scholarly journals National Surgical Adjuvant Breast and Bowel Project (NSABP)

2006 ◽  
Vol 9 (S1) ◽  
pp. 402-411
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Ductal Carcinoma ◽  
Phase Iii ◽  
Partial Breast Irradiation ◽  
List Type ◽  
Breast Irradiation ◽  
National Surgical Adjuvant Breast ◽  
Bowel Project

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by National Surgical Adjuvant Breast and Bowel Project (NSABP). Clinical trials include: NSABP B-35 – A clinical trial comparing anastrozole with tamoxifen in postmenopausal patients with ductal carcinoma in situ (DCIS) undergoing lumpectomy with radiation therapy.NSABP 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.NSABP 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).NSABP 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.

scholarly journals Radiation Therapy Oncology Group (RTOG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 411-418
Author(s):  
Keyword(s):  
Clinical Trials ◽  
Radiation Therapy ◽  
Radiation Therapy Oncology Group ◽  
Phase Iii ◽  
Partial Breast Irradiation ◽  
List Type ◽  
Breast Irradiation ◽  
Oncology Group ◽  
Duct Carcinoma ◽  
Conformal Radiation Therapy

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Radiation therapy Oncology group (RTOG). Clinical trials include: RTOG 9804: Phase III trial of observation ± tamoxifen versus RT ± tamoxifen for good risk duct carcinoma in-situ(DCIS) of the female breast.NSABP B-39/RTOG 0413: 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.A phase II trial to evaluate three dimensional conformal radiation therapy (3D-RT) confined to the region of the lumpectomy cavity for stage I and II breast carcinoma.

scholarly journals Dutch Breast Cancer Trialists' Group (BOOG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 61-79
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Metastatic Breast ◽  
Phase Iii ◽  
List Type ◽  
First Line ◽  
Open Label ◽  
Phase Iii Study

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Dutch breast cancer trialists' group (BOOG). Clinical trials include:An open label randomized (inter)national multicenter comparative trial of 5 years adjuvant endocrine therapy with an LHRH agonist plus an aromatase inhibitor (goserelin + anastrozole) versus five courses FE90C chemotherapy followed by the same endocrine therapy in pre- or perimenopausal patients with hormone receptor-positive primary breast cancer (PRemenopausal Optimal Management IS Endocrine therapy). BOOG 2002-01/PROMISE. ISRCTN23561723Open label, comparative, randomized, multicenter, study of trastuzumab (Herceptin) given with docetaxel (Taxotere) versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for metastatic breast cancer (MBC) patients with HER2neu overexpression. BOOG 2002-02/HERTAX ISRCTN13770586Micro-metastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in BREAST CANCER. BOOG 2003-03/ZonMW 3214Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed. BOOG 2004-01/Young Boost SRCTN45066831Microarray analysis in breast cancer to Tailor Adjuvant Drugs Or Regimens, a randomized phase III study. MATADOR, BOOG 2005-02, CKTO 2004-04 ISRCTN61893718A prospective randomised, open, multicentre, phase III study to assess different Durations of Anastrozole therapy after 2–3 years Tamoxifen as Adjuvant therapy in postmenopausal women with breast cancer. 2006-01/DATAA randomized, open-label phase III study of first line chemotherapy in elderly metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a complete geriatric assessment. 2006-02/OMEGABOOG participation in International studies:. BOOG 2001-01/TEAM trial. BOOG 2001-02/AMAROS (EORTC 10981/22023). BOOG 2002-04/HERA (BIG 1-01/EORTC 10011/BO16348B). BOOG 2003-02 (BIG 1-02/IBCSG 27-02). BOOG 2003-04 (GBG 29). BOOG 2004-02/TBP (GBG 26, BIG 3-05). BOOG 2005-01/CASA (IBCSG 32-05/BIG 1-05). BOOG 2005-03/MINDACT (EORTC 10041, BIG 3-04). BOOG 2006-03/SUPREMO (BIG 2-04). BOOG 2006-04/Adjuvant lapatinib study (BIG 2-06/EGF106708)

scholarly journals Breast European Adjuvant Studies Team (BREAST)

2006 ◽  
Vol 9 (S1) ◽  
pp. 80-90
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Phase Iii ◽  
List Type ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Phase Iii Trial ◽  
Adjuvant Trial ◽  
Current Contact ◽  
Positive Breast Cancer

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Breast European Adjuvant Studies Team (BREAST). Clinical trials include: An intergroup phase III trial to evaluate the activity of docetaxel, given either sequentially or in combination with doxorubicin, followed by CMF, in comparison to doxorubicin alone or in combination with cyclophos-phamide, followed by CMF, in the adjuvant treatment of node-positive breast cancer patients. BIG 02-98/TAX 315HERA: A randomized three-arm multi-centre comparison of 1 year and 2 years of Herceptin versus no Herceptin in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy. BIG 01-01/B016348Adjuvant trial with lapatinib and trastuzumab* (BIG) *trial title/acronym not available at time of publication.

Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial

2020 ◽  
Vol 38 (35) ◽  
pp. 4175-4183 ◽  
Author(s):  
Icro Meattini ◽  
Livia Marrazzo ◽  
Calogero Saieva ◽  
Isacco Desideri ◽  
Vieri Scotti ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Phase Iii ◽  
Accelerated Partial Breast Irradiation ◽  
Long Term Results ◽  
Partial Breast Irradiation ◽  
Whole Breast Irradiation ◽  
Breast Irradiation ◽  
Once Daily

PURPOSE To report the long-term results of external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT) Florence phase III trial comparing whole-breast irradiation (WBI) to APBI in early-stage breast cancer. PATIENTS AND METHODS The primary end point was to determine the 5-year difference in ipsilateral breast tumor recurrence (IBTR) between 30 Gy in 5 once-daily fractions (APBI arm) and 50 Gy in 25 fractions with a tumor bed boost (WBI arm) after breast-conserving surgery. RESULTS Five hundred twenty patients, more than 90% of whom had characteristics associated with low recurrence risk, were randomly assigned (WBI, n = 260; APBI, n = 260) between 2005 and 2013. Median follow-up was 10.7 years. The 10-year cumulative incidence of IBTR was 2.5% (n = 6) in the WBI and 3.7% (n = 9) in the APBI arm (hazard ratio [HR], 1.56; 95% CI, 0.55 to 4.37; P = .40). Overall survival at 10 years was 91.9% in both arms (HR, 0.95; 95% CI, 0.50 to 1.79; P = .86). Breast cancer–specific survival at 10 years was 96.7% in the WBI and 97.8% in the APBI arm (HR, 0.65; 95% CI, 0.21 to 1.99; P = .45). The APBI arm showed significantly less acute toxicity ( P = .0001) and late toxicity ( P = .0001) and improved cosmetic outcome as evaluated by both physician ( P = .0001) and patient ( P = .0001). CONCLUSION The 10-year cumulative IBTR incidence in early breast cancer treated with external APBI using IMRT technique in 5 once-daily fractions is low and not different from that after WBI. Acute and late treatment-related toxicity and cosmesis outcomes were significantly in favor of APBI.

Patient-reported outcomes (PROs) in NRG oncology/NSABP B-39/RTOG 0413: A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) in stage 0, I, or II breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 508-508 ◽  
Author(s):  
Patricia A. Ganz ◽  
Reena S. Cecchini ◽  
Julia R. White ◽  
Frank Vicini ◽  
Thomas B. Julian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Outcomes ◽  
Pain Scale ◽  
Local Tumor Control ◽  
Phase Iii ◽  
Partial Breast Irradiation ◽  
Tumor Control ◽  
Breast Irradiation ◽  
Related Symptom ◽  
Patient Reported

508 Background: PBI is an alternative to WBI, with potentially greater therapy (tx) compliance, and better integration with chemotherapy (CTX). NSABP B-39/RTOG 0413 clinical outcome results from 2018 did not show equivalence of PBI to WBI in local tumor control; PBI was statistically inferior, but with clinically small differences. PBI may be an acceptable alternative to WBI for some women. Understanding cosmesis and quality of life (QOL) treatment outcomes is important. Methods: B-39/0413 included a prospective QOL substudy with PRO evaluation of breast cancer treatment outcomes (cosmesis, function, pain) and fatigue using BCTOS and SF-36 vitality scales. Secondary QOL parameters included treatment related symptoms, perceived convenience of care, and the BPI pain scale. The study sample was stratified by CTX or not, as CTX is given before WBI but after PBI. PRO assessments occurred before randomization, the last day of adjuvant tx [CTX or radiation], 4 wks later, and 6, 12, 24, and 36 mo later. Primary aims included comparisons of change in fatigue from baseline to end of tx and equivalency of change in cosmesis from baseline to 36 mo for PBI v WBI. Separate analyses were done for CTX and non-CTX pts, controlling for axillary dissection. Each comparison used α=0.0125. Planned sample size was 964. Results: From 3-23-05 to 5-27-09, 975 pts were enrolled in the PRO study; 950 had follow-up data. 504 did not receive CTX and 446 received CTX. In non-CTX pts, PBI had less fatigue (p=0.011) and did not meet criteria for cosmesis equivalence (97.5% CI, -0.02 to 0.22; ∆=0.20). In CTX pts, PBI had worse fatigue (p=0.011) and equivalent cosmesis to WBI (97.5% CI, -0.09 to 0.21; ∆=0.24). In both groups, PBI pts reported less pain at end of tx. In non-CTX pts, PBI had more pain at 36 mo but in CTX pts, there was no difference. Convenience of care and treatment related symptom outcomes will be presented. Conclusions: In non-CTX pts, PBI is more convenient with less fatigue and slightly poorer cosmesis at 36 mo. Cosmesis was equivalent at 36 mo in CTX pts. Support: U10CA180868, -180822, UG1CA189867. Clinical trial information: NCT00103181.

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