Clinical Trial Results: Herceptin [trastuzumab]

Product Name: Herceptin [trastuzumab]
Date of Report: 10/11/2002
Phase: IV
Expanded access programme: treatment with Herceptin (trastuzumab) in patients with metastatic breast cancer (MBC) who overexpress HER2

Product Name: Herceptin [trastuzumab]
Date of Report: 9/15/2003
Phase: II
A Multicenter, Randomized Comparative Study on the Efficacy and Safety of Herceptin (Trastuzumab) Plus Docetaxel (Taxotere) Versus Docetaxel Alone as First Line Treatment in Patients with HER2-Positive Metastatic Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: 1/1/2004
Phase: II
A multicenter, open-label, single arm phase II study of safety and efficacy of a three-weekly regimen of Herceptin monotherapy in patients with HER2-overexpressing/amplification in metastatic breast cancer.

Product Name: Herceptin [trastuzumab]
Date of Report: 3/11/2004
Phase: II
Trastuzumab (Ro 45-2317) in combination with epirubicin and docetaxel as first-line chemotherapy in metastatic breast cancer patients

Product Name: Herceptin [trastuzumab]
Date of Report: 9/1/2004
Phase: II
Pharmacokinetic Study of Herceptin® (H) and Doxorubicin (A) plus Paclitaxel (T) followed by weekly Paclitaxel (AT+/-H→TH) in Women with Metastatic Breast Cancer and HER2 Overexpression.

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: III
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: IV
A Continuation Study of Herceptin (Trastuzumab) in Patients With Metastatic Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) in Women With c-erbB2–Positive Metastatic Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) in Combination Therapy in Patients with Metastatic Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) in Women With HER2-Positive Advanced and/or Metastatic Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: III
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients with Advanced Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: III
ToGA study A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A study of Xeloda (Capecitabine) and Herceptin (Trastuzumab) in Patients With Advanced or Metastatic Pancreatic Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: 10/3/2005
Phase: II
An open label randomised phase 2 study of trastuzumab (Herceptin) given with weekly paclitaxel (Taxol) versus weekly paclitaxel as single agent in first-line therapy for patients with HER-2/neu overexpressing advanced breast cancer (ABC).

Product Name: Herceptin [trastuzumab]
Date of Report: 1/1/2006
Phase: III
A randomized three-arm multi-center comparison of 1 year and 2 years of Herceptin® versus no Herceptin® in women with HER2-positive primary breast cancer who have completed adjuvant therapy.

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: II
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer

Product Name: Herceptin [trastuzumab]
Date of Report: 3/15/2006
Phase: II
An open-label pilot Phase II trial of Herceptin (trastuzumab) (humanized anti-HER2 antibody) administered as monotherapy in patients with HER2-overexpressing metastatic or locally advanced Transitional Cell Carcinoma of the Bladder (TCC)

Product Name: Herceptin [trastuzumab]
Date of Report: 7/3/2006
Phase: II
A phase II trial evaluating the administration of trastuzumab in combination with cisplatin-epirubicin-paclitaxel (PETH) in metastatic breast cancer patients.

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: IV
A PK-Loading Study of q3w Herceptin (Trastuzumab) Monotherapy in Women With HER2 Positive Metastatic Breast Cancer.

Product Name: Herceptin [trastuzumab]
Date of Report: 8/1/2006
Phase: III
A randomized, controlled, open-label study to evaluate the efficacy and safety of Herceptin® (trastuzumab) in combination with the oral aromatase inhibitor Arimidex® compared with Arimidex® alone as first line (and second line hormonal) treatment administered to post menopausal, hormone receptor positive (ER+ and/or PgR+) patients with HER2 overexpressing metastatic breast cancer.

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: III
A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

Product Name: Herceptin [trastuzumab]
Date of Report: To be Published
Phase: III
THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.