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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00629616
First received: March 5, 2008
Last updated: August 5, 2014
Last verified: August 2014

March 5, 2008
August 5, 2014
August 2007
September 2016   (final data collection date for primary outcome measure)
Clinical tumor response as assessed by RECIST criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical tumor response at 6 months as assessed by RECIST criteria [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00629616 on ClinicalTrials.gov Archive Site
  • Breast surgery conservation rate [ Time Frame: Post surgery ] [ Designated as safety issue: No ]
  • Histological tumor response as assessed by the Sataloff scale [ Time Frame: Post surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Biological prognosis and predictive response factors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Relapse-free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Event-free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: During neoadjuvant treatment ] [ Designated as safety issue: Yes ]
  • Breast surgery conservation rate [ Designated as safety issue: No ]
  • Histological tumor response as assessed by the Sataloff scale [ Designated as safety issue: No ]
  • Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI at baseline, after the first month of treatment, and then before surgery [ Designated as safety issue: No ]
  • Biological prognosis and predictive response factors [ Designated as safety issue: No ]
  • Relapse-free survival rate at 3 years [ Designated as safety issue: No ]
  • Event-free survival rate at 3 years [ Designated as safety issue: No ]
  • Overall survival rate at 3 years [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer
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.

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.

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: anastrozole
    1 mg/day for either 4 months or 6 months depending on the clinical evaluation
  • 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
  • Experimental: Arm A
    Anastrozole
    Intervention: Drug: anastrozole
  • Experimental: Arm B
    Fulvestrant
    Intervention: Drug: fulvestrant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
116
September 2016
September 2016   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00629616
CARMINA02, CARMINA-02/0609, 2006-006409-10, NIMFEA
Yes
UNICANCER
UNICANCER
Not Provided
Principal Investigator: Florence Lerebours, MD Centre Rene Huguenin
UNICANCER
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP