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Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer (NIMFEA)

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: NCT00629616
Recruitment Status : Unknown
Verified August 2014 by UNICANCER.
Recruitment status was:  Active, not recruiting
First Posted : March 6, 2008
Last Update Posted : August 6, 2014
Information provided by (Responsible Party):

Brief Summary:

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: anastrozole Drug: fulvestrant Phase 2

Detailed Description:



  • To compare the clinical response rates (complete and partial responses) at 6 months in postmenopausal women with operable stage II or III breast cancer treated with neoadjuvant anastrozole vs fulvestrant.


  • To compare the breast surgery conservation rate in patients treated with these drugs.
  • To correlate imaging findings by mammography, ultrasonography, and MRI with histological and clinical response in these patients and with sensitivity profile to these drugs.
  • To compare histological response in patients treated with these drugs.
  • To define criteria appropriate for neoadjuvant hormonal therapy.
  • To correlate baseline molecular characteristics and modifications during treatment with response in these patients.
  • To compare the tolerability of these drugs in these patients.
  • To compare the serum proteomic profile of patients treated with these drugs.
  • To correlate 3-year event-free and overall survival rates with clinical and histological response in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral anastrozole once daily for 4-6 months in the absence of clinical progression.
  • Arm II: Patients receive fulvestrant intramuscularly on days 1, 15, and 29 in the first month and then every 28 days in each subsequent month. Treatment continues for 4-6 months in the absence of clinical progression.

Patients in both arms then undergo surgery and radiotherapy according to institutional guidelines. Patients then receive adjuvant hormonal therapy for at least 5 years.

After completion of study therapy, patients are followed periodically for up to 3 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.
Study Start Date : August 2007
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A
Drug: anastrozole
1 mg/day for either 4 months or 6 months depending on the clinical evaluation

Experimental: Arm B
Drug: fulvestrant
500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation

Primary Outcome Measures :
  1. Clinical tumor response as assessed by RECIST criteria [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Breast surgery conservation rate [ Time Frame: Post surgery ]
  2. Histological tumor response as assessed by the Sataloff scale [ Time Frame: Post surgery ]
  3. Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI [ Time Frame: at baseline, after the first month of treatment, and then before surgery ]
  4. Biological prognosis and predictive response factors [ Time Frame: 3 years ]
  5. Relapse-free survival rate [ Time Frame: 3 years ]
  6. Event-free survival rate [ Time Frame: 3 years ]
  7. Overall survival rate [ Time Frame: 3 years ]
  8. Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: During neoadjuvant treatment ]

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 confirmed infiltrating breast adenocarcinoma

    • Large, operable tumor
    • Stage T2 (≥ 3 cm) or T3-T4 (excluding inflammatory disease), N0-N3, M0 disease

      • No bilateral inflammatory breast tumors (T4d [PEV-2 or PEV-3])
    • Elston-Ellis grade I or II and mitotic index 1 or 2 (if < 65 years of age)
  • At least 1 embedded and 1 frozen biopsy sample available
  • No multifocal or multicentric tumors for which breast conservation cannot be envisaged
  • No ErbB2-overexpressing tumors (HER2 3+ by IHC OR HER2 2+ by IHC and FISH positive)
  • Hormone receptor status:

    • Estrogen receptor and/or progesterone receptor positive tumor (> 10%) as assessed by IHC


  • Female
  • Postmenopausal
  • ECOG performance status 0-2
  • ANC ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.25 times ULN
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No other cancer within the past 10 years, except basal cell skin cancer or previously treated carcinoma in situ of the cervix
  • No uncontrolled cardiac pathology, including any of the following:

    • Angina pectoris
    • Congestive cardiac insufficiency
    • Myocardial infarction within the past 3 months
  • No known history of hemorrhagic diathesis
  • No known allergy to the study drugs or their excipients
  • No congenital galactosemia, glucose malabsorption syndrome, or lactase deficiency
  • No chronic somatic or psychiatric illness with pejorative prognosis
  • No geographical, social, or psychiatric condition that would preclude study compliance and follow-up schedule
  • No individual deprived of liberty or placed under the authority of a tutor


  • No prior chemotherapy, hormonal therapy, or any targeted treatment for the breast tumor
  • At least 2 weeks since prior hormone replacement therapy for menopause
  • No concurrent long-term anticoagulation treatment
  • No concurrent participation on another therapeutic trial involving an experimental molecule

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): NCT00629616

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Centre Jean Perrin
Clermont-Ferrand, France, 63011
Hopital Dupuytren
Limoges Cedex, France, 87042
Institut Curie Hopital
Paris, France, 75248
Centre Eugene Marquis
Rennes, France, 35042
Centre Rene Huguenin
Saint-Cloud, France, 92210
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
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Principal Investigator: Florence Lerebours, MD Institut Curie
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: UNICANCER Identifier: NCT00629616    
Other Study ID Numbers: CARMINA02
CARMINA-02/0609 ( Other Identifier: UNICANCER )
2006-006409-10 ( EudraCT Number )
NIMFEA ( Other Identifier: UNICANCER )
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014
Keywords provided by UNICANCER:
stage II breast cancer
stage IIIA 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