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Comparison of Combination Che...

Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Last Updated: 2016-08-12

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

633 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2012-11-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

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Detailed Description

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OBJECTIVES:

* Compare the effectiveness of adjuvant chemotherapy comprising standard cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC) vs oral capecitabine, in terms of disease-free and overall survival, in elderly women with operable adenocarcinoma of the breast.
* Compare the quality of life and physical functioning of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Evaluate the adherence of older patients to an oral chemotherapy regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (65 to 69 vs 70 to 80 vs over 80), performance status (0-1 vs 2), and HER2 status (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients with insufficient left ventricular ejection fraction (LVEF) are assigned to group A. Patients with normal LVEF are assigned to group A or B based on physician/patient choice.

* Group A (CMF): Patients receive oral cyclophosphamide (CTX) daily on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Group B (AC): Patients receive doxorubicin IV and CTX IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Beginning within 12 weeks after treatment in arm I or II, patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen or an aromatase inhibitor daily for 5 years.

Beginning 4-6 weeks after treatment in arm I or II, eligible patients who previously underwent breast conservation surgery undergo radiotherapy.

Quality of life is assessed at baseline; at 6 weeks (group B), 9 weeks (arm II), or 12 weeks (group A); and then at 1, 12, 18, and 24 months after study.

Drug adherence is assessed at 9 weeks during study (arm II).

Patients are followed at 1 month, every 6 months for 2 years, and then annually for 15 years.

PROJECTED ACCRUAL: A total of 600-1,800 patients (300-900 per treatment arm) will be accrued for this study within 2-6 years.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Chemotherapy

Patient/Physician choice of cyclophosphamide + MTX + 5-FU

OR

Cyclophosphamide + doxorubicin

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type DRUG

Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 \& 8 and 5-FU 600 mg/sq m IV push d 1 \& 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles

Capecitabine

Treatment with capecitabine

Group Type EXPERIMENTAL

capecitabine

Intervention Type DRUG

2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles

Interventions

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Standard Treatment

Intervention Type DRUG

capecitabine

2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles

Intervention Type DRUG

Other Intervention Names

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doxorubicin = adriamycin

Eligibility Criteria

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Inclusion Criteria

3. Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.

Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.
4. Age 65 years or older
5. Performance status 0-2 (Common Toxicity Criteria).
6. Prior treatment:

* Surgical resection -

* All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered ≤ 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.
* Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.
* Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor \< 1 mm from margin) are eligible.
* Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible.
* No prior chemotherapy for this malignancy.
* Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.
* Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.
7. Required Initial Laboratory Data:

* Granulocytes \> 1,500/µl
* Platelet count ≥100,000/µl
* Calculated Creatinine Clearance \> 30 mL/min
* Total bilirubin ≤ ULN

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyman B. Muss, MD

Role: STUDY_CHAIR

University of North Carolina

Locations

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University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

St. Joseph's Mercy Cancer Center

Hot Springs, Arkansas, United States

Site Status

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, United States

Site Status

Saint Rose Hospital

Hayward, California, United States

Site Status

Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Leavey Cancer Center at Northridge Hospital Medical Center

Northridge, California, United States

Site Status

Highland General Hospital at St. George's University School of Medicine

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Valley Care Medical Center

Pleasanton, California, United States

Site Status

Salinas Valley Memorial Hospital

Salinas, California, United States

Site Status

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, United States

Site Status

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Site Status

Memorial Hospital

Colorado Springs, Colorado, United States

Site Status

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Site Status

Kent General Hospital at Bayhealth Medical Center

Dover, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Halifax Medical Center - Daytona Beach

Daytona Beach, Florida, United States

Site Status

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Palm Beach Cancer Institute - West Palm Beach

West Palm Beach, Florida, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

Augusta Oncology Associates - Walton Way

Augusta, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

Site Status

Cancer Research Center of Hawaii

Honolula, Hawaii, United States

Site Status

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, United States

Site Status

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, United States

Site Status

St. Francis Medical Center

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Pacific Cancer Institute - Maui

Wailuku, Maui, Hawaii, United States

Site Status

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, United States

Site Status

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status