 Total Patients Enrolled
53 Trials studying Breast Cancer
62,032 Patients Enrolled for Breast Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
258,517 Total Patients Enrolled
53 Trials studying Breast Cancer
62,032 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,929,859 Total Patients Enrolled
939 Trials studying Breast Cancer
1,540,066 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to remove breast cancer and affected lymph nodes.My tumor is not HER2 positive.I haven't had cancer in the past 5 years, except for certain skin cancers or early-stage cervical or breast cancer.My cancer is at an early or mid-stage and can be operated on.I know my cancer's estrogen and progesterone receptor status.My tumor is smaller than 1 cm and doesn't meet certain criteria.My tumor is HER2/neu-positive.I have breast cancer in both breasts, diagnosed within a month of each other, and the more advanced tumor meets the study criteria.My breast cancer is confirmed and not spread beyond stage III.My tumor is larger than 2 cm or larger than 1 cm with specific features.My cancer has not spread to my lymph nodes and my tumor is at least 1 cm with high-risk features or larger than 2 cm.My cancer has not spread to nearby tissues.My breast cancer has not spread to underarm or breast nodes.My breast cancer has spread to my lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm III
- Group 3: Arm V
- Group 4: Arm II
- Group 5: Arm IV
- Group 6: Arm VI
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the dangers associated with the AC regimen?
"The AC regimen has been studied in multiple Phase 3 trials, so it received a score of 3."
Answered by AI
What does the existing research say about AC therapy?
"The AC regimen was first explored in 1997 at the Spectrum Health Hospital - Butterworth Campus. In the 24 years since, there have been 2495 completed studies. Currently, there are 1780 clinical trials in progress, many of which are based in South Bend, Indiana."
Answered by AI
What type of illness does AC regimen usually target?
"The AC regimen is a course of treatment that is not only effective for leukemia, but also for other conditions such as locally advanced non-small cell lung cancer, metastatic bladder cancer, and lung cancers."
Answered by AI
Are there still unfilled positions in this research project?
"According to the listing on clinicaltrials.gov, this study is no longer recruiting patients. The trial was first posted on November 1st, 2003 and was last edited on January 19th, 2022. There are 4457 other trials that are still recruiting patients."
Answered by AI
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