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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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ biomarkers were measured by gene expression analysis before study entry. dfs were 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 were 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. dfs were measured every 6 months for 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free Survival

Overall Survival

Secondary study objectives

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

Nausea

Alopecia

Vomiting

Febrile neutropenia

Arrhythmia

Blood glucose increased

Infection without neutropenia

Constipation

Thrombosis

Left ventricular failure

Infection with grade 3 or 4 neutropenia

Headache

Peripheral motor neuropathy

Dyspnea (shortness of breath)

Lymphocyte count decreased

Myalgia

Dry skin

Serum glucose decreased

Pneumonitis

Pain

Irregular menstruation

Serum potassium decreased

Arthralgia

Anorexia

Alkaline phosphatase

Bone pain

Esophagitis

Transfusion: pRBCs

Weight gain

Depression

Hot flashes

Dysgeusia

Sweating

Edema

Hypersensitivity

Allergic rhinitis

Dehydration

Vision blurred

Dyspepsia

Chest pain

Alanine aminotransferase increased

Aspartate aminotransferase increased

Creatinine increased

Anxiety

Insomnia

Urinary frequency

Cough

Hand-and-foot syndrome

Nail disorder

Rash desquamating

100%

80%

60%

40%

20%

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)

Awards & Highlights

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.

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