| Protocol number | Participating Groups | Title | Study arms | Protocol Description (PDQ) | Specimens available for research | Years Active | Total patient accrual | P.I. |
|---|---|---|---|---|---|---|---|---|
| C9741 | CALGB (Lead), ECOG, NCCTG, SWOG | Phase III Randomized Study of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed By Paclitaxel at 14 and 21 Day Intervals in Women With Node Positive Stage II or IIIA Breast Cancer | Arm I: Sequential A, paclitaxel, C, Q3W
Arm II: Sequential A+ G-CSF, paclitaxel + G-CSF, C + G-CSF Q2W Arm III: Concurrent AC followed by paclitaxel Q3W Arm IV: Concurrent AC + G-CSF followed by paclitaxel + G-CSF Q2W Patients receive tamoxifen and RT post-chemo. |
Protocol Description (PDQ) | Specimens available for research | 1997-1999 | 2,005 | Dr. Marc Citron |
| CALGB-49907 | CALGB (Lead), ACOSOG, ECOG, GOG, NCCTG, NCIC CTG, NSABP, RTOG, SWOG | A Randomized Trial of Adjuvant Chemotherapy with Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil -(CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older with Node Positive or Node-Negative Breast Cancer |
Arm I, Group B (pts w/normal LVEF): AC Q3W x 4
Arm II: Capecitabine Q3W x 6 Following treatment, ER+/PR+ pts receive tamoxifen or aromatase inhibitor for 5 years, and breast conservation surgery pts undergo RT |
Protocol Description (PDQ) | Paraffin block of tumor | 2001-2006 | 623 as of late Nov 2006 | Dr. Hyman Muss |
| CALGB-8944 (INT-0112) | CALGB (Lead), ECOG | Phase II Combined Modality Treatment of Patients with Stage III Adenocarcinoma of the Breast: Intensive ADR Chemotherapy Followed by Definitive Surgery, CMF, and Radiotherapy | Sequential Adriamycin, Surgery, CMF, Radiotherapy, and, for ER/PgR+,
Tamoxifen
(non-randomized) |
Protocol Description (PDQ) | 1990-1992 | 113 | Dr. David Duggan | |
| CALGB-9082 (INT-0163) | CALGB (Lead), SWOG, NCIC CTG | Phase III Randomized Comparison of High-Dose Chemotherapy with Autologous Marrow and Peripheral Stem Cell Support vs Standard-Dose Chemotherapy Following Adjuvant Chemotherapy in Women with Stage II/IIIA Breast Cancer with at Least 10 Positive Axillary Nodes | Arm I: Standard-dose chemo
Arm II: High-dose chemo followed by BMT and PBSCT |
Protocol Description (PDQ) | 1991-1998 | 1,036 | Dr. William Peters | |
| CALGB-9343 | CALGB (Lead), ECOG, RTOG | Phase III Randomized Study of Adjuvant Tamoxifen with vs without Radiotherapy Following Lumpectomy for Carcinoma of the Breast No Greater Than 2 cm with Clinically Negative Axillary Nodes in Women Age 70 and Over | Arm I: Tamoxifen
Arm II: Tamoxifen + Radiotherapy |
Protocol Description (PDQ) | Specimens available for research | 1994-1999 | 647 | Dr. Kevin Hughes |
| CALGB-9344 (INT-0148) | CALGB (Lead), ECOG, NCCTG, SWOG | Phase III Randomized Study of Adjuvant CA (Cyclophosphamide/ Doxorubicin) Comparing Standard- vs Intermediate- vs High-Dose Doxorubicin, with vs without Subsequent Paclitaxel, in Women with Node-Positive Breast Cancer | Arm I: Standard-dose doxorubicin
Arm II: Medium-dose doxorubicin Arm III: High-dose doxorubicin Arm IV: Standard-dose doxorubicin followed by paclitaxel Arm V: Medium-dose doxorubicin followed by paclitaxel Arm VI: High-dose doxorubicin followed by paclitaxel |
Protocol Description (PDQ) | Specimens available for research | 1994-1997 | 3,170 | Dr. Isaac Henderson |
| E1193 | ECOG (Lead), NCCTG, SWOG | Phase II/III Randomized Trial of doxorubicin vs paclitaxel vs doxorubicin/paclitaxel/G-CSF in Patients with Metastatic Breast Cancer | Arm A: Doxorubicin
Arm B: Paclitaxel Arm C: Doxorubicin/ Paclitaxel/G-CSF |
Protocol Description (PDQ) | 1993-1995 | 736 | Dr. George Sledge | |
| E1199 | ECOG (Lead), CALGB, NCCTG, SWOG | Phase III Randomized Study of Doxorubicin and Cyclophosphamide Followed By Paclitaxel or Docetaxel in Women With Node-Positive or High-Risk Node-Negative Stage II or IIIA Breast Cancer | Arm I: AC followed by paclitaxel 3 hrs Q3W X4
Arm II: AC followed by paclitaxel 1 hr Q1W X12 Arm III: AC followed by docetaxel 1 hr Q3W X4 Arm IV: AC followed by docetaxel 1 hr Q1W X12 |
Protocol Description (PDQ) | Specimens available for research | 1999-2002 | 5,052 | Dr. Joseph Sparano |
| E2100 | ECOG (Lead), CALGB, GOG, NCIC CTG, NSABP, NCCTG, RTOG, SWOG | Phase III Randomized Study of Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer | Arm I: Paclitaxel followed by bevacizumab
Arm II: Paclitaxel |
Protocol Description (PDQ) | Specimens available for research | 2002-2004 | 722 | Dr. Kathy Miller |
| E2190 (INT-0121) | ECOG (Lead), CALGB, SWOG | Phase III Randomized Study of Adjuvant CAF (Cyclophosphamide/ Doxorubicin/Fluorouracil) vs Adjuvant CAF Followed by Intensification with High-Dose Cyclophosphamide/Thiotepa plus Autologous Stem Cell Rescue in Women with Stage II/III Breast Cancer At High Risk of Recurrence | Arm I: CAF
Arm II: CAF followed by cyclophos./thiotepa + BM or PBSC rescue |
Protocol Description (PDQ) | Specimens available for research | 1991-1998 | 540 | Dr. Martin Tallman |
| E2197 | ECOG (Lead), CALGB, NCCTG, SWOG | Phase III Randomized Study of Doxorubicin/Docetaxel versus Doxorubicin/ Cyclophosphamide as Adjuvant Treatment for Node Positive or High Risk Node Negative Breast Cancer | Arm I: Doxorubicin + Docetaxel
Arm II: Doxorubicin + Cyclophosphamide |
Protocol Description (PDQ) | Specimens available for research | 1998-2000 | 2,952 | Dr. Lori Goldstein |
| E3193 (INT-0142) | ECOG (Lead Group), CALGB, NCCTG, SWOG | Phase III Randomized Study of Adjuvant Tamoxifen with vs without Ovarian Ablation in Premenopausal Women with Axillary Node-Negative Receptor-Positive Breast Cancer 3 cm or Less in Diameter | Arm I: Tamoxifen
Arm II: Tamoxifen + Ovarian albation |
Protocol Description (PDQ) | Specimens available for research | 1994-1997 | 345 | Dr. Nicholas Robert |
| E5188 (INT-0101) | ECOG (Lead), CALGB, SWOG | Phase III Randomized Comparison of Adjuvant Therapies in Premenopausal Women with Resected Node-Positive Hormone Receptor-Positive Adenocarcinoma of the Breast: CAF vs CAF Followed by Zoladex vs CAF Followed by Zoladex/Tamoxifen | Arm I: CAF
Arm II: CAF followed by Goserelin Arm III: CAF followed by Goserelin + Tamoxifen |
Protocol Description (PDQ) | Specimens available for research | 1989-1994 | 1,536 | Dr. Nancy Davidson |
| E5194 | ECOG (Lead), NCCTG | Screening Study Following Local Excision in Selected Patients with Ductal Carcinoma in Situ (DCIS) of the Breast | (screening following local excision) | Protocol Description (PDQ) | Specimens available for research | 1997-2002 | 711 | Dr. Lorie Hughes |
| E-EB193 (INT-0151) | ECOG (Lead), CALGB, NCCTG, SWOG | Phase III Randomized Study of Adjuvant Tamoxifen/Fenretinide vs Tamoxifen/Placebo in Postmenopausal Women with Receptor-Positive Breast Cancer | Arm I: Tamoxifen/fenretinide
Arm II: Tamoxifen/placebo |
Protocol Description (PDQ) | Specimens available for research | 1995-1999 | 426 | Dr. Melody Cobleigh |
| E-PBT01 | ECOG (Lead), NCCTG, PBTG, SWOG | Phase III Randomized Comparison of Conventional CMF Maintenance vs High-Dose Combination Chemotherapy plus Autologous Bone Marrow and Peripheral Stem Cell Rescue in Women with Metastatic Breast Cancer Responding to Conventional Induction Chemotherapy | Induction:
CAF, or CMF +/- prednisone Post-induction: Arm I: high-dose cyclophosphamide, thiotepa, and carboplatin followed by rescue with autologous bone marrow and/or peripheral stem cells + GM-CSF Arm II: standard-dose CMF |
Protocol Description (PDQ) | 1994-1997 | 553 | Dr. Edward Stadtmauer | |
| EST-1180 (INT-0011) | ECOG (Lead), CALGB, SWOG | Phase III Adjuvant Chemotherapy with CMFP (CTX/MTX/5-FU/PRED) and Evaluation of Biological Parameters in Node-Negative Operable Female Breast Cancer | Arm I: CMFP (Cyclophosphamide, Methotrexate, 5-Fluorouracil,
Prednisone)
Arm II: Observation |
Protocol Description (PDQ) | Specimens available for research | 1981-1988 | 1,224 | Dr. Edward Mansour |
| EST-3189 (INT-0108) | ECOG (Lead), SWOG | Phase III Randomized Comparison of CAF vs a 16-Week Multi-Drug Regimen (Cyclophosphamide, Doxorubicin, Vincristine, Methotrexate, 5-Fluorouracil) as Adjuvant Therapy in Node-Positive Patients with Receptor-Negative Breast Cancer | Arm I: CAF Cyclophosphamide, Doxorubicin, 5-Fluorouracil
Arm II: Cyclophosphamide, Doxorubicin, Vincristine, Methotrexate, 5-Fluorouracil + Leucovorin Rescue Regimen A: Radiotherapy (less than total mastectomy) |
Protocol Description (PDQ) | 1989-1993 | 646 | Dr. John Fetting | |
| N9831 | NCCTG (Lead), CALGB, ECOG, NCIC CTG, SWOG | Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel with or without Trastuzumab as Adjuvant Treatment for Women with HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer |
Arm I: AC, followed by paclitaxel
Arm II: AC, followed by paclitaxel, followed by trastuzumab Arm III: AC, followed by paclitaxel, followed by paclitaxel and trastuzumab, followed by trastuzumab All receptor+ pts receive tamoxifen or A.I.; selected pts may undergo RT |
Protocol Description (PDQ) | Specimens available for research | 2000 | 3,505 | Dr. Edith Perez |
| NCIC-JMA17 | NCIC CTG (Lead), BIG, CALGB, ECOG, EORTC, NCCTG, SWOG | Phase III Randomized Study of Letrozole Versus Placebo in Postmenopausal Women With Primary Breast Cancer Who Have Completed at Least Five Years of Adjuvant Tamoxifen | Arm I: Letrozole (following = 5 yrs tamoxifen)
Arm II: Placebo (following = 5 yrs tamoxifen) |
Protocol Description (PDQ) | Specimens available for research | 1998-2002 | 5,187 | Dr. Paul Goss |
| NCIC-MA.20 | NCIC CTG (Lead), CALGB, ECOG, NCCTG, NSABP, RTOG, SWOG | A Phase III Study of Regional Radiation Therapy in Early Breast Cancer | Arm I: standard breast radiotherapy (RT) alone 5 days/week x 5
Arm II: breast + regional RT 5 days/week x 5 RT initiated w/in 8 weeks following adjuvant chemo completion unless concurrent, or w/in 16 weeks following last surgery for hormonal-therapy-alone pts. |
Protocol Description (PDQ) | Paraffin block of tumor | 2002-2007 | 1,829 | Dr. Timothy Whelan |
| NCIC-MA.21 | NCIC CTG (Lead), CALGB, ECOG, NCCTG, NSABP, RTOG, SWOG | A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who have had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer | Arm I: CEF Q4W x 6
Arm II: EC + G-CSF Q2W x 6 + epoetin alpha weekly followed by paclitaxel + G-CSF Q3W x 4 + epoetin alpha weekly Arm III: AC Q3W x 4 followed by paclitaxel Q3W x 4 ER+/PR+ pts receive tamoxifen or anastrozole for 5 years after chemo completion |
Protocol Description (PDQ) | Specimens available for research | 2002 | 2,104 | Dr. Margot Joy Burnell |
| NCIC CTG-MA.27 | NCIC CTG (Lead), ACOSOG, CALGB, ECOG, GOG, NCCTG, NSABP, RTOG, SWOG | A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer | Arm I: Oral exemestane for 5 years
Arm II: Oral anastrozole for 5 years |
Protocol Description (PDQ) | Paraffin block of tumor; frozen tumor (virtual bank); blood at baseline and 6 months | 6,840 | 2003 | Paul Goss, MD |
| S9623 | SWOG (Lead), CALGB, ECOG, NCCTG | Phase III Randomized Study of Intensive Sequential Doxorubicin, Paclitaxel, and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed By STAMP I or STAMP V Combination Chemotherapy With Autologous Stem Cell Rescue in Women With Primary Breast Cancer and At Least 4 Involved Axillary Lymph Nodes | Arm I: Doxorubicin, paclitaxel, cyclophosphamide, + G-CSF
Arm II: Doxorubicin, cyclophosphamide + harvest of autologous bone marrow or PBSC; followed by STAMP I (cyclophosphamide, cisplatin, carmustine) or STAMP V(cyclophosphamide, carboplatin, thiotepa), followed by transplantation tamoxifen daily and locoregional radiotherapy |
Protocol Description (PDQ) | Specimens available for research | 1996-2001 | 602 | Dr. Scott Bearman |
| S9927 | SWOG (Lead), ACOSOG, CALGB, ECOG, NCCTG, NCIC CTG, NSABP, RTOG | Phase III Randomized Study of Radiotherapy After Mastectomy and Adjuvant Chemotherapy and/or Hormonal Therapy in Women With Stage II Breast Cancer With One to Three Positive Nodes | Arm I: Radiotherapy
Arm II: Observation |
Protocol Description (PDQ) | Specimens available for research | 2000-2003 | 98 | Dr. Lori Pierce |
| SWOG-8692 (INT-0075) | SWOG (Lead), ECOG, NCCTG | Phase III Randomized Comparison of Surgical Oophorectomy vs Medical Oophorectomy with Goserelin in Premenopausal Women with Metastatic, ER-Positive or PR-Positive Carcinoma of the Breast | Arm I: oophorectomy
Arm II: goserelin, with selected patients receiving oophorectomy |
Protocol Description (PDQ) | 1987-1995 | 138 | Dr. William Dalton | |
| SWOG-8814 (INT-0100) | SWOG (Lead), CALGB, ECOG, NCIC CTG, NCCTG | Phase III Randomized Comparison of Adjuvant Therapy with Tamoxifen vs CAF plus Concurrent or Delayed Tamoxifen in Postmenopausal Women with Node- and Receptor-Positive Breast Cancer | Arm I: Tamoxifen
Arm II: CAF followed by tamoxifen Arm III: CAF plus concurrent tamoxifen Regimen A: Radiotherapy (lumpectomy) Regimen B: Radiotherapy (selected mastectomy pts) |
Protocol Description (PDQ) | Specimens available for research | 1989-1995 | 1,558 | Dr. Kathy Albain |
| SWOG-8897 (INT-0102) | SWOG (Lead), CALGB, ECOG | Phase III Randomized Comparison of Adjuvant Chemotherapy with CMF vs CAF with vs without Long-Term Endocrine Therapy with Tamoxifen in High-Risk Node-Negative Breast Cancer Patients and a Natural History Follow-Up Study in Low-Risk Node-Negative Patients | Low-risk pts (by ER status, S phase, tumor size) assigned to:
Arm 0: Observation / natural history (arm discontinued in 1991) High-risk pts (by ER status, S phase, tumor size) randomized to: Arm I: CMF Arm II: CAF Arm III: CMF --> Tamoxifen Arm IV: CAF --> Tamoxifen (Breast-sparing surgery pts: RT prior to or after chemo) |
Protocol Description (PDQ) | Specimens available for research | 1989-1993 | 4,406 | Dr. Laura Hutchins |
| SWOG-9115 (INT-0127) | SWOG (Lead), ECOG | Phase III Randomized Comparison of Marrow Ablation with STAMP V and Autologous Stem Cell Rescue vs Standard Chemotherapy in Patients with Poor-Prognosis Advanced Breast Carcinoma | Arm A: Continuation of induction
Chemotherapy only
Arm B: STAMP V: (Cyclophosphamide, Thiotepa, Carboplatin) followed by autologous bone marrow or PBSC transplant Regimen A: Tamoxifen (ER+) |
Protocol Description (PDQ) | 1992-1994 | 41 | Dr. Robert Livingston | |
| SWOG-9313 (INT-0137) | SWOG (Lead), CALGB, ECOG, NCCTG | Phase III Randomized Study of Adjuvant Chemotherapy with High-Dose Doxorubicin/ Cyclophosphamide (AC) vs Doxorubicin Followed by Cyclophosphamide (A-C) in Women with High-Risk Breast Cancer and 0-3 Positive Nodes | Arm I: AC q3w x 6 + G-CSF (--> tamoxifen for 5 yrs for ER+)
Arm II: A q3w x 4 --> C q2w x 3 + G-CSF (--> tamoxifen for 5 yrs for ER+) |
Protocol Description (PDQ) | Specimens available for research | 1994-1998 | 3,176 | Dr. Charles Haskell |