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Fulvestrant With or Without Anastrozole or Exemestane Alone in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00253422
Recruitment Status : Unknown
Verified May 2011 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2005
Last Update Posted : May 17, 2011
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: anastrozole Drug: exemestane Drug: fulvestrant Phase 3

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Partially-Blind Phase III Randomized Trial of Fulvestrant (Faslodex™) With or Without Concomitant Anastrozole (Arimidex™) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
Study Start Date : March 2004
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Objective complete response (CR) and partial response (PR) rate
  2. Duration of response
  3. Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
  4. Duration of clinical benefit
  5. Time to treatment failure
  6. Overall survival
  7. Tolerability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 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


  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

    • No thrombocytopenia
  • Hemoglobin ≥ 10 g/dL


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


  • Creatinine < 1.97 mg/dL


  • 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



  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00253422

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United Kingdom
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom, SM2 5NG
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
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Study Chair: Stephen R. D. Johnston, MD, PhD, FRCP Royal Marsden NHS Foundation Trust
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00253422    
Other Study ID Numbers: CDR0000448616
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2011
Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action