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CompletedNCT00253422SoFEAUpdated Jun 4, 2025Results posted

Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors

A Phase 3 interventional study of Anastrozole and Exemestane in Breast Cancer, sponsored by Institute of Cancer Research, United Kingdom. Completed at 2 sites in United Kingdom. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Institute of Cancer Research, United Kingdom · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Mar 2004, registered Nov 2005).
Phase
Phase 3
Study type
Interventional
Enrollment
698
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
Female
01

Study summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.

PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare progression-free survival of postmenopausal women with estrogen receptor- and/or progesterone receptor-positive, locally advanced or metastatic breast cancer that relapsed or progressed during prior treatment with nonsteroidal aromatase inhibitors treated with fulvestrant with vs without anastrozole vs exemestane alone.

Secondary

  • Compare the objective complete response (CR) and partial response (PR) rate and duration of response in patients treated with these regimens.
  • Compare the clinical benefit (i.e., 6-month CR, PR, and stable disease) rate and duration of clinical benefit in patients treated with these regimens.
  • Compare time to treatment failure in patients treated with these regimens.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the tolerability of these regimens in these patients.

OUTLINE: This is a randomized, partially double-blind and placebo-controlled, multicenter study. Patients are stratified according to the setting in which prior nonsteroidal aromatase-inhibitor therapy was given (adjuvant therapy vs first-line therapy) and participating center. Patients are randomized to 1 of 3 treatment arms.

  • Arm I (fulvestrant and anastrozole): Patients receive fulvestrant intramuscularly (IM) on days 1, 15, and 29 and then once monthly. Patients receive oral anastrozole once daily.
  • Arm II (fulvestrant and placebo): Patients receive fulvestrant as in arm I and oral placebo once daily.
  • Arm III (exemestane alone): Patients receive oral exemestane once daily. In all arms, treatment repeats every month in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 750 patients (250 per treatment arm) will be accrued for this study.

02

Conditions studied

  • Breast Cancer

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Keywords

  • recurrent breast cancer
  • stage IV breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 698 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Institute of Cancer Research, United Kingdom is the lead sponsor of 111 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Locally advanced or metastatic disease

  • Metastatic disease must be measurable or evaluable

    • Patients with bone only metastases are eligible provided there is an evaluable site of bone metastasis that can be followed by x-ray, MRI, or CT scan

  • Relapsed or progressed during prior treatment with single-agent nonsteroidal aromatase inhibitor (NSAI)*, meeting either of the following criteria:

    • NSAI given as adjuvant therapy that lasted ≥ 12 months

    • Achieved an objective complete response, partial response, or stable disease that lasted ≥ 6 months after prior first-line therapy with NSAI for locally advanced or metastatic disease

      • Chemotherapy as part of the first-line therapy given before initiation of NSAI allowed NOTE: *Patients are required to continue to take NSAI until beginning of study treatment.
  • No rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa or diffuse hepatic involvement)

  • Hormone receptor status:

    • Estrogen receptor (ER) and/or progesterone receptor positive tumor
    • No ER-unknown disease

PATIENT CHARACTERISTICS:

Sex

  • Female

Menopausal status

  • Postmenopausal, as defined by 1 of the following criteria:

    • Age 60 and over
    • Age 45 to 59 AND ≥ 12 months since last menstrual period with no prior hysterectomy
    • Any age with prior bilateral oophorectomy

Performance status

  • WHO 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Neutrophil count ≥ 1,500/mm\^3

  • Platelet count ≥ 100,000/mm\^3

    • No thrombocytopenia
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN (unless due to bone metastases)
  • No liver disease

Renal

  • Creatinine \< 1.97 mg/dL

Other

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • See Disease Characteristics
  • Prior neoadjuvant or adjuvant chemotherapy allowed

Endocrine therapy

  • See Disease Characteristics
  • Prior tamoxifen as neoadjuvant or adjuvant therapy allowed
  • No systemic corticosteroids that lasted > 15 days within the past 4 weeks

Other

  • More than 4 weeks since prior investigational drugs

  • Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy has been established for ≥ 6 months

    • Concurrent initiation of bisphosphonate allowed provided patient has soft tissue or visceral metastases as the measurable or evaluable target lesion
  • No concurrent anticoagulant therapy
  • No concurrent unlicensed noncancer investigational agents
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
698 participants (actual)

Study arms

  • Active comparator
    Faslodex + placebo

    Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day

    Drug: Anastrozole · Drug: Fulvestrant

  • Active comparator
    Faslodex + Arimidex

    Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day

    Drug: Anastrozole · Drug: Fulvestrant

  • Active comparator
    Exemestane

    exemestane orally once a day

    Drug: Exemestane

Interventions

  • DrugAnastrozole

    This may be Anastrazole OR a placebo

    Also known as: Arimidex (or placebo)

  • DrugExemestane
  • DrugFulvestrant

    Also known as: Faslodex

06

What researchers measure

Primary outcomes

  1. Progression-free Survival

    defined as time from randomisation to progression of existing disease, new sites of disease, second primary cancer if change in systemic treatment was necessary, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Time frame: Assessed up to 190 months

Secondary outcomes

  1. Objective Response Rate

    The proportion of patients identified as having a complete response (CR) or partial response (PR) at any time whilst on study treatment. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Objective Response (OR) = CR + PR

    Time frame: From start of treatment, every 3 months to treatment discontinuation and/or up to 190 months

  2. Duration of Response

    time from first assessment of response to progression or death. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Time frame: Assessed up to 190 months

  3. Clinical Benefit Rate

    Complete or partial response or stable disease for at least six months prior to progression. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Stable disease is neither responding or progressing. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Time frame: Assessed up to 190 months

  4. Duration of Clinical Benefit

    Time from first assessment of clinical benefit to progression or death. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Stable disease is neither responding or progressing. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical benefit = (CR+PR)+(SD\>=6months).

    Time frame: Assessed up to 190 months

  5. Time to Treatment Failure

    Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease

    Time frame: To discontinuation of protocol treatment for any reason, or progression of disease assessed up to 190 months

  6. Overall Survival

    Time from randomisation until death from any cause.

    Time frame: To death assessed up to 190 months.

  7. Tolerability of Treatment

    To evaluate the overall safety and tolerability. The number of patients experiencing at least one adverse event. Refer to adverse event section for more details.

    Time frame: From start of treatment to discontinuation of treatment/progression assessed up to 190 months

07

Results

Posted Jun 4, 2025

Participant flow

Patients were recruited between 26 March 2004 and 6 August 2010 from 82 hospitals in the UK.

Participant flow — Overall Study
MilestoneFaslodex + PlaceboFaslodex + ArimidexExemestane
Started226233239
Completed226233238
Not completed001

Outcome measures

PrimaryProgression-free Survival

defined as time from randomisation to progression of existing disease, new sites of disease, second primary cancer if change in systemic treatment was necessary, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:
Assessed up to 190 months
Reported as:
Median · Months
Progression-free Survival
MonthsFaslodex + PlaceboFaslodex + ArimidexExemestane
Progression-free Survival4.8 (3.5 to 5.6)4.1 (3.2 to 5.3)3.5 (3.0 to 4.9)
Statistical analysis
  • Faslodex + Placebo vs Faslodex + Arimidex · Log Rank · p = 0.76 · Hazard ratio (hr): 1.03 · 95% CI 0.86 to 1.24
  • Faslodex + Placebo vs Exemestane · Log Rank · p = 1.00 · Hazard ratio (hr): 1.00 · 95% CI 0.83 to 1.20
SecondaryObjective Response Rate

The proportion of patients identified as having a complete response (CR) or partial response (PR) at any time whilst on study treatment. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Objective Response (OR) = CR + PR

Time frame:
From start of treatment, every 3 months to treatment discontinuation and/or up to 190 months
Reported as:
Count of participants · Participants
Objective Response Rate
ParticipantsFaslodex + PlaceboFaslodex + ArimidexExemestane
Objective Response Rate161710
Statistical analysis
  • Faslodex + Placebo vs Faslodex + Arimidex · Chi-squared · p = 0.99
  • Faslodex + Placebo vs Exemestane · Chi-squared · p = 0.12
SecondaryDuration of Response

time from first assessment of response to progression or death. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:
Assessed up to 190 months
Reported as:
Median · Months
Duration of Response
MonthsFaslodex + PlaceboFaslodex + ArimidexExemestane
Duration of Response10.2 (2.6 to 18.4)8.7 (3.0 to 12.2)12.8 (6.2 to 33.4)
SecondaryClinical Benefit Rate

Complete or partial response or stable disease for at least six months prior to progression. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Stable disease is neither responding or progressing. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame:
Assessed up to 190 months
Reported as:
Count of participants · Participants
Clinical Benefit Rate
ParticipantsFaslodex + PlaceboFaslodex + ArimidexExemestane
Clinical Benefit Rate556657
Statistical analysis
  • Faslodex + Placebo vs Faslodex + Arimidex · Chi-squared · p = 0.33
  • Faslodex + Placebo vs Exemestane · Chi-squared · p = 0.94
SecondaryDuration of Clinical Benefit

Time from first assessment of clinical benefit to progression or death. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Stable disease is neither responding or progressing. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical benefit = (CR+PR)+(SD\>=6months).

Time frame:
Assessed up to 190 months
Reported as:
Median · months
Duration of Clinical Benefit
monthsFaslodex + PlaceboFaslodex + ArimidexExemestane
Duration of Clinical Benefit11.2 (8.2 to 16.9)11.5 (8.0 to 16.3)12.2 (8.9 to 23.8)
SecondaryTime to Treatment Failure

Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease

Time frame:
To discontinuation of protocol treatment for any reason, or progression of disease assessed up to 190 months
Reported as:
Median · Months
Time to Treatment Failure
MonthsFaslodex + PlaceboFaslodex + ArimidexExemestane
Time to Treatment Failure3.8 (3.1 to 5.4)3.9 (3.0 to 4.7)3.4 (3.1 to 4.5)
Statistical analysis
  • Faslodex + Placebo vs Faslodex + Arimidex · Log Rank · p = 0.95 · Hazard ratio (hr): 1.01 · 95% CI 0.84 to 1.21HR less than 1 favour Faslodex + Arimidex
  • Faslodex + Placebo vs Exemestane · Log Rank · p = 0.66 · Hazard ratio (hr): 1.04 · 95% CI 0.87 to 1.25HR less than 1 favours Faslodex + placebo
SecondaryOverall Survival

Time from randomisation until death from any cause.

Time frame:
To death assessed up to 190 months.
Reported as:
Median · Months
Overall Survival
MonthsFaslodex + PlaceboFaslodex + ArimidexExemestane
Overall Survival20.1 (17.8 to 23.3)20.2 (17.0 to 22.6)22.5 (20.1 to 24.6)
Statistical analysis
  • Faslodex + Placebo vs Faslodex + Arimidex · Log Rank · p = 0.91 · Hazard ratio (hr): 0.99 · 95% CI 0.82 to 1.19HR less than 1 favours Faslodex + Arimidex
  • Faslodex + Placebo vs Exemestane · Log Rank · p = 0.31 · Hazard ratio (hr): 1.10 · 95% CI 0.91 to 1.32HR less than 1 favours Faslodex + Placebo
SecondaryTolerability of Treatment

To evaluate the overall safety and tolerability. The number of patients experiencing at least one adverse event. Refer to adverse event section for more details.

Time frame:
From start of treatment to discontinuation of treatment/progression assessed up to 190 months
Reported as:
Count of participants · Participants
Tolerability of Treatment
ParticipantsFaslodex + PlaceboFaslodex + ArimidexExemestane
Tolerability of Treatment221227230

Adverse events

Collected over Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Faslodex + Placebo221/226 (97.8%)31/225 (13.8%)221/225 (98.2%)
Faslodex + Arimidex225/233 (96.6%)39/231 (16.9%)227/231 (98.3%)
Exemestane227/239 (95%)37/237 (15.6%)230/237 (97%)
Most frequent serious events
Showing 10 of 106
Most frequent serious events
EventFaslodex + PlaceboFaslodex + ArimidexExemestane
DyspnoeaRespiratory, thoracic and mediastinal disorders7/2252/2313/237
nauseaGastrointestinal disorders2/2254/2312/237
Pulmonary embolismRespiratory, thoracic and mediastinal disorders1/2254/2311/237
VomitingGastrointestinal disorders3/2253/2312/237
FatigueGeneral disorders3/2250/2311/237
PneumoniaInfections and infestations3/2250/2313/237
Confusional statePsychiatric disorders3/2251/2310/237
PalpitationsCardiac disorders0/2253/2310/237
HypercalcaemiaMetabolism and nutrition disorders0/2253/2310/237
Chest painGeneral disorders1/2250/2313/237
Most frequent other events
Showing 10 of 22
Most frequent other events
EventFaslodex + PlaceboFaslodex + ArimidexExemestane
LethargyGeneral disorders145/225149/231133/237
ArthralgiaMusculoskeletal and connective tissue disorders98/22597/231110/237
VomitingGastrointestinal disorders101/22581/23191/237
Hot FlushReproductive system and breast disorders81/22586/23179/237
InsomniaPsychiatric disorders64/22576/23170/237
decreased appetiteMetabolism and nutrition disorders67/22572/23168/237
DyspepsiaGastrointestinal disorders59/22551/23170/237
HeadacheNervous system disorders65/22551/23151/237
ConstipationGastrointestinal disorders57/22564/23157/237
Mood alteredPsychiatric disorders59/22555/23159/237

Baseline characteristics

ITT

Age, Continuous
Age, Continuous(years)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
Median63.2 (57.0 to 73.6)64.1 (57.6 to 72.3)66.1 (59.2 to 75.3)64.7 (58.0 to 73.5)
Age, Customized
Age, Customized(Participants)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
<50 years1721745
50 to 64 years102104100306
65 to 74 years616570196
>=75 years464362151
Sex: Female, Male
Sex: Female, Male(Participants)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
Female226233239698
Male0000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(participants)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
United Kingdom226233239698
Hormone Receptor Status of primary disease
Hormone Receptor Status of primary disease(Participants)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
ER+ve PR+ve121111123355
ER+ve PR -ve31382291
ER+ve PR unknown718391245
ER-ve/unknown PR+ve0123
ER unknown PR unknown2013
ER-ve PR-ve1001
HER2 Status of primary disease
HER2 Status of primary disease(Participants)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
HER2 +ve14151544
HER2 -ve136117134387
HER2 unknown7610190267
Time from primary diagnosis to first relapse
Time from primary diagnosis to first relapse(years)Faslodex + PlaceboFaslodex + ArimidexExemestaneTotal
Median5.1 (2.3 to 9.6)5.0 (2.0 to 10.0)5.2 (1.9 to 10.3)5.1 (2.1 to 10.0)
08

Study locations

2 sites
  • Royal Marsden - London
    London, England SW3 6JJ, United Kingdom
  • Institute Of Cancer Research
    Sutton, England SM2 5NG, United Kingdom
09

References and documents

Publications

  • Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29. PubMed 23902874 ↗
  • Fribbens C, O'Leary B, Kilburn L, Hrebien S, Garcia-Murillas I, Beaney M, Cristofanilli M, Andre F, Loi S, Loibl S, Jiang J, Bartlett CH, Koehler M, Dowsett M, Bliss JM, Johnston SR, Turner NC. Plasma ESR1 Mutations and the Treatment of Estrogen Receptor-Positive Advanced Breast Cancer. J Clin Oncol. 2016 Sep 1;34(25):2961-8. doi: 10.1200/JCO.2016.67.3061. Epub 2016 Jun 6. PubMed 27269946 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 19, 2008

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual participant data, together with a data dictionary defining each field in the set, will be made available to other researchers on request, subject to the approval of a formal data access request in accordance with the ICR-CTSU data and sample access policy. Trial documentation including the protocol are available on request by contacting Formal requests for data sharing are considered in line with ICR-CTSU procedures. Requests are via a standard proforma describing the nature of the proposed research and extent of data requirements. Contact sofea-icrctsu@icr.ac.uk or visit the link below for further information.

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00253422
Lead sponsor
Institute of Cancer Research, United Kingdom
Collaborators
Royal Marsden NHS Foundation Trust
Responsible party
Sponsor
First posted
Nov 15, 2005
Start date
Mar 26, 2004
Primary completion
Nov 28, 2022
Completion
Nov 28, 2022
Results posted
Jun 4, 2025
Last update
Jun 4, 2025

Study contacts

Stephen RD Johnston, MD,PhD,FRCP
study chair · Royal Marsden NHS Foundation Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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