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Metastatic Breast Trials - Portfolio Map Key Acronym/Shortened Title A Phase II Clinical Trial in Patients with BRCA defective Tumours (6MP) Full Title Phase II Clinical Trial of 6-Mercaptopurine(6MP)and low-dose Methotrexate In Patients With Known BRCA Defective Tumours (FIRST LINE) Abiraterone Acetate in Advanced or Metastatic Breast Cancer A Cancer Research UK Phase I/II Open Label Study to Evaluate the Activity of Abiraterone Acetate in Oestrogen (ER) or Androgen Receptor (AR) Positive Advanced or Metastatic Breast Carcinoma (SECOND LINE) ARISTACAT Aromatase inhibition +/- saracatinib as advanced breast cancer therapy (FIRST/SECOND LINE) IRIS A Phase II study to assess the safety and efficacy of the steroid sulfatase inhibitor Irosustat in combination with aromatase inhibition in ER positive locally advanced or metastatic breast cancer patients (SECOND LINE) LANTERN A randomised phase II screening trial with functional imaging and patient reported toxicity sub-studies comparing Lapatinib plus capecitabine versus continued Trastuzumab plus capecitabine after local therapy in patients with ERb B2 positive metastatic breast cancer developing brain metastases (SECOND/THIRD LINE) NCRN096 - PHEREXA A multicenter randomized phase II study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (SECOND LINE) NCRN175 - AZD4547 + Exemestane in ER+ Breast Ca Pts with FGFR1 Polysomy A Randomised Double-blind Phase IIa Study (with Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination with Exemestane vs. Exemestane Alone in ER+ Breast Cancer Patients with FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment with One Prior Endocrine Therapy (Adjuvant or First-line Metastatic) (FIRST/SECOND LINE) NCRN186 A Phase III trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first-line therapy in postmenopausal subjects with hormone receptor positive, HER2-positive metastatic breast cancer (MBC) who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting (FIRST LINE) NCRN213 - Afatinib in HER2+ breast ca pts An open-label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the failing HER2-targeted treatment in the neoadjuvant and/or adjuvant treatment setting (FIRST/SECOND LINE) neoadjuvant/adjuvant setting April 2013 Acronym/Shortened Title Full Title Randomized, Open-Label Study of Abiraterone Acetate (JNJ‑212082) Alone or in Combination with Exemestane in NCRN220 - Abiraterone +/- exemestane in Postmenopausal Women with ER+ Metastatic Breast Cancer Progressing during or after Letrozole or Anastrozole ER+ MBC Therapy (FIRST/SECOND LINE) NCRN276 - P13k inhibitor + trastuzumab in A phase Ib/II, open label, multi-centre study evaluating the safety and efficacy of BKM120 in combination with replapsing HER 2+ MBC, failing previous trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab trastuzumab (THIRD/FOURTH LINE) A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of p38 MAPK Inhibitor plus Tamoxifen versus NCRN 279 Tamoxifen for Post-menopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer / I1D-MC-JIAF (THIRD LINE) A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in NCRN296 Women with Metastatic Breast Cancer (FIRST/SECOND LINE) NCRN335 NCRN354/Peruse – pert+tras+taxane NCRN365 A randomized, multicenter, open-label phase II trial investigating pertuzumab and trastuzumab plus an aromatase inhibitor in first-line patients with hormone receptor- and HER2-positive metastatic breast cancer A multicenter, open-label, single-arm study of a pertuzumab-based treatment regimen (pertuzumab in combination with trastuzumab and a taxane) in first line patients with HER2- positive advanced (metastatic or locally advanced) breast cancer A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients with gBRCA Mutation Breast Cancer or Other Solid Tumor NCRN378e An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects with Advanced Solid Tumors or with B-cell Malignancies and in Combination with Temozolomide (TMZ) or with Carboplatin and Paclitaxel in Subjects with Advanced Solid Tumors NCRN381 A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor- Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy NCRN391 NCRN 396 AN OPEN LABEL MULTICENTER PHASE 2 WINDOW OF OPPORTUNITY STUDY EVALUATING GANETESPIB (STA-9090) MONOTHERAPY IN WOMEN WITH PREVIOUSLY UNTREATED METASTATIC HER2 POSITIVE OR TRIPLE NEGATIVE BREAST CANCER An open-label, phase II study of vemurafenib in patients with BRAF V600 mutation-positive cancers April 2013 Acronym/Shortened Title Full Title NCRN402 The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine NCRN407 A randomized, double-blind, placebo controlled, phase II study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation NCRN409 A phase III randomized study, double blind placebo controlled of Fulvestrant in combination with oral BKM120 versus Fulvestrant plus Placebo, in the treatment of postmenopausal women with ER-positive, HER2-negative, mTORi-naive, locally-advanced or metastatic Breast Cancer (BC) refractory to Aromatase Inhibitor (AI). (BELLE 2) NCRN437 A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of bevacizumab, and associated biomarkers, in combination with paclitaxel compared with paclitaxel plus placebo as first-line treatment of patients with HER2-negative metastatic breast cancer NCRN454 A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor positive HER2 negative AI treated, locally advanced or metastatic breast cancer which progressed on or after mTOR inhibitor based treatment (BELLE3) NCRN463 Multicenter, single arm study of trastuzumab emtansine (T-DM1) in HER2 positive locally advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatment NCRN494 NCRN521 NCRN522 Exploratory open label study of GM-CSF coding oncolytic adenovirus CGTG-102, with low dose cyclophosphamide. Part I in patients with refractory injectable solid tumours; Part II in soft tissue sarcoma, breast cancer and melanoma / Oncos C236 A Phase IV multicentre, open label study of postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer treated with everolimus (RAD001) in combination with exemestane, with exploratory epigenetic marker analysis/CRAD001YGB11 A PHASE II, RANDOMIZED STUDY OF PACLITAXEL WITH GDC-0941 VERSUS PACLITAXEL WITH PLACEBO IN PATIENTS WITH LOCALLY RECURRENT OR METASTATIC BREAST CANCER April 2013 Acronym/Shortened Title Full Title NCRN548 An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer (BOLERO 4) NCRN550 A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole (BOLERO 6) NCRN565 Eribulin (HALAVEN®) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry RADICAL, v1.0 A randomised phase IIa study (with combination safety run in) to assess the safety and efficacy of AZD4547 in combination with either anastrozole or letrozole versus exemestane alone in ER positive breast cancer patients who are progressing on current treatment with anastrozole or letrozole PARP BRCA TNT A Cancer Research UK Phase II Proof of Principle Trial of the activity of the intravenous PARP-1 inhibitor, AG014699, in known carriers of a BRCA 1 or BRCA 2 mutation with locally advanced or metastatic breast or advanced ovarian cancer (SECOND LINE) Triple Negative Breast Cancer Trial: A randomised phase III trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced ER-, PR- and HER2- or known BRCA1 or BRCA2 mutation associated breast cancer (FIRST/SECOND LINE) April 2013