Breast Cancer DataMart (BCDM)

BCDM Proposal Submission Form (right-click to save) Introduction Data available Instructions to Investigators/FAQs Contacts Introduction Back to top Data sharing, which makes possible meta-analysis at the level of the standardized data element, is a potentially powerful tool in breast cancer research. The NCI-supported cooperative groups of North America have recognized that the mining of shared data can be made even more powerful by asking more specific questions regarding therapy and breast cancer subtypes. The Breast Cancer Intergroup of North America (TBCI), the National Surgical Adjuvant Breast and Bowel Project (NSABP), and the International Breast Cancer Study Group (IBCSG) have elected to share electronic data files in order to allow for the study of specific questions that could not be addressed within a single trial's data set. Breast Cancer DataMart (BCDM) provides a data-mining capability that should allow more contemporaneous and frequent analyses of pooled breast cancer research data from the contributing cooperative groups in order to keep pace with the relatively frequent and rapid advances now being made in breast cancer research. Instructions to Investigators/FAQs Back to top What is Breast Cancer DataMart (BCDM)? What clinical trial data sets are available in the BCDM? Is BCDM under the jurisdiction of an IRB? What is the process for submitting a proposal to BCDM? What is the review process? What are the components of the data use agreement? Who are the main contact people for the BCDM? What is Breast Cancer DataMart (BCDM)? Back to FAQs Breast Cancer DataMart is a central warehouse of breast cancer clinical trial and correlative data pooled from North American and international breast cancer studies, currently housed at the NCI Center for Bioinformatics (NCICB). It allows for data sharing and collaborative data mining from a variety of breast cancer studies, within the limits of a pre-specified set of business rules and serves as an adjunct to the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) Oxford Overview mechanism. Is BCDM under the jurisdiction of an IRB? Back to FAQs The BCDM has IRB approval from Emory University to serve as a data repository for de-identified breast cancer clinical trial data. All approved proposals will be required to obtain local IRB approval (or waiver) prior to the release of data. What is the process for submitting a proposal to BCDM? Back to FAQs An investigator who wishes to answer a specific set of research questions through data-mining of one or more of the Groups’ studies pooled within BCDM must make a formal request to the BCDM Scientific Review Committee by submitting a proposal using the BCDM Proposal Form (right-click on the link to save form). Proposals should be submitted to the BCDM Steering Committee via email to pio@ctep.nci.nih.gov, with cc to zujewski@nih.gov. The committee accepts only electronic submissions. What is the review process? Back to FAQs The BCDM Scientific Review committee will conduct an internal review of the merit and feasibility of the proposal, including whether or not there are sufficient data to provide adequate information for the analysis, and the availability of the required data. Investigators will be notified of the Committee’s decisions in writing. If approved, release of the data will be contingent on IRB approval or waiver. In addition, a formal data use agreement covering the relevant conditions will be required. What are the components of the data use agreement? Back to FAQs The data use agreement requires that the data be used solely for the purpose approved, be kept confidential, and reports of the research findings submitted to the BCDM project. Who are the main contact people for the BCDM? Back to FAQs Inquiries regarding new ideas for studies should be directed to: William Wood, M.D. Chair, Breast Cancer DataMart Steering Committee Email: patti_long@emoryhealthcare.org Proposals should be submitted to: Email: pio@ctep.nci.nih.gov, with cc to zujewski@nih.gov Only electronic submissions are accepted. Summary of data available from BCDM Trials Back to FAQs Basic descriptors of DataMart clinical trials.xls Treatment descriptors of DataMart clinical trials, including regimen details.xls PLEASE NOTE: "Treatment descriptors" spreadsheet allows only one filter at a time on "Yes" indicators. Clinical trial data are available from the following DataMart trials. Variables include the following: Outcomes, including distant recurrence, local recurrence, vital status, and sites of second malignancy Hormone receptor status Age and menopausal status Axillary node status Tumor size and laterality Treatment Surgery Protocol No. Title Actual Accrual CALGB-7581 Long term surgical adjuvant systemic chemotherapy with or without adjuvant immunotherapy in mammary carcinoma CMF: 150 pts CMFVP: 166 pts CMF + MER: 85 pts CALGB-8082 Surgical Adjuvant Chemotherapy of stage II Breast Carcinoma: two-CMFVP regimens with or without a subsequent Adriamycin combination 945 CALGB-8541 Adjuvant CDF for Pathologic stage II, Node + Breast Cancer: Randomization among intensive CDF for four months vs. low dose CDF for four months vs. standard dose CDF for six months 1,572 CALGB-9082 (INT-0163) A Randomized, Comparative Study of High Dose CPA/CDDP/BCNU and ABMS Versus Standard Dose CPA/CDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Stage II or III Breast Cancer Involving > 10 Axillary Lymph Nodes or More 785 randomized CALGB-9343 Evaluation of Lumpectomy, Tamoxifen, & Irradiation of the Breast Compared with Lumpectomy + Tamoxifen in Women 70 Years of Age or Older who have Carcinoma of the Breast that is Less Than or Equal to 2cm & Clinically Negative Axillary Nodes 636 randomized CALGB-9344 (INT-0148) Doxorubicin dose escalation, with or without Taxol, as part of the ca adjuvant chemotherapy regimen for node positive Breast cancer: a Phase III intergroup trial 3,121 randomized C9741 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 2,005 E1178 (EST-1178) Adjuvant therapy with Tamoxifen vs. placebo in older (> 65 yrs) postmenopausal patients with stage II Breast cancer 170 randomized E1180 (INT-0011/EST-1180) Evaluation of adjuvant therapy and biological parameters in node negative operable female Breast cancer Randomized: CMFP: 273 Observation: 263 (536 total, with 425 analyzable) Registry of ER+ < 3 cm pts (not sent to DataMart): 632 (453 analyzable) E2190 (EST-2190, INT-0121) A Phase III study of conventional adjuvant Chemotherapy vs. high dose Chemo. & auto. BMT as adj. intensification therapy following conventional adj. Chemotherapy in patients with stage II & III Breast cancer at high risk of recurrence 540 (511 eligible) E3181 (EST-3181) Management of resectable locally advanced primary Breast cancer 426 registered, 332 of those randomized, 312 of those analyzed E3189 (INT-0108/EST-3189) Phase III comparison of cyclophosphamide, doxorubicin, and 5-fluorouracil (caf) and a 16-week multi-drug regimen as adjuvant therapy for patients with hormone receptor negative, node-positive Breast cancer 646 E4181 (EST-4181) Adjuvant therapy for postmenopausal women with Breast cancer (CTX, MTX,5-FU, Pred, Tam) 962 (803 eligible, 802 assessable); 87 postmeno re-rand to continued tam E5177 (EST-5177) An adjuvant clinical trial to compare Cytoxan, MTX, 5-FU (CMF) to CMF and Prednisone (CMFP) with or without Tamoxifen in premenopausal women with stage II Breast cancer 662 (553 assessable) E5181 (EST-5181) Phase III an adjuvant clinical trial to compare cmfpt to alternating Cmf(p)th and Thiotepa, Adriamycin, Vinblastine, Halotestin and short- versus long-term Tamoxifen in premenopausal pts. with operable n+ Breast cancer 658 (533 assessable) 478 in continue or stop tam after chemo completion 107 in continued or stop tam after 5 years E5188 (INT-0101) Phase III comparison of combination CHEMOTHERAPY (CAF) and CHEMOHORMONAL Therapy (CAF + ZOLADEX or CAF + ZOLADEX + TAMOXIFEN) in Premenopausal Women with Axillary Node-Positive Receptor-Positive BREAST CANCER 1,536 (1,503 eligible) E6177 (EST-6177) A clinical trial to compare adjuvant therapy with Cytoxan, Mtx, 5-FU and Prednisone (CMFP) versus CMFP and Tamoxifen versus no adjuvant therapy in post-menopausal patients with stage II Breast cancer 265 (223 assessable) EB193 (INT-0151) Phase III double-blind, placebo-controlled, prospective randomized comparison of adjuvant therapy with Tamoxifen vs. Tamoxifen and Fenretinide in postmenopausal women with involved axillary lymph nodes and positive receptors. 426 IBCSG-10-93 Phase III Randomized Study of Surgery With or Without Axillary Node Clearance Followed By Adjuvant Tamoxifen in Elderly Women With Breast Cancer 473 patients randomized (234 to Sx + Ax, 239 to Sx) IBCSG-11-93 Phase III Randomized Study of Adjuvant Ovarian Ablation and Tamoxifen Maintenance with vs without 4 Courses of Anthracycline/Cyclophosphamide (AC) in Premenopausal Women with Node-Positive Breast Cancer Suitable for Endocrine Therapy Alone 174 randomized IBCSG-12-93 Phase III Randomized Study of Adjuvant Endocrine Therapy (Tamoxifen Vs Toremifene) With Vs Without Anthracycline/Cyclophosphamide (AC) in Peri- and Postmenopausal Women With Node-Positive Breast Cancer, With Chemotherapy Started Either Concurrently With or Prior to Endocrine Therapy 450 randomized IBCSG-13-93 Phase III Randomized Study of Adjuvant Anthracycline and Cyclophosphamide and Cyclophosphamide, Methotrexate, and Fluorouracil with vs without a 16-Week Treatment Free Interval Between Regimens and with vs without Subsequent Tamoxifen in Premenopausal Women with Node Positive Breast Cancer Unsuitable for Endocrine Therapy Alone 1,246 randomized IBCSG-14-93 Phase III Randomized Study of Adjuvant Anthracycline/Cyclophosphamide and Cyclophosphamide/Methotrexate/Fluorouracil with vs without a 16-Week Treatment-Free Interval Between Regimens and with Subsequent Tamoxifen vs Toremifene in Peri- and Postmenopausal Women with Node-Positive Breast Cancer Unsuitable for Endocrine Therapy Alone 969 randomized IBCSG-15-95 Phase III Randomized Study of Adjuvant High-Dose Combination Chemotherapy With Peripheral Blood Stem Cell and G-CSF Support Vs Adjuvant Sequential Standard Dose Combination Chemotherapy for Pre- and Postmenopausal Women Younger Than 66 Years With High-Risk, Operable, Stage II/III Breast Cancer 344 randomized IBCSG-I Search for optimal adjuvant therapies, combining hormone and chemotherapy, in operable breast cancers. Schema I: Pre & Peri menopausal 1-3N+ 491 eligible (505 randomized) IBCSG-II Search for optimal adjuvant therapies, combining hormone and chemotherapy, in operable breast cancers. Schema II: Pre & Peri menopausal 4 or more N+ 327 eligible (356 randomized) IBCSG-III Search for optimal adjuvant therapies, combining hormone and chemotherapy, in operable breast cancers. Schema III: Post menopausal all N+, 65 years or less 463 eligible (503 randomized) IBCSG-IV Search for optimal adjuvant therapies, combining hormone and chemotherapy, in operable breast cancers. Schema IV: Post menopausal all N+, 66 years up to 80 years 320 eligible (349 randomized) IBCSG-IX Phase III Randomized Study of Adjuvant Cyclophosphamide/Methotrexate/Fluorouracil (CMF) Followed by Tamoxifen vs Tamoxifen Alone in Postmenopausal Women with Operable, Node-Negative Breast Cancer 1,669 eligible (1,708 randomized) IBCSG-VI Phase III Randomized Study of Adjuvant Chemotherapy with CMF (CTX/MTX/5-FU) with vs without Subsequent Reinduction in Pre- and Peri-Menopausal Patients with Operable Breast Cancer 1,475 eligible (1505 randomized) IBCSG-VII Phase III Randomized Study of Adjuvant Hormonal Therapy with TAM with vs without Chemotherapy with CMF (CTX/MTX/5-FU) in Postmenopausal Patients with Operable Breast Cancer 1,212 eligible (1,235 randomized) IBCSG-VIII Phase III Study of Adjuvant Therapy in Pre- and Perimenopausal Women with Node-Negative Breast Cancer: Cyclophosphamide/Methotrexate/Fluorouracil (CMF) vs Goserelin vs Sequential CMF and Goserelin 1,109 randomized (1,063 excluding no treatment group) IBSCG-V Perioperative and conventionally timed chemotherapy in operable breast cancer 2,504 eligible (2,628 randomized) Mayo-70-56-32 An Evaluation of Surgical Adjuvant Chemotherapy Utilizing 5-Fluorouracil, Cytoxan, and Prednisone With or Without Radiation Therapy Versus Phenylalanine Mustard in Patients With Operable But Prognostically Unfavorable Breast Cancer 328 NCCTG-77-30-51 An evaluation of surgical adjuvant therapy in women with operable primary breast cancer at high risk for recurrence 729 NCCTG-89-30-52 Phase III Trial of Adjuvant Therapy with Tamoxifen Alone or Combined with Fluoxymesterone in Postmenopausal Women with Resected Estrogen Receptor Positive Breast Cancer 541 (514 eligible pts provided in DataMart) NCIC-MA.17 (JMA17) parent study (Parent study) A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen (NCIC CTG MA.17) 5,187 randomized NCIC-MA.4 Phase III Adjuvant Post-Surgical TMX vs TMX plus CMF (CTX/MTX/5-FU) in ER and/or PR(+) Postmenopausal Breast Cancer Patients with Histologically Involved Axillary Nodes 705 eligible NCIC-MA.5 Phase III Adjuvant Chemotherapy with Intensive CEF (CTX/EPI/5-FU) vs Standard CMF (CTX/MTX/5-FU) in Premenopausal Patients with Carcinoma of the Breast with Positive Axillary Nodes 710 eligible NSABP-B-04 Protocol for a Cooperative Study to Compare the Efficacy of Radical Mastectomy to That of Total Mastectomy with and without Irradiation in the Treatment of Cancer of the Female Breast 1,665 evaluable patients (1,079 cN-, 586 cN+) NSABP-B-06 A Protocol to Compare Segmental Mastectomy and Axillary Dissection with and without Radiation of the Breast and Total Mastectomy and Axillary Dissection 2,163 (1,851 evaluable) NSABP-B-13 A Clinical Trial to Assess Sequential MTX then 5-FU in Patients with Primary Breast Cancer and Negative Axillary Nodes Whose Tumors are Negative for Estrogen Receptors 760 randomized NSABP-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 2,892 randomized NSABP-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: < or = 49 Years - All Patients; 50-59 Years - PR < 10 fmol, Regardless of ER 2,338 NSABP-B-16 A 3 Arm Clinical Trial Comparing Tamoxifen Alone with L-PAM, 5-FU, Adriamycin & Tamoxifen or with Short Intensive Adria-Cycloposphamide & Tamoxifen in +Node PTS w/PR > 10fmol Regardless of ER, 60-70 yrs - All Patients 1,296 NSABP-B-17 A Clinical Trial to Evaluate Natural History and Treatment of Patients with Non-Invasive Intraductal Adenocarcinoma and Lobular In-Situ Registry (Radiotherapy versus not) 818 randomized NSABP-B-18 A "Unified" Trial to Compare Short Intensive Preoperative Systemic Adriamycin Cyclophosphamide Therapy with Similar Therapy Administered in Conventional Postoperative Fashion 1,523 NSABP-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 1,095 NSABP-B-20 A Clinical Trial to Compare Tamoxifen (TAM) with Sequential Methotrexate, 5-Fluorouracil and TAM (M-F+T) or CMF and TAM (CMF+T) in Patients with Primary Breast Cancer, Negative Axillary Nodes and Estrogen Receptor Positive Tumors 2,363 NSABP-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 1,009 NSABP-B-22 A Clinical Trial to Evaluate Dose Intensification and Increased Cumulative Dose on the Disease-free Survival of Primary Breast Cancer Patients with Positive Axillary Nodes Receiving Postoperative Adriamycin-Cyclophosphamide (AC) Therapy 2,305 NSABP-B-23 A Clinical Trial Comparing Short, Intensive AC + or - Tamoxifen with Conventional CMF + or - Tamoxifen in Node-Negative Breast Cancer Patients with ER-Negative Tumors 2,008 NSABP-B-24 A Clinical Trial to Evaluate the Worth of Tamoxifen in Conjunction with Lumpectomy and Breast Irradiation for the Treatment of Non-Invasive Intraductal Carcinoma (DCIS) of the Breast 1,804 NSABP-B-25 A Clinical Trial to Evaluate the Effect of Dose Intensification of Postoperative Adriamycin/CTX (AC) Therapy with G-CSF on the Disease-Free Survival and Survival of Patients with Primary Breast Cancer and Positive Axillary Nodes 2,548 S7436 (SWOG-7436) Combination chemotherapy (CMFVP) vs L-Phenylalanine mustard (L-Pam) for operable Breast Cancer with positive axillary nodes 441 S7827 (SWOG-7827) Combined modality therapy for Breast carcinoma, Phase III ~1,212 (of these, 314 were premenopausal; 898 were eligible postmenopausal) S8313 (SWOG-8313) Multiple drug adjuvant chemotherapy for patients with er negative stage ii carcinoma of breast 531 eligible pts to CMFVP vs. FAC-M S8814 (INT-0100) Phase III comparison of adjuvant chemoendocrine therapy with caf and concurrent or delayed tamoxifen to tamoxifen alone in postmeopausal patients with involved axillary lymph nodes and positive receptors 1,558 S8897 (INT-0102) Phase III comparison of adjuvant chemotherapy with or without endocrine therapy in high-risk, node negative Breast cancer patients, and a natural history follow-up study in low-risk, node negative patients 2,931 S9313 (INT-0137) Phase III comparison of adjuvant chemotherapy with high-dose cyclophosphamide plus doxorubicin (ac) versus sequential doxorubicin followed by cyclophosphamide (a-c) in high-risk node-negative Breast cancer patients 3,176 S9623 A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin plus Paclitaxel plus Cyclophosphamide with High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women with 4-9 Involved Axillary Lymph Nodes 602

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