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A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer


OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and
cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for
disease free and overall survival in women with node positive stage II or IIIA breast
cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will
improve disease free and overall survival. III. Compare the toxicity in patients treated
with these regimens.

OUTLINE: This is a randomized study. Patients are randomized into one of four arms
(sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed
by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a
modified radical mastectomy or a segmental mastectomy plus axillary node dissection.
Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Arm
I: Patients receive sequential chemotherapy every 3 weeks. Doxorubicin IV is administered
once every 3 weeks for 4 doses. Paclitaxel IV is then administered over 3 hours once every 3
weeks for 4 doses. Cyclophosphamide IV is administered once every 3 weeks for 4 doses
following paclitaxel. Arm II: Patients receive sequential chemotherapy every 2 weeks.
Doxorubicin IV is administered once every 2 weeks for 4 doses. Paclitaxel IV is then
administered over 3 hours once every 2 weeks for 4 doses. Cyclophosphamide IV is
administered once every 2 weeks for 4 doses following paclitaxel. Filgrastim (G-CSF) is
administered by subcutaneous injection on days 3-10 after each dose of doxorubicin,
paclitaxel, and cyclophosphamide. Arm III: Patients receive combination chemotherapy every 3
weeks. Combination doxorubicin IV and cyclophosphamide IV is administered once every 3 weeks
for 4 doses. Paclitaxel IV is administered over 3 hours once every 3 weeks for 4 doses
following combination chemotherapy. Arm IV: Patients receive combination chemotherapy every
2 weeks. Combination doxorubicin IV and cyclophosphamide IV is administered once every 2
weeks for 4 doses. Paclitaxel IV is administered over 3 hours once every 2 weeks for 4 doses
following combination chemotherapy. G-CSF is administered by subcutaneous injection on days
3-10 after each dose of doxorubicin/cyclophophamide and after each dose of paclitaxel. After
completion of all chemotherapy, patients receive tamoxifen orally for 5 years. Patients
undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed
every 6 months for 5 years, then annually until death.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study within 22
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically diagnosed operable, stage II or IIIA
adenocarcinoma of the breast One or more positive lymph nodes (T0-3, N1-2, and M0)
Metaplastic carcinoma allowed Bilateral breast cancer allowed No metastatic disease Not
locally advanced and no tumors fixed to the chest wall, peau d'orange skin changes, skin
ulcerations, or clinical inflammatory changes Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: Not specified Life expectancy: Not specified Hematopoietic:
Granulocyte count at least 1000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
within upper limits of normal Renal: Not specified Cardiovascular: No uncontrolled or
severe cardiovascular disease No myocardial infarction within 6 months No congestive heart
failure Other: No other serious medical illness No psychoses No active uncontrolled
bacterial, viral, or fungal infection HIV negative Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: No greater than 4 weeks of prior tamoxifen therapy for
malignancy No concurrent tamoxifen therapy Radiotherapy: No prior radiation therapy for
this malignancy Surgery: No greater than 84 days since prior mastectomy or axillary
dissection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Marc L. Citron, MD

Investigator Role:

Study Chair

Investigator Affiliation:

ProHEALTH Care Associates, LLP - Lake Success

Authority:

United States: Federal Government

Study ID:

CDR0000065788

NCT ID:

NCT00003088

Start Date:

September 1997

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080