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The Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU)

Published online by Cambridge University Press:  04 December 2006

Abstract

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by The Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU). Clinical trials include:

  1. The NCRI Adjuvant Breast Cancer (ABC) trial. ISRCTN31514446

  2. The UK randomized trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer. ISRCTN29941643

  3. NCRI Standardisation of Breast Radiotherapy (START) trial. ISRCTN59368779

  4. TACT: A randomized trial of standard anthracycline-based chemotherapy (fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (Epi-CMF)) versus FEC followed by sequential docetaxel in women with early breast cancer. ISRCTN 79718493

  5. SoFEA: Study of Faslodex with or without concomitant Arimidex versus Exemestane following progression on non-steroidal Aromatase inhibitors. ISRCTN: 44195747

  6. TACT2: Trial of accelerated adjuvant chemotherapy with Capecitabine in early breast cancer. ISRCTN68068041

  7. FAST trial: Prospective randomized clinical trial testing 5.7 Gy and 6.0 Gy fractions of whole breast radiotherapy in terms of late normal tissue responses and tumour control.

  8. IMPORT low trial.

  9. IMPORT high trial.

  10. Adjuvant chemotherapy in older women (ACTION).

ICR-CTSU – Contact Details

Country

United Kingdom

Head

J. Bliss, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, 15 Cotswold Road, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 208 722 4297 Fax: +44 208 770 7876 Email:

Deputy Head

E. Hall, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, 15 Cotswold Road, Sutton SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 208 722 4292 Fax: +44 208 770 7876 Email:

ICR-CTSU – Study Details

Title

The NCRI Adjuvant Breast Cancer (ABC) trial.

ISRCTN31514446

Coordinator(s)

J. Yarnold, Royal Marsden Hospital NHS Trust, Downs Road, Sutton, SURREY SM2 5PT, UNITED KINGDOM. Tel: +44 20 8661 3891 Fax: +44 20 8661 3107 Email:

Deidre Price, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, 15 Cotswold Road, Sutton SURREY SM2 5NG, UNITED KINGDOM. Email:

Summary

  • Opened in January 1993; closed in September 2000

Objective

  • To test whether adjuvant chemotherapy (CT) and/or ovarian suppression (OS) add to the benefits of tamoxifen in pre/perimenopausal women with early breast cancer.

Scheme

Substudies

  • Biological predictors of therapeutic response
  • Quality of life

Update

  • Study closed; 3854 patients recruited (2144 pre/perimenopausal patients randomized to ±OS*, 637 pre/perimenopausal patients randomized to ±CT* and 1354 postmenopausal patients randomized to ±CT. Total of 1991 patients randomized to ±CT). Results were presented at ASCO 2004, and at several UK meetings. Manuscripts are in preparation. Recently received additional funding for translational research from BCC and CRUK for two studies – one to study p53 as a predictive response to CT and another to study markers for tamoxifen early versus late relapse.

Related publications

None available

Topics

  • Tamoxifen
  • Ovarian suppression
  • Postmenopausal patients
  • Premenopausal patients

Keywords

None available

***************************************************

Title

The UK randomized trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer.

ISRCTN29941643

Coordinator(s)

J. Marsden, King's College Hospital NHS Trust, LONDON, UNITED KINGDOM.

C. Dawson, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, Cotswold Road, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 208 722 4373 Fax: +44 208 770 7876 Email:

Summary

  • Opened in March 2002; closed to recruitment in February 2004
  • Target accrual: 3000

Objectives

  • To assess the effect of HRT on disease-free survival and overall survival.
  • The relief of menopausal symptoms and quality of life.
  • Coronary heart disease, vascular events (i.e. thromboembolic, cere-brovascular) and osteoporotic fractures.

Scheme

HRT arm*: If hysterectomised: unopposed oestrogen

If intact uterus:

sequential combined therapy

continuous combined therapy

Choice and route of preparation will be determined by menopausal status and patient preference, where appropriate.

No-HRT arm – advice on:

practical measures

clonidine

evening primrose oil

health foods

complementary medicine (e.g.reflexology, acupuncture, massage, meditation)

Low dose progesterones and phyto-oestrogen supplements are not recommended.

In both arms: preparation available for use for vaginal dryness.

Update

  • 197 patients.

Related publications

None available

Topics

  • Hormone replacement therapy

Keywords

Early breast cancer, HRT

***************************************************

Title

NCRI Standardisation of Breast Radiotherapy (START) trial.

ISRCTN59368779

Coordinator(s)

J. Yarnold, Royal Marsden Hospital NHS Trust, Downs Road, Sutton, SURREY SM2 5PT, UNITED KINGDOM. Tel: +44 20 8661 3891 Fax: +44 20 8661 3107 Email:

M. Sydenham, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, Cotswold Road, Sutton, SURREY SM2 5PT, UNITED KINGDOM. Tel: +44 20 8722 4104 Fax: +44 20 8770 7876 Email:

Summary

  • Opened in January 1999; closed to recruitment in October 2002
  • Target accrual: 2010 in Trial A (=670 per arm); 1840 in Trial B (=920 per arm).

Objective

  • To test the effects of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of loco-regional tumour control, normal tissue responses, quality of life and economic consequences in women prescribed postoperative radiotherapy for early breast cancer.

Scheme

Update

  • Trial B closed to recruitment in October 2001 with a total of 2215 patients.
  • Trial A closed at the end of October 2002 with a total of 2236 patients.

Related publications

Brown J, Mills J, Haviland J, Bliss J, Yarnold J, on behalf of the START Trial Management Group. Productivity and health effects of radiotherapy in breast cancer patients. Poster presentation at the EORTC Economic Health Meeting, Brussels, September 2003 (Abstract published in European Journal of Cancer Supplements 2003; 1 (3): S10).

Mills J, Haviland J, Bliss J, Yarnold J, Hopwood P, on behalf of the START Trial Management Group. Quality of life (QL) assessment of anxiety and depression in the START trial for women with early breast cancer. Poster presentation at BOA, Manchester, 2003. Clinical Oncology 15 (6 Supplement 4): S32.

Mills J, Haviland J, Brown J, Hopwood P, Bliss J, Yarnold, J, on behalf of the START Trial Management Group. How soon do patients return to work after radiotherapy treatment for early stage breast cancer. Poster presentation at BOA, Edinburgh, 2004. Clinical Oncology 16 (6 Supplement 1): pS31.

Mills J, Brown J, Haviland J, Bliss J. How soon do patients return to paid and unpaid activities after radiotherapy treatment for early stage breast cancer in the START trial. Poster presentation at the British Psychosocial Oncology Meeting, Brighton, 2005.

Mills J, Moynihan C, Bliss J, Hopwood P. Quality of life in context: women's proffered comments on QL relate issues in early stage breast cancer. Poster presentation at NCRI Conference, Birmingham, 2005.

Mills J, Sumo G, Bliss J, Hopwood P. Changes in sexual functioning following treatment for early stage breast cancer in the START trial. Poster presentation at NCRI Conference, Birmingham, 2005.

Sydenham M, Haviland J, Bliss J, Venables K, Yarnold J, on behalf of the START Trial Management Group. Evaluation of the effect of the START (Standardisation of Breast Radiotherapy) trial on radiotherapy practice in the UK. Poster presentation at BOA, Edinburgh, 2004. Clin Oncol 16 (6 Supplement 1): pS31.

Venables K, Winfield E, Aird E, Hoskin P, on behalf of the START Trial Management Group. Three-dimensional distribution of radiation within the breast. An intercomparison of departments participating in the START trial of breast radiotherapy fractionation. Int J Radiat Oncol Biol Phys 2003; 55 (1): 271–279.

Venables K, Miles E, Deighton A, Aird E, Hoskin P, on behalf of the START Trial Management Group. Irradiation of the heart during tangential breast treatment: a study within the START trial. Br J Radiol 2004; 77 (914): 137–142.

Venables K, Winfield E, Aird E, Hoskin P, on behalf of the START Trial Management Group. The use of in vivo thermoluminescent dosimeters in the quality assurance programme for the START breast fractionation trial. Radiother Oncol 2004; 71: 303–310.

Venables K, Miles EA, Hoskin PJ, Aird EG, on behalf of the START Trial Management Group. Verification films: a study of the daily and weekly reproducibility of breast patient set-up in the START trial. Clin Oncol(R Coll Radiol) 2005; 17 (5): 337–342.

Venables K, Miles EA, Aird EG, Hoskin PJ, on behalf of the START Trial Management Group. What is the optimum breast plan? – A study based on the START trial plans. Br J Rad 2006 (accepted January 2006).

Winfield E, Deighton A, Venables K, Hoskin P, Aird E, on behalf of the START Trial Management Group. Survey of tangential field planning and dose distribution in the UK: background to the introduction of the quality assurance programme for the START trial in early breast cancer. Br J Radiol 2003; 76: 254–259.

Yarnold J, Sydenham M, Haviland J, Mills J, Bliss J, on behalf of the START Trial Management Group. Update of the START (Standardisation of Breast Radiotherapy) trial. Poster presentation at UKRO Meeting, April 2003.

Topics

  • Radiotherapy
  • Loco-regional relapse

Keywords

Radiotherapy, early breast cancer

***************************************************

Title

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

ISRCTN 79718493

Coordinator(s)

P. Ellis, Guy's, Kings, St Thomas' Cancer Centre, Medical Oncology Research Office, 3rd Floor, Thomas Guy House, St Thomas St., LONDON SE1 9RT, UNITED KINGDOM. Tel: +44 20 7955 5000 Fax: +44 20 7955 2714 Email:

P. Barrett-Lee, Velindre NHS Trust, Whitchurch, CARDIFF CF14 2TL, UNITED KINGDOM. Tel: +44 02920 316 914 Fax: +44 02920 316 267 Email:

J. Banerji, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, Cotswold Road, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 20 8722 4188 Fax: +44 20 8770 7876 Email:

Summary

  • Opened in February 2001; closed in July 2003
  • Target accrual: 3340 – increased to 4000 in January 2003, final accrual: 4162

Scheme

Update

  • In follow up: data collection has been streamlined to ensure release of outcome data as early as possible.
  • Quality of life (QL) study: 829 patients participated in the QL study. An additional QL assessment at 5 years is planned in order to evaluate long-term survivorship issues.
  • Biological studies: a collection of paraffin embedded tissue was completed, and tissue micro-arrays for over 3500 patients are in storage. A TRICC application for biological research is planned.
  • A collection of blood samples from consenting TACT trial patients is still ongoing, with over 3000 blood samples collected. This is conducted in collaboration with breakthrough breast cancer.

Related publications

Bartlett JMS, Mallon EA, Forsyth A, et al. for the Trial Management Groups of TEAM and TACT. HER2 differentially affects invasive potential in ER −ve and ER +ve breast cancers. JCO 2005; 23: 16S 9557 (poster) ASCO, 2005.

Barrett-Lee P, Bliss J, Ellis P, Hall E, Johnson L, Lawrence D, on behalf of the TACT Trial Management Group. Adjuvant taxanes for early breast cancer – clinical uncertainty exists. Br J Cancer 2001a; 85 (Suppl 1): 5.3 p20.

Barrett-Lee P, Bliss J, Ellis P, Hall E, Johnson L, Lawrence D, on behalf of the TACT Trial Management Group. Adjuvant taxanes for early breast cancer – clinical uncertainty exists. British Breast Group, July 6–7 2001b, Glasgow.

Hall E, Johnson L, Ellis P, Barrett-Lee P, Bliss JM, on behalf of the TACT Trials Management Group. How complete follow up (FU) datasets within the TACT trial could bring forward the release of outcome data. NCRI Cancer Conference, 2005 (poster).

Hopwood P, Ellis P, Barrett-Lee P, et al. on behalf of the TACT Trial Management Group. Impact on quality of life (QL) during chemotherapy (CT) of FEC-T compared to FEC or E-CMF: results from the UK NCRI Taxotere as Adjuvant Chemotherapy Trial (TACT). JCO 2005; 23: 16S 661 (poster) ASCO, 2005.

Hopwood P, Ellis P, Barrett-Lee P, et al. on behalf of the TACT Trial Management Group. Patients' views of distress and interference with daily activities due to side effects from chemotherapy for early breast cancer: the TACT (Taxotere as Adjuvant ChemoTherapy) trial experience. EBCC 2006a (poster).

Hopwood P, Ellis P, Barrett-Lee P, et al., on behalf of the TACT Trial Management Group. A comparison of clinician and patient symptom reporting during chemotherapy for adjuvant breast cancer: the TACT (Taxotere as Adjuvant ChemoTherapy) trial experience. EBCC 2006b (poster).

Johnson L, Bliss J, Ellis P, Barrett-Lee P, Johnston S, Yarnold J, for the Trial Management Groups and Trial Steering Committees for START and TACT. UK patients are willing to donate biological material for substudies in clinical trials. Eur J Cancer 2003; 1 (5): 416 (poster).

Johnson L, Bliss J, Johnston S, Ellis P, Yarnold J, for the Trial Management Groups and Trial Steering Committees for START and TACT. Patients are willing to donate biological material for substudies in clinical trials. Clin Oncol 2003; 15 (6): p4.1 (poster).

Johnson L, Bliss J, Johnston S, Yarnold J, for the Trial Management Groups and Trial Steering Committees for START and TACT. Biological substudies in clinical trials – UK patients are willing to donate biological material. Eur J Cancer 2003; Suppl 1 (4): O83 (oral presentation).

Johnson L, Bliss JM, Ellis P, Barrett-Lee P, Johnston S, on behalf of the TACT Trial Management Group. Blood samples for biological research – acceptance rate within the TACT trial. NCRI Cancer Conference, 2005 (poster).

Johnson L, Barrett-Lee P, Bliss J, on behalf of the TACT Trial Management Group. How do patients want to learn of results of clinical trials? – results of a survey of 1431 breast cancer patients taking part in the TACT trial. EBCC 2006 (poster).

Johnston SRD, Johnson L, Dowsett M, et al. on behalf of the TACT Trial Management Group – HER-2 status in primary breast cancer patients treated in the UK TACT trial – relationship with tumour size, grade, nodal involvement and ER status. Breast Cancer Research and Treatment 26th San Antonio Breast Cancer Symposium 2003; 82 (Suppl 1) (poster).

Topics

None available

Keywords

None available

***************************************************

Title

SoFEA: Study of Faslodex with or without concomitant Arimidex versus Exemestane following progression on non-steroidal Aromatase inhibitors.

ISRCTN: 44195747

Coordinator(s)

Dr S. Johnston, Royal Marsden Hospital, Fulham Road, LONDON SW3 6JJ, UNITED KINGDOM. Tel: +44 20 7808 2748

G. Kerson, C. Coombes, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 20 8722 4062/4039 Fax: +44 20 8770 7876 Email:

S. Russell, ISD Cancer Clinical Trials Team, 1st Floor Gyle Square, Area 159c, South Gyle, Edinburgh, SCOTLAND EH12 9EB, UNITED KINGDOM. Tel: +44 131 275 6746 Email:

Summary

  • Open to recruitment

Primary Objectives

  • To compare the progression-free survival of patients treated with Faslodex plus concomitant Arimidex versus Faslodex alone.
  • To compare the progression-free survival of patients treated with Faslodex alone versus those treated with the current standard, Exemestane.

Exploratory

  • To establish in accessible tumour biopsies from as many patients as possible relapsing on NSAIs, and in circulating tumour cells before and during treatment: tumour ER expression and activation status (i.e. phosphorylation status); tumour EGFR/HER2 expression and activation of the MAPK/ERK/IGFR/AKT signalling pathways.

Scheme

Update

  • Study opened to recruitment in March 2004. To end of January 2006, 110 patients randomized. Target accrual is 750 patients. Currently there are 85 open sites, 39 of which have randomized at least one patient.

Related publications

None available

Topics

  • Locally advanced breast cancer
  • Metastatic breast cancer
  • Postmenopausal patients
  • Hormone receptor positive breast cancer
  • Hormonal therapy
  • Aromatase inhibitors
  • Blood markers
  • Multiple drug resistance
  • Predictive markers

Keywords

None available

***************************************************

Title

TACT2: Trial of accelerated adjuvant chemotherapy with Capecitabine in early breast cancer.

ISRCTN68068041

Coordinator(s)

Dr D. Cameron, NCRN Coordinating Centre, Arthington House, Cookridge Hospital, Hospital Lane, Leeds LS16 6QB, UNITED KINGDOM. Tel: 44 (0) 113 392 4093 Fax: 44 (0) 113 392 4092 Email:

Dr P. Barrett-Lee, Velindre NHS Trust, Whitchurch, CARDIFF CF14 2TL, UNITED KINGDOM. Tel: +44 029 2031 6914 Fax: +44 029 2031 6267 Email:

Dr P. Canney, Beatson Oncology Centre, Western Infirmary, Dumbarton Road, GLASGOW G11 6NT, UNITED KINGDOM. Tel: +44 141 211 1743 Fax: +44 141 211 1866 Email:

M. Ross, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, Cotswold Road, Sutton, SURREY SM2 5PT, UNITED KINGDOM. Tel: +44 20 8722 4171 Fax: +44 20 8770 7876 Email:

Summary

  • Opened in December 2005
  • Target accrual: 4400

Objective

  • To assess whether accelerating the administration of adjuvant epirubicin, when given before CMF or Capecitabine, will improve its efficacy, and to evaluate whether the use of oral Capecitabine instead of CMF (after epirubicin) will be at least as effective as CMF and less toxic.

Substudies

  • Quality of life
  • Biological
  • Health economics

Scheme

Update

  • 55 patients recruited to end of February 2006.

Related publications

None available

Topics

None available

Keywords

Adjuvant chemotherapy

***************************************************

Title

FAST trial: Prospective randomized clinical trial testing 5.7 Gy and 6.0 Gy fractions of whole breast radiotherapy in terms of late normal tissue responses and tumour control.

Coordinator(s)

Professor J. Yarnold, Royal Marsden Hospital NHS Trust, Downs Road, Sutton, SURREY SM2 5PT, UNITED KINGDOM. Tel: +44 20 8661 3891 Fax: +44 20 8661 3107 Email:

M. Sydenham, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, Cotswold Road, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 20 8722 4104 Fax: +44 20 8770 7876 Email:

Summary

  • The trial opened in October 2004
  • Target accrual: 900 patients (300 per trial arm)

Objective

  • To test 5 fractions of 5.7 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.

Scheme

Update

  • 413 patients have been recruited into the trial by 01 March 2006 from a total of 21 centres.

Related publications

None available

Topics

  • Radiotherapy
  • Breast conservative treatment

Keywords

Hypofractionation, radiotherapy, breast cancer

***************************************************

Title

IMPORT low trial.

Coordinator(s)

J. Yarnold, Royal Marsden Hospital NHS Trust, Downs Road, Sutton, SURREY SM2 5PT, UNITED KINGDOM. Tel: +44 20 8661 3891 Fax: +44 20 8661 3107 Email:

J. Titley, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, 15 Cotswold Road, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 20 8722 4104 Fax: +44 20 8770 7876 Email:

Summary

  • Target accrual: 1935 patients

Objective

  • To test partial breast radiotherapy delivered using intensity modulated techniques following complete local tumour excision of low risk early breast cancer.

Scheme

Update

  • Recruitment opened in July 2006.

Related publications

None available

Topics

  • Radiotherapy
  • Loco-regional relapse
  • Breast conservative treatment

Keywords

Partial breast radiotherapy, intensity modulated radiotherapy, low risk, breast cancer

***************************************************

Title

IMPORT high trial.

Coordinator(s)

J. Yarnold, Royal Marsden Hospital NHS Trust, Downs Road, Sutton, SURREY SM2 5PT, UNITED KINGDOM. Tel: +44 20 8661 3891 Fax: +44 20 8661 3107 Email:

Jenny Titley, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, 15 Cotswold Road, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Tel: +44 20 8722 4104 Fax: +44 20 8770 7876 Email:

Summary

  • Target accrual: 840 patients

Objective

  • To test dose escalated intensity modulated radiotherapy after conservation surgery for early breast cancer in women with higher than average local recurrence risk.

Scheme

Update

  • Recruitment opened in July 2006.

Related publications

None available

Topics

  • Radiotherapy
  • Loco-regional relapse
  • Breast conservative treatment

Keywords

Dose escalation, intensity modulated radiotherapy, high risk, breast cancer

***************************************************

Title

Adjuvant chemotherapy in older women (ACTION).

Coordinator(s)

Professor R. Leonard, Department of Cancer Services and Clinical Haematology, Charing Cross Hospital, 3rd Floor, North Wing, Rooms B-C, Fulham Palace Road, LONDON W6 8RF, UNITED KINGDOM. Tel: +44 20 8846 7455 Fax: +44 20 8846 7454

Lee Conneely, Clinical Trials and Statistics Unit (ICR-CTSU), Section of Clinical Trials, The Institute of Cancer Research, Sir Richard Doll Building, 15 Cotswold Road, Sutton, SURREY SM2 5NG, UNITED KINGDOM. Email:

Summary

  • Due to open in Summer 2006
  • Target accrual: 1000

Objectives

  • To test the benefit of adjuvant chemotherapy (either AC or EC) in terms of disease-free survival in older women with high risk, ER negative/ER weakly positive breast cancer.
  • To evaluate accelerated therapy with GCSF in terms of toxicity in this patient group.
  • To evaluate the acceptability and tolerability of both chemotherapy regimens in this group of patients.

Substudies

  • Quality of life
  • Biological

Scheme

Update

  • Recruitment opened in Summer 2006.

Related publications

None available

Topics

None available

Keywords

Adjuvant, older women