Phase II interventional study (N0337) of capecitabine in combination with vinorelbine and trastuzumab for first- or second-line treatment of HER2-positive metastatic breast cancer: A north central cancer treatment group trial

Clinical Breast Cancer

Volumn 12, Issue 2, 2012, Pages 81-86

  Tan, Winston W ^a   Allred, Jacob B ^b   Salim, Muhammad ^c   Flynn, Patrick ^d   Fishkin, Paul A S ^e   Stella, Philip J ^f   Wiesenfeld, Martin ^g   Bernath, Albert M ^h   Fitch, Tom R ⁱ   Perez, Edith A ^a  

^a MAYO CLINIC   (United States)

^b MAYO CLINIC   (United States)

^c SASKATCHEWAN CANCER AGENCY   (Canada)

^d Metro Minnesota Community Clinical Oncology Program   (United States)

^e Illinois Oncology Research Association   (United States)

^f Michigan Cancer Research Consortium   (United States)

^g Cedar Rapids Oncology Project   (United States)

^h GEISINGER MEDICAL CENTER   (United States)

ⁱ MAYO CLINIC   (United States)

Author keywords

Capecitabine; Combination chemotherapy; Metastatic breast cancer; Trastuzumab; Vinorelbine

Indexed keywords

CAPECITABINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; NAVELBINE; TRASTUZUMAB;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BONE PAIN; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CONSTIPATION; DEHYDRATION; DESQUAMATION; DIARRHEA; DRUG RESPONSE; DYSPNEA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; INJECTION SITE REACTION; LEUKOPENIA; METASTASIS; MOTOR DYSFUNCTION; MUCOSA INFLAMMATION; MULTICENTER STUDY; MYALGIA; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PROTEINURIA; RASH; SIDE EFFECT; SOMATOSENSORY DISORDER; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

EID: 84858988873     PISSN: 15268209     EISSN: 19380666     Source Type: Journal    
DOI: 10.1016/j.clbc.2012.01.001     Document Type: Article

References (26)

1. Livingston RB, Ellis GK, Gralow JR, et al. Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1997; 15:1395-400. (Pubitemid 27167371)
2. Fumoleau P, Delgado FM, Delozier T, et al. Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 1993; 11:1245-52. (Pubitemid 23199126)
3. Blum JL, Jones SE, Buzdar AU, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1999; 17:485-93. (Pubitemid 29075232)
4. O'Shaughnessy J, Miles D, Vukelja S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20:2812-23. (Pubitemid 34651510)
5. Burstein HJ, Kuter I, Campos SM, et al. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 2001; 19:2722-30. (Pubitemid 32441378)
6. Jahanzeb M, Mortimer JE, Yunus F, et al. Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2(+) metastatic breast cancer. Oncologist 2002; 7:410-7. (Pubitemid 35266133)
7. Chan A, Untch M, Petruzelka L, et al. Multinational phase II study of Navelbine (N) and Herceptin (H) as first-line therapy for HER2-overexpressing metastatic breast cancer (HER2+ MBC). Breast Cancer Res Treat 2002; 76 Suppl 1:S112.
8. Pegram MD, Konecny GE, O'Callaghan C, et al. Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer. J Natl Cancer Inst 2004; 96:739-49. (Pubitemid 38771819)
9. Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol 2005; 23:4265-74. Epub; 2005, May 23.
10. Esteva FJ, Valero V, Booser D, et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20:1800-8. (Pubitemid 34273269)
11. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92:205-16.
12. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344:783-92. (Pubitemid 32222155)
13. Spielmann M, Dorval T, Turpin F, et al. Phase II trial of vinorelbine/doxorubicin as first-line therapy of advanced breast cancer. J Clin Oncol 1994; 12:1764-70. (Pubitemid 24349375)
14. Dieras V, Extra JM, Bellissant E, et al. Efficacy and tolerance of vinorelbine and fluorouracil combination as first-line chemotherapy of advanced breast cancer: results of a phase II study using a sequential group method. J Clin Oncol 1996;14:3097-104. (Pubitemid 26408802)
15. Romero Acuña L, Langhi M, Pérez J, et al. Vinorelbine and paclitaxel as first-line chemotherapy in metastatic breast cancer. J Clin Oncol 1999; 17:74-81. (Pubitemid 29022380)
16. Fumoleau P, Fety R, Delecroix V, et al. Docetaxel combined with vinorelbine: phase I results and new study designs. Oncol Williston Park 1997; 11Suppl 6:29-31.
17. Nole F, Catania C, Mandala M, et al. Phase I study of vinorelbine (V) and capecitabine (C) in advanced breast cancer (ABC). Breast Cancer Res Treat 2000; 64:125.
18. Welt A, Von Minckwitz G, Borquez D, et al. Extended phase I study of capecitabine in combination with vinorelbine in pretreated patients with metastatic breast cancer. Breast Cancer Res Treat 2002; 76 Suppl 1:S90.
19. Ghosn M, Kattan J, Farhat F, et al. Navelbine (N) capecitabine (C) combination (Navcap): the new first line chemotherapy regimen for metastatic breast cancer (MBC): results of phase II trial. Breast Cancer Res Treat 2002; 76 Suppl 1:S133.
20. Bartsch R, Wenzel C, Altorjai G, et al. Capecitabine and trastuzumab in heavily pretreated metastatic breast cancer. J Clin Oncol 2007; 25:3853-8. (Pubitemid 47477260)
21. von Minckwitz G, du Bois A, Schmidt M, et al. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a German breast group 26/breast international group 03-05 study. J Clin Oncol 2009; 27:1999-2006.
22. Schaller G, Fuchs I, Gonsch T, et al. Phase II study of capecitabine plus trastuzumab in human epidermal growth factor receptor 2 overexpressing metastatic breast cancer pretreated with anthracyclines or taxanes. J Clin Oncol 2007; 25:3246-50. (Pubitemid 47325608)
23. Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006; 355:2733-43. Erratum in: N Engl J Med 2007; 356:1487. (Pubitemid 46021510)
24. Blackwell KL, Pegram MD, Tan-Chiu E, et al. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol 2009; 20:1026-31.
25. Chan A, Ganju V, Becquart D, et al. Efficacy of oral vinorelbine (NVBo), capecitabine (X) and trastuzumab (H) triple combination (NVBoXH) in HER-2 positive metastatic breast cancer (MBC): first results of an international phase II trial. J Clin Oncol 2007; 25 Suppl:45s.
26. Infante JR, Yardley DA, Burris HA 3rd, et al. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast Cancer 2009; 9:23-8.