Ongoing Clinical Trials
List of Studies Open June 2011:
IBIS Prevention: International Breast cancer Intervention Study (IBIS) of anastrozole vs placebo in
postmenopausal women at increased risk of breast cancer – Prevention Study. (s & m)
IBIS-II (DCIS): International Breast cancer Intervention Study (IBIS) of tamoxifen vs. anastrozole in
postmenopausal women with Ductal Carcinoma In-Situ (DCIS) (s & m)
Circulating Mi RNAs: Novel Breast Cancer Biomarkers and their use for Guiding and monitoring
response to chemotherapy. (s & m)
NSABP B-46-1/USOR 07132: Phase 111 Clinical Trial Comparing the Combination of TC Plus
Bevacizumab tp TC Alone and to TAC for Women with Node-Positive or High-Risk Node-Negative, HER2Negative Breast Cancer. (medical)
Neo Adjuvant Study TCHL: A Phase 11 neo-adjuvant study assessing TCH (Docetaxel, Carboplatin and
Trastuzumab, TCL (Docetaxel, Carboplatin and Lapatinib) and the combination of TCHL (Docetaxel,
Carboplatin, Trastuzumab and Lapatinib) in ErbB2+ve breast cancer patients.
The CADY Study - Detection of Cardiac Dysfunction in Patients Treated with Trastuzumab for HER-2
Positive Breast Cancer (medical)
The Myocet/Lapatinib Study –ICORG 10-03.“A Phase 1/11 study of Lapatinib plus non-pegylated
liposomal doxorubicin in patients with HER2+ve metastatic breast cancer following disease progression
during, or after, treatment with Trastuzumab and Taxanes. (medical)
TRIO 012: Protocol No. IMCL CP12-0606. A Multicentre, Multinational, Randomized, Double-Blind,
Phase 111 Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated
Patients with HER2-Neg, Unresectable, Locally-Recurrent or Metastatic Breast Cancer. (medical)
TRIO 019 ICON Study No. 050/114. Protocol No. CRAD001J2301. A Randomized Phase 111,
Double-Blind, Placebo Controlled Multicentre Trials of Oral Everolimus in Combination with Trastuzumab
and Paclitaxel, as First Line Therapy in Women with HER2/NEU Overexpressing Locally Recurrent or
Metastatic Breast Cancer. (medical)
EGF114299: A Phase 111 trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an
aromatise inihibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first line therapy in
postmenopausal subjects with hormone receptor positive, HER-pos metastatic breast cancer (MBC) who
received trastuzumab and endocrine therapy in the neo/adjuvant setting (medical)
The Myocet/Lapatinib Study –ICORG 10-03. “A Phase 1/11 study of Lapatinib plus non-pegylated
liposomal doxorubicin in patients with HER2+ve metastatic breast cancer following disease progression
during, or after, treatment with Trastuzumab and Taxanes. (medical)
Radiation Oncology Studies:
The clinical Trials Department also runs studies under the guidance of the Radiation Oncologists:
Consultant Radiation Oncologists:
Dr
Dr
Dr
Dr
Joe Martin
Frank Sullivan
Cormac Small
Maeve Pomeroy
SUPREMO, an MRC phase 111 randomised trial to assess the role of adjuvant chest wall irradiation in
‘intermediate risk’ operable breast cancer following mastectomy.
NSABP Protocol B-39, RTOG Protocol 0413. A randomised Phase 3 study of Conventional Whole
Breast Irradiation (WBI) versus Partial Breast Irradiation (PBI) for women with Stage 0,1 or 2 Breast
Cancer.