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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
Must not have
HER2/neu-negative tumors
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

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 below
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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.
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My tumor is HER2/neu-positive.
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My breast cancer is confirmed and not spread beyond stage III.
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My tumor is larger than 2 cm or larger than 1 cm with specific features.
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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.
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My breast cancer has spread to my lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor is not HER2 positive.
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My cancer has not spread to nearby tissues.
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My breast cancer has not spread to underarm or breast nodes.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and biomarkers were measured by gene expression analysis before study entry. os was measured every 6 months for 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
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 more

Side effects data

From 2014 Phase 3 trial • 3871 Patients • NCT00041119
68%
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%
Pain
1%
Irregular menstruation
1%
Serum glucose decreased
1%
Dry skin
1%
Lymphocyte count decreased
1%
Alkaline phosphatase
1%
Pneumonitis
1%
Bone pain
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
395 Previous Clinical Trials
261,854 Total Patients Enrolled
53 Trials studying Breast Cancer
62,032 Patients Enrolled for Breast Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
257,967 Total Patients Enrolled
53 Trials studying Breast Cancer
62,032 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,956,107 Total Patients Enrolled
943 Trials studying Breast Cancer
1,540,714 Patients Enrolled for Breast Cancer

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00070564 — Phase 3
Breast Cancer Research Study Groups: Arm I, Arm III, Arm V, Arm II, Arm IV, Arm VI
Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00070564 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00070564 — Phase 3
~152 spots leftby Jul 2025
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