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Breast Cancer Clinical Trials

In set-up

PYTHIA: Phase II study of palbociclib plus fulvestrant versus placebo plus fulvestrant for pre-treated patients with ER+/HER2- metastatic breast cancer.

Open to recruitment

AURORA: Aiming to understand the molecular aberrations in metastatic breast cancer.

PALLET: A phase II randomised study evaluating the biological and clinical effects of the combination of palbociclib with letrozole as neoadjuvant therapy in post menopausal women with ER+ primary breast cancer.

PENELOPE-B: Phase III study evaluating palbociclib, a cyclin-dependent kinase 4/6 inhibitor, in patients with hormone receptor-positive, HER2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy.

plasmaMATCH: A multiple parallel cohort, open-label, multicentre phase IIa clinical trial aiming to provide proof of principle efficacy for designated targeted therapies in patients with advanced breast cancer where the targetable mutation is identified through ctDNA screening.

PRIMETIME: Post-operative avoidance of radiotherapy: biomarker selection of women categorised to be in a very low risk group by IHC4+C

RIO: Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer.

UNIRAD: Randomized, double-blind, multicentre phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with high risk of relapse, ER+ and HER2- primary breast cancer who remain free of disease after receiving at least 1 year of adjuvant hormone therapy.

In active follow-up

ABC: The NCRI Adjuvant Breast Cancer (ABC) International Trial: polychemotherapy and ovarian suppression in women with early breast cancer prescribed 5 years of tamoxifen.

AZURE: Does adjuvant zoledronic acid reduce recurrence in patients with high risk localised breast cancer?

BASO DCIS II: Randomised trial testing observation (no radiotherapy) against radiotherapy in women with low-risk completely excised ER positive ductal carcinoma in situ (DCIS) of the breast on adjuvant endocrine therapy.

DCIS II: Randomised trial testing observation (no radiotherapy) against radiotherapy in women with low-risk completely excised ER positive ductal carcinoma in situ (DCIS) of the breast on adjuvant endocrine therapy.

EPHOS-B: EPHOS-B (Effect of Perioperative AntiHER-2 therapy on Early Breast Cancer Study - Biological Phase) is a Phase III, multicentre, three arm, randomised controlled trial.

FAST Forward: Randomised clinical trial testing a 1-week course of curative whole breast radiotherapy against a standard 3-week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer.

FAST: A prospective randomised clinical trial designed to test 5 fractions of 5.7 Gy and 6.0 Gy against 25 fractions of 2.0 Gy in terms of late  normal tissue effects and tumour control in women prescribed whole breast radiotherapy (no boost) after local excision of early breast cancer.

HERA: The primary aim of the study is to compare disease-free survival (DFS) in patients with HER2 over expressing primary breast cancer randomised to Herceptin ® for 1 year or no further therapy or to Herceptin ® for 2 years or no further therapy. The trial recruited 5102 women with primary breast cancer that overexpresses HER2 (determined by IHC 3+ or FISH positive). Following the positive results at the interim analysis, all HERA patients on the observation arm have been offered the chance of receiving Herceptin treatment either for 1 year by direct assignment or by randomisation to either 1 or 2 years treatment, or they can choose to remain on the observation arm.

HOT: Randomised phase II trial of hyperbaric oxygen therapy for patients with chronic arm lymphoedema after radiotherapy for early breast cancer.

IMPORT HIGH: IMPORT HIGH - Randomised trial testing dose escalated intensity modulated radiotherapy (IMRT) for women treated by breast conservation surgery and appropriate systemic therapy for early breast cancer.

IMPORT LOW: Randomised trial testing intensity modulated and partial organ radiotherapy following breast conservation surgery for early breast cancer.

POETIC: POETIC is a randomised phase III multicentre trial in postmenopausal women with ER/PgR positive invasive breast cancer.

REACT: REACT is a multicentre, placebo controlled, randomised phase III trial in patients with primary breast cancer. Patients, in addition to their standard adjuvant therapy, are randomised between two years celecoxib (a COX-2 inhibitor) and placebo in a 2:1 ratio in favour of celecoxib.

SOFEA: A study of faslodex with or without concomitant arimidex versus exemestane following progression on non-steroidal aromatase inhibitors.

START: The national Standardisation of Radiotherapy (START) Trial in breast cancer was launched in January 1999 and aimed to identify the optimal regimen in terms of tumour control, late normal tissue effects and patient-reported quality of life, and to standardise routine radiotherapy treatments throughout the NHS for women with early breast cancer.

TACT: A randomised trial of standard anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (Epi-CMF) versus FEC followed by sequential docetaxel in women with early breast cancer.

TACT2: TACT2 is an NCRI Phase III randomised controlled trial of adjuvant chemotherapy in patients with early breast cancer.

TEXT: A phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine responsive breast cancer.

Triple Negative breast cancer Trial (TNT): TNT is 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 BRCA 2 mutation associated breast cancer.

TOPIC II: Trial of primary medical therapy for breast cancer.

UK HRT: National randomised trial of Hormone Replacement Therapy (HRT) in women with a history of early stage breast cancer.

Closed to recruitment

ACTION : Adjuvant Cytotoxic Chemotherapy in Older Women (ACTION) is an NCRI Phase III randomised controlled trial testing the benefit and tolerability of adjuvant chemotherapy in patients aged 70 and over with early stage ER negative or ER weakly positive breast cancer.

DEVA: A multicentre randomised trial of sequential epirubicin and docetaxel versus epirubicin in node positive postmenopausal breast cancer patients.

ICCG FEC Trial: Two randomised trials comparing CMF vs FEC in node positive and node negative primary breast cancer.

ICCG High Dose Study: Randomised trial of high dose therapy using cyclophosphamide, thiotepa and carboplatin in primary breast cancer patients with 4 or more histologically involved positive nodes.

ICCG HMFEC Trial: FE 50 C versus FE 75 C with or without sequential hormone therapy in women with node positive premenopausal breast cancer.

ICCG Neocent trial: Neocent is a multi-centre randomised, parallel group, comparative phase III neo-adjuvant study of chemotherapy versus endocrine therapy in postmenopausal patients with strongly ER positive primary breast cancer in whom it is felt cytoreductive pre-operative systemic therapy is indicated.

IES: The Intergroup Exemestane Study (IES) is a randomised double-blind trial in postmenopausal women with primary breast cancer who have received adjuvant tamoxifen for 2-3 years, comparing subsequent adjuvant exemestane treatment with further tamoxifen to complete a total of 5 years endocrine therapy.

QUEST: The QUEST trial comprises two phase III randomised controlled multicentre trials, conducted in parallel, to assess the impact of the type (Trial A) and timing (Trial B) of latissimus dorsi (LD) breast reconstruction on the quality of life of women following mastectomy for early breast cancer.

MAPLE: Double-blind short term pre-surgical study to assess the Molecular Antiproliferative Predictors of Lapatinib’s Effects in Breast Cancer.

SOFT: SOFT is a phase III, randomised, multicentre study evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for pre-menopausal women with endocrine responsive breast cancer.

TOPIC I: Trial of primary infusional chemotherapy.

TRAFIC: Trial of adjuvant 5FU infusional chemotherapy.
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