|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041119 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving cyclophosphamide together with doxorubicin is more effective than giving paclitaxel alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying cyclophosphamide and doxorubicin to see how well they work compared to paclitaxel in treating women with invasive breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| 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 |
|---|---|
|
Arm I: Active Comparator
Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment repeats every 14 days for 4 courses.
|
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
|
|
Arm II (closed to accrual as of 1/30/2008): Experimental
Patients receive doxorubicin and cyclophosphamide as in arm I. Treatment repeats every 14 days for 6 courses.
|
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
|
|
Arm III: Experimental
Patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 14 days for 4 courses.
|
Drug: paclitaxel
Given IV
|
|
Arm IV (closed to accrual as of 1/30/2008): Experimental
Patients receive paclitaxel as in arm III. Treatment repeats every 14 days for 6 courses.
|
Drug: paclitaxel
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal), estrogen receptor (ER)/progesterone receptor (PR) status (ER and/or PR positive or unknown vs ER and PR negative), and HER2/neu status (negative vs unknown vs positive [by immunohistochemistry 3+ staining or gene amplification by fluorescence in situ hybridization]). Patients are randomized to 1 of 4 treatment arms (arms II and IV closed to accrual as of 1/30/2008).
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
Lumpectomy patients must then undergo radiotherapy. Mastectomy patients undergo radiotherapy at the discretion of the treating physician.
Patients are followed every 6 months for 2 years and then annually for 15 years.
PROJECTED ACCRUAL: A total of 4,646 patients will be accrued for this study within 29 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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:
Meets 1 of the following criteria for node-positive disease (1-3 positive axillary lymph nodes):
Modified radical mastectomy or lumpectomy within the past 84 days required
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent exogenous hormonal therapy (including oral contraceptives, postmenopausal hormone replacement therapy, or raloxifene) except:
Surgery:
Other:
Contacts and Locations
Show 528 Study Locations| Study Chair: | Lawrence N. Shulman, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
| Study ID Numbers: | CDR0000069444, CALGB-40101 |
| Study First Received: | July 8, 2002 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00041119 History of Changes |
| Health Authority: | Unspecified |
|
stage I breast cancer stage II breast cancer |
|
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 |