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A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer


OBJECTIVES:

- Compare the disease-free survival and overall survival in patients with node-positive
or high-risk node-negative operable stage II or IIIA breast cancer treated with
docetaxel or paclitaxel after doxorubicin and cyclophosphamide.

- Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks
improves disease-free survival and overall survival when compared with the conventional
schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this
patient population.

- Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12
weeks versus every 3 weeks for 4 courses in these patients.

- Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly
for 12 weeks to that of docetaxel administered on the same schedules in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes
vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no
more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs
breast conservation surgery). Patients are randomized to one of four treatment arms.

- Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4
courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours
every 3 weeks for 4 courses.

- Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks.

- Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses.

- Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive docetaxel IV over 1 hour weekly for 12 weeks.

Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone
receptor positive tumors receive oral tamoxifen daily for 5 years.

After completion of all chemotherapy, patients with prior segmental mastectomy receive
radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical
mastectomy may receive radiotherapy after chemotherapy completion at the investigator's
discretion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the
breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR
high-risk node-negative disease (T2 or 3; N0)

- Primary tumor at least 2.1 cm in diameter for node-negative disease

- Bilateral breast disease allowed if at least 1 primary tumor meets the criteria
above

- Must have had at least 6 axillary lymph nodes removed at dissection and at least one
node positive for metastasis OR

- Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed
if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to
receive no axillary dissection)

- Additional axillary nodes may be obtained provided they are also negative for
metastasis

- Complete tumor removal by either a modified radical mastectomy or local excision plus
axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node
biopsy

- Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma
except for lobular carcinoma in situ (less than 1 mm allowed)

- Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP
B-32 allowed

- Hormone receptor status:

- Estrogen receptor status positive, negative, or unknown

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No history of myocardial infarction

- No congestive heart failure

- No significant ischemic or valvular heart disease

Other:

- No other prior invasive malignancies within the past 5 years except curatively
treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

- No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs
(with Cremophor or polysorbate)

- Not pregnant or nursing

- Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for breast cancer

Endocrine therapy:

- Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed

- Prior tamoxifen or other selective estrogen receptor modulator (SERM) for
chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications
(e.g., osteoporosis) allowed

- No concurrent tamoxifen or other SERMs

Radiotherapy:

- No prior radiotherapy for this malignancy

- At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ

Surgery:

- See Disease Characteristics

- Less than 84 days since prior surgical procedure to adequately treat primary tumor

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joseph A. Sparano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067353

NCT ID:

NCT00004125

Start Date:

October 1999

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Schneider Children's Hospital at North ShoreManhasset, New York  11030