Age of menopause among women who remain premenopausal following treatment for early breast cancer: Long-term results from International Breast Cancer Study Group Trials V and VI

2007 ◽  
Vol 43 (11) ◽  
pp. 1646-1653 ◽  
Author(s):  
Ann Partridge ◽  
Shari Gelber ◽  
Richard D. Gelber ◽  
Monica Castiglione-Gertsch ◽  
Aron Goldhirsch ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Long Term Results ◽  
Study Group ◽  
Cancer Study ◽  
Cancer Study Group ◽  
Breast Cancer Study

scholarly journals Second non-breast primary cancer following adjuvant therapy for early breast cancer: A report from the International Breast Cancer Study Group

2009 ◽  
Vol 45 (4) ◽  
pp. 561-571 ◽  
Author(s):  
Lorenzo Gianni ◽  
Shari Gelber ◽  
Alberto Ravaioli ◽  
Karen N. Price ◽  
Ilaria Panzini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Early Breast Cancer ◽  
Study Group ◽  
Primary Cancer ◽  
Cancer Study ◽  
Cancer Study Group ◽  
Breast Cancer Study

scholarly journals Low-Dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor–Negative Early Breast Cancer: International Breast Cancer Study Group Trial 22-00

2016 ◽  
Vol 34 (28) ◽  
pp. 3400-3408 ◽  
Author(s):  
Marco Colleoni ◽  
Kathryn P. Gray ◽  
Shari Gelber ◽  
István Láng ◽  
Beat Thürlimann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Hormone Receptor ◽  
Low Dose ◽  
Phase Iii ◽  
Study Group ◽  
Cancer Study ◽  
Node Positive ◽  
Cancer Study Group ◽  
Breast Cancer Study

Purpose To evaluate the benefit of low-dose cyclophosphamide and methotrexate (CM) maintenance, which previously demonstrated antitumor activity and few adverse effects in advanced breast cancer, in early breast cancer. Patients and Methods International Breast Cancer Study Group (IBCSG) Trial 22-00, a randomized phase III clinical trial, enrolled 1,086 women (1,081 intent-to-treat) from November 2000 to December 2012. Women with estrogen receptor– and progesterone receptor–negative (< 10% positive cells by immunohistochemistry) early breast cancer any nodal and human epidermal growth factor receptor 2 status, were randomly assigned anytime between primary surgery and 56 days after the first day of last course of adjuvant chemotherapy to CM maintenance (cyclophosphamide 50 mg/day orally continuously and methotrexate 2.5 mg twice/day orally on days 1 and 2 of every week for 1 year) or to no CM. The primary end point was disease-free survival (DFS), which included invasive recurrences, second (breast and nonbreast) malignancies, and deaths. Results After a median of 6.9 years of follow-up, DFS was not significantly better for patients assigned to CM maintenance compared with patients assigned to no CM, both overall (hazard ratio [HR], 0.84; 95% CI, 0.66 to 1.06;P = .14) and in triple-negative (TN) disease (n = 814; HR, 0.80; 95% CI, 0.60 to 1.06). Patients with TN, node-positive disease had a nonstatistically significant reduced HR (n = 340; HR, 0.72; 95% CI, 0.49 to 1.05). Seventy-one (13%) of 542 patients assigned to CM maintenance did not start CM. Of 473 patients who received at least one CM maintenance dose (including two patients assigned to no CM), 64 (14%) experienced a grade 3 or 4 treatment-related adverse event; elevated serum transaminases was the most frequently reported (7%), followed by leukopenia (2%). Conclusion CM maintenance did not produce a significant reduction in DFS events in hormone receptor–negative early breast cancer. The trend toward benefit observed in the TN, node-positive subgroup supports additional exploration of this strategy in the TN, higher-risk population.

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