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Combination Chemotherapy in Treating Women With Breast Cancer
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, June 2008
First Received: June 12, 2008   Last Updated: June 16, 2008   History of Changes
Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
Cancer and Leukemia Group B
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00698217
  Purpose

This purpose of this study is to compare the effectiveness of the standard adjuvant chemotherapy Cyclophosphamide and Doxorubicin (CA) with the chemotherapy drug Paclitaxel. The treatments will be compared to each other to effectiveness to treat your type of cancer and how well you tolerated the treatment that you received.

Cyclophosphamide and Doxorubicin (CA) have been approved by the Food and Drug Administration of the United States (FDA) for the treatment of breast cancer. Paclitaxel given after combination chemotherapy has been approved for the adjuvant treatment of breast cancer that has spread to the lymph nodes. Paclitaxel is also approved for the treatment of breast cancer that has grown or that has spread to other parts of the body after previous chemotherapy. The use of paclitaxel as adjuvant treatment for breast cancer that has not spread to the lymph nodes, as used in this study, are considered to be experimental or research.


Condition Intervention Phase
Breast Cancer
Drug: doxorubicin
Drug: cyclophosphamide
Drug: paclitaxel
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Patients are followed every 6 months for 2 years and then annually for 15 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Patients are followed every 6 months for 2 years and then annually for 15 years. ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Patients are followed every 6 months for 2 years and then annually for 15 years. ] [ Designated as safety issue: Yes ]
  • Myelosuppression in patients with MDR1 haplotypes [ Time Frame: Patients are followed every 6 months for 2 years and then annually for 15 years. ] [ Designated as safety issue: No ]
  • CYP3A5, CYP2C8, and CYP2B6 polymorphisms [ Time Frame: Patients are followed every 6 months for 2 years and then annually for 15 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 4646
Study Start Date: May 2002
Estimated Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator
Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment repeats every 14 days for 4 courses.
Drug: doxorubicin
Patients receive doxorubicin IV
Drug: cyclophosphamide
Patients receive cyclophosphamide IV
II: Active Comparator
(Closed to accrual as of 1/30/2008):Patients receive doxorubicin and cyclophosphamide as in arm I. Treatment repeats every 14 days for 6 courses.
Drug: doxorubicin
Patients receive doxorubicin IV
Drug: cyclophosphamide
Patients receive cyclophosphamide IV
III: Active Comparator
Patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 14 days for 4 courses.
Drug: paclitaxel
Patients receive paclitaxel IV over 1 hour
IV: Active Comparator
(Closed to accrual as of 1/30/2008): Patients receive paclitaxel as in arm III. Treatment repeats every 14 days for 6 courses.
Drug: paclitaxel
Patients receive paclitaxel IV over 1 hour

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive carcinoma of the breast with 0-3 positive axillary lymph nodes
  • Meets 1 of the following criteria for node-negative disease:

    • Negative sentinel lymph node biopsy
    • At least 6 negative axillary lymph nodes removed and determined to be negative by axillary dissection
  • Meets 1 of the following criteria for node-positive disease (1-3 positive axillary lymph nodes):

    • At least 1 positive lymph node by sentinel lymph node biopsy AND at least 6 axillary lymph nodes removed by axillary dissection; of all the nodes removed from both the sentinel lymph node biopsy and the axillary dissection, 1-3 must be positive
    • At least 6 lymph nodes removed by axillary dissection; 1-3 nodes from the axillary dissection must be positive
  • "High-risk" disease that warrants chemotherapy (ultimately determined by the treating physician)
  • Modified radical mastectomy or lumpectomy within the past 84 days required

    • Negative tumor margins for invasive cancer and ductal carcinoma in situ (DCIS)
    • Lobular carcinoma in situ (LCIS) at the margin allowed
  • Multicentric disease allowed provided margins and axillary nodes are negative after resection
  • Bilateral synchronous disease allowed
  • Invasive cancer on one side and DCIS or LCIS on the contralateral side is allowed provided all other eligibility criteria are met
  • No locally advanced, inflammatory, or metastatic breast cancer
  • No dermal lymphatics involvement, even if there are no clinical signs of inflammatory cancer
  • HER2/neu positive, negative, or unknown
  • Hormone receptor status:

    • Any estrogen and/or progesterone receptor status

PATIENT CHARACTERISTICS:

AGE:

  • 18 and over

SEX:

  • Female

MENOPAUSAL STATUS:

  • Premenopausal or postmenopausal

PERFORMANCE STATUS:

  • CTC 0-1

LIFE EXPECTANCY:

  • Not specified

HEMATOPOIETIC:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

HEPATIC:

  • Bilirubin no greater than 1.5 times upper limit of normal

RENAL:

  • Creatinine no greater than 2.0 mg/dL

CARDIOVASCULAR:

  • No active congestive heart failure
  • No myocardial infarction within the past 6 months

OTHER:

  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

BIOLOGIC THERAPY:

  • No prior trastuzumab (Herceptin^®) for this malignancy

CHEMOTHERAPY:

  • See Disease Characteristics
  • No prior chemotherapy for this malignancy
  • No other concurrent chemotherapy

ENDOCRINE THERAPY:

  • No prior hormonal therapy for this malignancy except tamoxifen given for up to 4 weeks
  • Prior tamoxifen or other selective estrogen receptor modulators (SERMs) for prevention or other indications (e.g., osteoporosis) allowed
  • No concurrent exogenous hormonal therapy (including oral contraceptives, postmenopausal hormone replacement therapy, or raloxifene) except:

    • Steroids for adrenal failure
    • Hormonal agents for nondisease-related conditions (e.g., insulin for diabetes or synthroid for hypothyroidism)
    • Intermittent dexamethasone as an antiemetic and premedication for paclitaxel
  • No concurrent tamoxifen or other SERMs

SURGERY:

  • See Disease Characteristics

OTHER:

  • No concurrent dexrazoxane
  • No concurrent raloxifene
  • Concurrent bisphosphonates for osteoporosis allowed
  • Concurrent trastuzumab (Herceptin®) allowed for patients with HER2-positive disease
  • Concurrent enrollment on adjuvant bisphosphonate studies allowed
  • Concurrent enrollment on adjuvant hormonal studies allowed provided hormonal therapy does not commence until completion of study chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698217

Contacts
Contact: Lillian Pliner, MD 9739726257 plinerlf@umdnj.edu
Contact: Yasmeen S. Barber, BA 9739727789 barberys@umdnj.edu

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Newark, New Jersey, United States, 07101-1709
Contact: Yasmeen S Barber, BA     973-972-7789     barberys@umdnj.edu    
Principal Investigator: Lillian Pliner, MD            
Sub-Investigator: Margarette Bryan, MD            
Sub-Investigator: Meera Hameed, MD            
Sub-Investigator: Dolly Razdan, MD            
Sub-Investigator: Charles Cathcart, MD            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Cancer and Leukemia Group B
Investigators
Study Chair: Lawrence N. Shulman, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Dana Farber Cancer Institute ( Lawrence N. Shulman, MD, Study Chair )
Study ID Numbers: 0120070073
Study First Received: June 12, 2008
Last Updated: June 16, 2008
ClinicalTrials.gov Identifier: NCT00698217     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Skin Diseases
Immunologic Factors
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Cyclophosphamide
Immunosuppressive Agents
Doxorubicin
Anti-Bacterial Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Breast Diseases

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Breast Neoplasms
Antimitotic Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009