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Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

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ClinicalTrials.gov Identifier: NCT00543127
Recruitment Status : Terminated (Unjustified decision of company that funded the trial.)
First Posted : October 12, 2007
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:

Postmenopausal women with hormone receptor positive and negative Her2 tumours.

Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Fulvestrant Drug: Anastrozole Phase 3

Detailed Description:
It is expected that disease-free survival for patients receiving Anastrozole alone for 5 years will be up to 90%. An increase of 3% in disease-free survival (DFS) is expected in the arm of Fulvestrant plus Anastrozole, i.e a DFS of up to 93%. They will be required 1358 patients per treatment group (i.e, 2716 patients in total) to give 80% power, alfa bilateral 0.05, and OR 0.6888. Assuming 5% screening failures 2852 patients are required to enter the study. In Jun-2010 the recruitment was stopped due to lack of support of the financier based on the result of Faslodex® and Arimidex® in Combination Trial (FACT-trial), comparing Fulvestrant + Anastrozole vs Anastrozole alone in 1st relapse showed no difference in time to progression at more than 40 months follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial Comparing Efficacy and Tolerance of Fulvestrant for 3 Years (y) Combined With Anastrozole 5 y Versus Anastrozole 5 y as Adjuvant Hormonotherapy in Postmenopausal With Early Breast Cancer and Positive Hormone Receptors
Actual Study Start Date : November 2007
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Fulvestrant + Anastrozole
Fulvestrant loading dose regimen will consist of two 5 ml intramuscular injections on day 0 (500 mg), 250 mg single injection on days 14 and 28, and 250 mg single injection every 28 days thereafter for 3 years plus Anastrozole 1 mg PO once daily for 5 years
Drug: Fulvestrant
500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.
Other Name: Faslodex

Drug: Anastrozole
1 mg oral Anastrozole per day during 5 years.
Other Name: Arimidex

Active Comparator: Anastrozole
Anastrozole 1 mg will be administered orally as one tablet daily for 5 years.
Drug: Anastrozole
1 mg oral Anastrozole per day during 5 years.
Other Name: Arimidex




Primary Outcome Measures :
  1. Disease Free Survival (DFS) Events [ Time Frame: Up to 5 years ]

    Disease-free survival (DFS) has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

    DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.



Secondary Outcome Measures :
  1. Breast Cancer Specific Survival (BCsS) Events [ Time Frame: Up to 5 years ]

    BCsS events has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to BCsS in patients treated with anastrozole for 5 years.

    BCsS event is defined as the death from breast cancer.


  2. Overall Survival (OS) Event [ Time Frame: Up to 5 years ]

    OS event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

    OS event is defined as the death from any cause.


  3. Time to Recurrence (TR) Event [ Time Frame: Up to 5 years ]

    TR event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

    TR event is defined as the evidence of breast cancer recurrence (local and/or distant recurrence of breast cancer, does not include second primary malignancies or deaths from any cause).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histological documentation of breast cancer.
  2. Stage I, II, IIIA and IIIC* invasive breast cancer. One of these two characteristics must be fulfilled:

    • N+
    • T > 1cm *Eligible patients T1-T3 and pN3a (patients with metastasis in infraclavicular nodes would not be eligible)
  3. Local treatment with curative intention:

    • mastectomy or tumour excision with free margins + radiotherapy
    • axillary lymphadenectomy or sentinel node biopsy
  4. Positive hormone receptors (Estrogen Receptor [ER]+ and/or Progesterone Receptor [PR]+) in primary tumour tissue as measured by a central laboratory
  5. Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, defined as immunohistochemistry (IHC) 0 or 1+ or negative fluorescence in situ hybridization (FISH) (in the event of IHC 2+ or 3+)
  6. Postmenopausal women, defined as women meeting any of the following criteria:

    • Age ≥ 60 years
    • Age ≥ 45 years with amenorrhea ≥ 12 months in the moment of breast cancer diagnosis and an intact uterus
    • Prior bilateral ovariectomy
    • In case previous hysterectomy, follicle stimulating hormone (FSH) and estradiol levels within the postmenopausal range (using local laboratory ranges)* * In patients previously treated with a luteinizing hormone releasing hormone (LH-RH) analogue, the last extended release formulation should have been administered more than 6 months before randomisation, and menses must not have reappeared.
  7. A World Health Organization (WHO) performance status of 0, 1, or 2.
  8. Age > 18 years

Exclusion criteria:

  1. Presence of metastatic disease or bilateral invasive cancer
  2. ER and Progesterone Receptor (PR) negative breast cancer
  3. HER2-positive breast cancer, defined as FISH+
  4. Treatment with a non-approved or experimental drug within 4 months of randomisation
  5. Current malignancy or previous malignancy in the past 5 years (other that breast cancer or basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
  6. Pregnant or nursing patients
  7. Any of the following laboratory values within 3 months of randomisation:

    • Platelets < 100 x 109/L
    • Total bilirubin > 1.5 x Upper limit of reference range (ULRR)**

      ** Patients with documented Gilbert syndrome may be included in this trial

    • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2.5 x ULRR
    • A history of:
    • hemorrhagic diathesis (i.e. Disseminated Intravascular Coagulation [DIC], coagulation factor deficiency) or
    • long-term anticoagulant treatment (except for anti-platelet aggregants and low-dose warfarin; see section 3.7)
  8. A history of hypersensitivity to the active ingredient or inactive excipients of fulvestrant, aromatase inhibitors, or castor oil
  9. Any concomitant severe disease advising against patient participation in the trial o that may jeopardize compliance with the trial protocol, such as uncontrolled heart disease, uncontrolled diabetes mellitus, or uncontrolled severe infections
  10. Hormone replacement therapy

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 ClinicalTrials.gov identifier (NCT number): NCT00543127


Locations
Show Show 53 study locations
Sponsors and Collaborators
Spanish Breast Cancer Research Group
AstraZeneca
Investigators
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Study Director: Study Director Hospital General Universitario Gregorio Marañón
Study Director: Study Director Centro Oncológico de Galicia
Study Director: Study Director Hospitales Universitarios Virgen del Rocío
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00543127    
Other Study ID Numbers: GEICAM/2006-10
First Posted: October 12, 2007    Key Record Dates
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
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