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

NCT00253422 | Completed Phase 3 Results DMC

• 5 other identifiers: CDR0000448616ICR-CTSU-SOFEAISRCTN44195747MREC-036772004-000093-30
• Study Type: interventional
• Target: 698
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

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.

  Assessed up to 190 months

Secondary Outcomes (7)

• Objective Response Rate

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

• Duration of Response

  Assessed up to 190 months

• Clinical Benefit Rate

  Assessed up to 190 months

• Duration of Clinical Benefit

  Assessed up to 190 months

• Time to Treatment Failure

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

Study Arms (3)

Faslodex + placebo

ACTIVE COMPARATOR

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

Faslodex + Arimidex

ACTIVE COMPARATOR

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

Exemestane

ACTIVE COMPARATOR

exemestane orally once a day

Drug: Exemestane

Interventions

Anastrozole DRUG

This may be Anastrazole OR a placebo

Also known as: Arimidex (or placebo)

Faslodex + Arimidex; Faslodex + placebo

Exemestane DRUG

Exemestane

Fulvestrant DRUG

Also known as: Faslodex

Faslodex + Arimidex; Faslodex + placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (2)

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Institute Of Cancer Research

Sutton, England, SM2 5NG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 23902874 RESULT

• 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.

  PMID: 27269946 DERIVED

Related Links

• Clinical trial summary from ICR website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; exemestane; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Professor Judith Bliss (Director of ICR-CTSU)
• Organization: Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU)

aude.espinasse@icr.ac.uk

+44 0208 722

Study Officials

• Stephen RD Johnston, MD,PhD,FRCP

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Arimidex vs Arimidex-placebo component is double-blinded. Faslodex is not blinded Exemestane is not blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Study Start: March 26, 2004
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available to researchers following the formal review and approval of a data access request in accordance with the ICR-CTSU data and sample access policy.
• Access Criteria: Completion and approval of a data access request form as stated above

Locations

GB (2)