Breast Cancer Clinical Trials

Editor
Neil Love, MD

Contributing Editor
C Kent Osborne, MD

Faculty  
George W Sledge Jr, MD
Norman Wolmark, MD
Clifford Hudis, MD
Julie R Gralow, MD
John F R Robertson, MD
Edith A Perez, MD

Editor’s Note:
Let’s get this thing done.

Prologue:
The adjuvant trastuzumab clinical research to practice model
- Select publications

Breast Cancer Clinical Trials:
A compendium of ongoing and proposed clinical trials in the neoadjuvant,
adjuvant and metastatic settings

Neoadjuvant Therapy
1. What is the optimal aromatase inhibitor for neoadjuvant therapy? ACOSOG-Z1031
2. What is the optimal neoadjuvant therapy for women with HER2-negative breast cancer? NSABP-B-40
Radiation Therapy
3. Does partial breast irradiation (PBI) provide equivalent local tumor control compared to whole breast irradiation (WBI) following lumpectomy? NSABP-B-39
Adjuvant Endocrine Therapy
4. What is the optimal adjuvant endocrine therapy for postmenopausal women with DCIS? IBIS-II (DCIS)/NSABP-B-35
5. What is the optimal duration of adjuvant aromatase inhibitor therapy? NSABP-B-42
6. Which is the safest and most efficacious aromatase inhibitor as up-front adjuvant therapy for postmenopausal women? CFEM345D2411
7. What is the optimal adjuvant endocrine therapy for premenopausal patients?
SOFT/TEXT/PERCHE
Adjuvant Chemotherapy
8. Which adjuvant bisphosphonate is most effective at preventing metastases?
SWOG-S0307
9. What is the utility of adjuvant chemotherapy for patients with intermediate recurrence scores of the Oncotype DX™ assay? TAILORx
10. Is oral, single-agent capecitabine as effective as standard adjuvant AC or CMF in older patients? CALGB-49907
11. What is the optimal chemotherapy regimen for patients with lower-risk node-positive or node-negative disease? CALGB-40101/NSABP-B-36
12. What is the optimal adjuvant chemotherapy regimen for patients with node-positive or higher-risk node-negative disease? SWOG-S0221
13. What is the optimal adjuvant chemotherapy regimen for patients with node-positive disease? NSABP-B-38
14. Is it safe to combine bevacizumab with dose-dense adjuvant chemotherapy? ECOG-E2104
15. Is bevacizumab a safe and effective treatment for residual disease after preoperative chemotherapy? NCT00121134
Metastatic Disease
16. What is the optimal endocrine therapy for postmenopausal patients with metastases and disease progression on a nonsteroidal aromatase inhibitor? SoFEA/SWOG-S0226/FACT
17. What is the optimal dosing of fulvestrant for postmenopausal patients? CONFIRM
18. Does lapatinib improve outcomes when combined with trastuzumab in patients with HER2-positive metastatic disease? EGF104383/EGF104900
19. Does bevacizumab add benefit to endocrine therapy for metastatic disease? CALGB-40503 (proposed)
20. Can HER2 and ER cross-talk be therapeutically exploited by combining fulvestrant and trastuzumab? UCLA-0502057-01
21. What is the benefit of adding bevacizumab to chemotherapy as first- and second-line therapy? RIBBON 1/RIBBON 2
Future Trial Concepts
Study Contacts

CME Test Online

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