Download Metastatic Breast Trials - Portfolio Map Key

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