Combination Chemotherapy in Treating Patients With Breast Cancer
NCT ID: NCT00003088
Last Updated: 2020-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2005 participants
INTERVENTIONAL
1997-09-30
2003-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sequential chemotherapy 21 days
Patients received doxorubicin 60 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles followed by cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles.
cyclophosphamide
given IV
doxorubicin hydrochloride
given IV
paclitaxel
given IV
Concurrent chemotherapy 14 days
Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 2 weeks for four cycles with filgrastim days 3 to 10 of each cycle at 5 µg/kg rounded to either 300 or 480 µg total dose.
cyclophosphamide
given IV
doxorubicin hydrochloride
given IV
paclitaxel
given IV
Sequential chemotherapy 14 days
Patients received doxorubicin 60 mg/m2 every 2 weeks for four cycles followed by paclitaxel 175 mg/m2 every 2 weeks for four cycles followed by cyclophosphamide 600 mg/m2 every 2 weeks for four cycles, with filgrastim days 3 to 10 of each cycle (a total of seven doses) at 5 µg/kg, which could be rounded to either 300 or 480 µg total dose.
cyclophosphamide
given IV
doxorubicin hydrochloride
given IV
paclitaxel
given IV
Concurrent chemotherapy 21 days
Patients received doxorubicin 60 mg/m\^2 plus cyclophosphamide 600 mg/m\^2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m\^2 every 3 weeks for four cycles.
cyclophosphamide
given IV
doxorubicin hydrochloride
given IV
paclitaxel
given IV
Interventions
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cyclophosphamide
given IV
doxorubicin hydrochloride
given IV
paclitaxel
given IV
Eligibility Criteria
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Inclusion Criteria
1.3 Patients with any ERP/PgR status are eligible.
2. Prior treatment:
2.1 \<84 days from mastectomy or within 84 days of axillary dissection if the patient's most extensive breast surgery was a breast sparing procedure.
2.2 Surgical resection margins - All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy. Node dissection: patients may have had either an axillary node dissection or sentinel lymph node biopsy before beginning treatment on protocol.
* Mastectomy: There should be no evidence of gross or microscopic 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.
2.3 No prior chemotherapy.
2.4 No prior radiation therapy for this malignancy. Patients who received radiation to the breast for DCIS are eligible. Patients who have had segmental mastectomy will be treated with radiotherapy according to standard procedures in the treating physician's institution after completion of all chemotherapy. Patients who have had modified radical mastectomy may also receive radiotherapy at the discretion of the treating physician according to institutional guidelines.
2.5 Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen therapy should be discontinued before the patient is enrolled on this study.
3. Age \> 18. There is no upper age limit for enrollment on this study.
4. Required initial laboratory data:
* Granulocyte count \> 1000/mm3
* Platelet count \> 100,000/mm3
* Bilirubin within upper limits of normal
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Marc L. Citron, MD
Role: STUDY_CHAIR
ProHEALTH Care Associates, LLP
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic
Saint Cloud, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Altru Health Systems
Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada
Countries
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References
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Muss HB, Berry DA, Cirrincione C, Budman DR, Henderson IC, Citron ML, Norton L, Winer EP, Hudis CA; Cancer and Leukemia Group B Experience. Toxicity of older and younger patients treated with adjuvant chemotherapy for node-positive breast cancer: the Cancer and Leukemia Group B Experience. J Clin Oncol. 2007 Aug 20;25(24):3699-704. doi: 10.1200/JCO.2007.10.9710.
Berry DA, Cirrincione C, Henderson IC, Citron ML, Budman DR, Goldstein LJ, Martino S, Perez EA, Muss HB, Norton L, Hudis C, Winer EP. Estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. JAMA. 2006 Apr 12;295(14):1658-67. doi: 10.1001/jama.295.14.1658.
Muss H, Berry D, Cirrincione C, et al.: Toxicity of older and younger patients (pts) treated (Rx) with intensive adjuvant chemotherapy (Cx) for node-positive (N+) breast cancer (BC): the CALGB experience. [Abstract] J Clin Oncol 24 (Suppl 18): A-559, 2006.
Campone M, Fumoleau P, Bourbouloux E, Kerbrat P, Roche H. Taxanes in adjuvant breast cancer setting: which standard in Europe? Crit Rev Oncol Hematol. 2005 Sep;55(3):167-75. doi: 10.1016/j.critrevonc.2005.04.003.
Orzano JA, Swain SM. Concepts and clinical trials of dose-dense chemotherapy for breast cancer. Clin Breast Cancer. 2005 Dec;6(5):402-11. doi: 10.3816/CBC.2005.n.044.
Berry DA, Cirrincione C, Henderson IC, et al.: Effects of improvements in chemotherapy on disease-free and overall survival of estrogen-receptor negative, node-positive breast cancer: 20-year experience of the CALGB U.S. Breast Intergroup. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-29, 2004.
Citron ML, Berry DA, Cirrincione C, et al.: Dose-dense (DD) AC followed by paclitaxel is associated with moderate, frequent anemia compared to sequential (S) and/or less DD treatment: update by CALGB on Breast Cancer Intergroup Trial C9741 with ECOG, SWOG, & NCCTG. [Abstract] J Clin Oncol 23 (Suppl 16): A-620, 33s, 2005.
Fornier M, Norton L. Dose-dense adjuvant chemotherapy for primary breast cancer. Breast Cancer Res. 2005;7(2):64-9. doi: 10.1186/bcr1007. Epub 2005 Feb 10.
Hudis C, Citron M, Berry D, et al.: Five year follow-up of INT C9741: dose-dense (DD) chemotherapy (CRx) is safe and effective. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-41, 2005.
Schwartz J, Domchek SM, Hwang WT, Fox K. Evaluation of anemia, neutropenia and skin toxicities in standard or dose-dense doxorubicin/cyclophosphamide (AC)-paclitaxel or docetaxel adjuvant chemotherapy in breast cancer. Ann Oncol. 2005 Feb;16(2):247-52. doi: 10.1093/annonc/mdi058.
Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003 Apr 15;21(8):1431-9. doi: 10.1200/JCO.2003.09.081. Epub 2003 Feb 13.
Citron M, Berry D, Cirrincione C, et al.: Superiority of dose-dense (DD) over conventional scheduling (CS) and equivalence of sequential (SC) vs. combination adjuvant chemotherapy (CC) for node-positive breast cancer (CALGB 9741, INT C9741). [Abstract] Breast Cancer Res Treat 76 (Suppl 1): A-15, 2002.
Metzger Filho O, Ballman K, Campbell J, Liu M, Ligibel J, Watson M, Chen E, Du L, Stover D, Carey L, Partridge A, Kirshner J, Muss H, Hudis C, Winer EP, Norton L, Symmans WF. Adjuvant Dose-Dense Chemotherapy in Hormone Receptor-Positive Breast Cancer. J Clin Oncol. 2025 Apr;43(10):1229-1239. doi: 10.1200/JCO-24-01875. Epub 2025 Jan 2.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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CALGB-9741
Identifier Type: -
Identifier Source: secondary_id
CDR0000065788
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9741
Identifier Type: -
Identifier Source: org_study_id
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