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NSABP Clinical Trials Overview


Treatment Trials Open to Accrual

Prevention Trials Open to Accrual

Treatment Trials Closed to Accrual

Prevention Trials Closed to Accrual



Treatment Trials Open to Accrual

B-43 A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
B-47 A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
B-51 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy


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Treatment Trials Closed to Accrual

B-04 A Protocol for the Evaluation of Radical Mastectomy and Total Mastectomy With and Without Radiation in the Primary Treatment of Cancer of the Female Breast
B-05 A Protocol for the Evaluation of Prolonged Therapy of Mammary Carcinoma With L-phenylalanine Mustard (L-PAM) as an Adjuvant to Surgery
B-06 A Protocol to Compare Segmental Mastectomy and Axillary Dissection With and Without Radiation of the Breast and Total Mastectomy and Axillary Dissection
B-07 A Protocol to Compare Prolonged Therapy of Mammary Carcinoma by the Administration of L-phenylalanine Mustard (L-PAM) with L-PAM plus 5-Fluorouracil (5-FU)
B-08 A Protocol to Compare Prolonged Therapy of Mammary Carcinoma by the Administration of L-phenylalanine Mustard (L-PAM) plus 5-Fluorouracil (5-FU) with L-PAM plus 5-FU plus Methotrexate (MTX)
B-09 A Protocol to Compare Combined Chemotherapy With and Without Tamoxifen in the Management of Patients With Surgically Curable Breast Cancer
B-10 A Protocol to Compare Combined Chemotherapy With and Without C. parvum + Hydrocortisone in The Management of Patients with Surgically Curable Breast Cancer
B-11 A Protocol to Compare L-PAM and 5-FU With and Without Adriamycin in the Management of Primary Breast Cancer Patients with Positive Axillary Nodes Whose Tumors are Negative for Estrogen Receptors and/or Progesterone Receptors
B-12 A Protocol to Compare L-PAM, 5-FU and Tamoxifen With and Without Adriamycin in the Management of Primary Breast Cancer Patients With Positive Axillary Nodes Whose Tumors are Positive for Estrogen and/or Progesterone Receptors
B-13 A Protocol To Assess Sequential Methotrexate → Fluorouracil In Patients With Primary Breast Cancer And Negative Axillary Nodes Whose Tumors Are Negative For Estrogen Receptors
B-14 A Clinical Trial to Assess Tamoxifen in Patients With Primary Breast Cancer and Negative Axillary Nodes Whose Tumors are Positive for Estrogen Receptors
B-15 A Three-Arm Clinical Trial Comparing Short, Intensive Adriamycin-Cyclophosphamide Chemotherapy With and Without Interval Reinduction Chemotherapy (CMF) to "Conventional" CMF in Positive-Node Patients Having The Following Age and Receptor Criteria:
49 Years or younger - All Patients
50-59 Years - PR <10 fmol, regardless of ER
B-16 A Three-Arm Clinical Trial Comparing Tamoxifen Alone with L-PAM, 5-FU, Adriamycin and Tamoxifen or with Short, Intensive Adriamycin-Cyclophosphamide and Tamoxifen in Positive-Node Patients Having the Following Age and Receptor Criteria:
50-59 Years - PR = 10 fmol or more, regardless of ER
60-70 Years - All Patients
B-17 A Protocol to Evaluate Natural History and Treatment of Patients with Noninvasive Intraductal Adenocarcinoma
B-18 A "Unified" Trial to Compare Short, Intensive Preoperative Systemic Adriamycin-Cyclophosphamide Therapy with Similar Therapy Administered in Conventional Postoperative Fashion
B-19 A Clinical Trial to Compare Sequential Methotrexate, 5-Fluorouracil (M → F) with Conventional CMF in Primary Breast Cancer Patients with Negative Nodes and Estrogen-Receptor-Negative Tumors
B-20 A Clinical Trial to Determine the Worth of Chemotherapy and Tamoxifen over Tamoxifen Alone in the Management of Patients with Primary Invasive Breast Cancer, Negative Axillary Nodes and Estrogen-Receptor-Positive Tumors
B-21 A Clinical Trial to Determine the Worth of Tamoxifen and the Worth of Breast Radiation in the Management of Patients with Node-Negative, Occult, Invasive Breast Cancer Treated by Lumpectomy
B-22 A Clinical Trial to Evaluate Dose Intensification and Increased Cumulative Dose on Disease-Free Survival and Survival of Primary Breast Cancer Patients with Positive Axillary Nodes Receiving Postoperative Adriamycin-Cyclophosphamide (AC) Therapy
B-23 A Clinical Trial Comparing Short, Intensive AC ± Tamoxifen with Conventional CMF ± Tamoxifen in Node-Negative Breast Cancer Patients with ER-Negative Tumors
B-24 A Clinical Trial to Evaluate the Worth of Tamoxifen in Conjunction with Lumpectomy and Breast Irradiation for the Treatment of Noninvasive Intraductal Carcinoma (DCIS) of the Breast
B-25 A Clinical Trial to Evaluate the Effect of Dose Intensification and Increased Cumulative Dose of Postoperative Adriamycin-Cyclophosphamide (AC) Therapy With G-CSF on the Disease-Free Survival and Survival of Patients With Primary Breast Cancer and Positive Axillary Nodes
B-26 A Randomized Trial in Patients with Metastatic or Locally Advanced Breast Cancer Comparing the Effect of 3-Hour vs 24-Hour Infusion of High-Dose Taxol
B-27 A Randomized Trial Comparing Preoperative Doxorubicin (Adriamycin) Cyclophosphamide (AC) to Preoperative AC Followed by Preoperative Docetaxel (Taxotere) and to Preoperative AC followed by Postoperative Docetaxel in Patients with Operable Carcinoma of the Breast
B-28 A Randomized Trial Comparing the Worth of Paclitaxel (Taxol) Following Doxorubicin (Adriamycin) /Cyclophosphamide in Breast Cancer Patients With Positive Axillary Nodes
B-29 A Clinical Trial to Evaluate the Benefit of Adding Octreotide (SMS 201-995 PA LAR) to Tamoxifen Alone or Tamoxifen and Chemotherapy in Patients with Axillary Node-Negative, Estrogen-Receptor-Positive, Primary Invasive Breast Cancer
B-30 A Three-Arm Randomized Trial To Compare Adjuvant Adriamycin And Cyclophosphamide Followed By Taxotere (AC6T); Adriamycin And Taxotere (AT); And Adriamycin, Taxotere, And Cyclophosphamide (ATC) In Breast Cancer Patients With Positive Axillary Lymph Nodes
B-31 A Randomized Trial Comparing The Safety And Efficacy Of Adriamycin And Cyclophosphamide Followed By Taxol (AC6T) To That Of Adriamycin And Cyclophosphamide Followed By Taxol Plus Herceptin (AC6T + H) In Node-Positive Breast Cancer Patients Who Have Tumors That Overexpress HER2
B-32 A Randomized, Phase III Clinical Trial To Compare Sentinel Node Resection To Conventional Axillary Dissection In Clinically Node-Negative Breast Cancer Patients
B-33 A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy
B-34 A Clinical Trial Comparing Adjuvant Clodronate Therapy vs. Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Tamoxifen or No Therapy
B-35 A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma In Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy
B-36 A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients With Node-Negative Breast Cancer
B-37 A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer
B-38 A Phase III, Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide Followed by DD Paclitaxel (DD AC → P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC → PG)
B-39 A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
B-40 A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens
B-41 A Randomized Phase III Trial of Neoadjuvant Therapy for Patients with Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered with Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response
B-42 A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer
B-49 A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
BP-59 Bone Marrow Analysis in Early-Stage Breast Cancer
C-01 A Clinical Trial to Evaluate Postoperative Immunotherapy and Postoperative Systemic Chemotherapy in the Management of Resectable Colon Cancer
C-02 A Protocol to Evaluate the Postoperative Portal Vein Infusion of 5-Fluorouracil and Heparin in the Management of Patients with Resectable Adenocarcinoma of the Colon
C-03 A Clinical Trial to Compare Adjuvant Leucovorin and 5-FU (LV+5FU) with Adjuvant MeCCNU, Vincristine and 5-FU (MOF), in Patients with Dukes' B and C Carcinoma of the Colon
C-04 A Clinical Trial to Assess the Relative Efficacy of 5-FU + Leucovorin, 5-FU + Levamisole, and 5-FU + Leucovorin + Levamisole in Patients with Dukes' B and C Carcinoma of the Colon
C-05 A Clinical Trial to Assess the Relative Efficacy of 5-FU + Leucovorin with or without Interferon Alfa-2a in Patients with Dukes' B and C Carcinoma of the Colon.
C-06 A Clinical Trial Comparing Oral Uracil/Ftorafur (UFT) Plus Leucovorin (LV) With 5­Fluorouracil (5­FU) Plus LV In The Treatment Of Patients With Stages II And III Carcinoma Of The Colon
C-07 A Clinical Trial Comparing 5-Fluorouracil (5-FU) Plus Leucovorin (LV) And Oxaliplatin With 5-FU Plus LV For The Treatment Of Patients With Stages II And III Carcinoma Of The Colon
C-08 A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab For the Treatment of Patients With Resected Stages II and III Carcinoma of the Colon
C-09 A Phase III Clinical Trial Comparing Oxaliplatin, Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients with Resected or Ablated Liver Metastases from Colorectal Cancer
C-10 A Phase II Trial of 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) Chemotherapy Plus Bevacizumab for Patients with Unresectable Stage IV Colon Cancer and a Synchronous Asymptomatic Primary Tumor
C-11 A Phase III Study Evaluating the Role of Perioperative Chemotherapy in Patients with Potentially Resectable Hepatic Colorectal Metastases
R-01 A Clinical Trial to Evaluate Postoperative Radiation and Postoperative Systemic Chemotherapy in the Management of Resectable Rectal Carcinoma
R-02 A Protocol to Compare Adjuvant MeCCNU, Vincristine and 5-Fluorouracil (MOF), With and Without Radiation, to Adjuvant Leucovorin and 5-Fluorouracil (LV+5FU), With and Without Radiation, in Patients with Dukes' B and C Carcinoma of the Rectum
R-03 A Clinical Trial to Evaluate the Worth of Preoperative Multimodality Therapy (5FU+LV+RTX) in Patients with Operable Carcinoma of the Rectum
R-04 A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum


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Prevention Trials Closed to Accrual

P-1 A Clinical Trial to Determine the Worth of Tamoxifen for Preventing Breast Cancer
P-2 (STAR) The Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
P-3 (PPP) Celecoxib Polyp Prevention Trial in Participants with Resected Stage I Colon Cancer
P-5 Statin Polyp Prevention Trial in Patients with Resected Colon Cancer


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