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Status:

COMPLETED

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

Lead Sponsor:

UNICANCER

Conditions:

Breast Cancer

Eligibility:

FEMALE

Phase:

PHASE2

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 blocki...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2018

    Estimated Enrollment :

    116 Patients enrolled

    Trial Details

    Trial ID

    NCT00629616

    Start Date

    October 1 2007

    End Date

    April 1 2018

    Last Update

    June 9 2021

    Active Locations (6)

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    Page 1 of 2 (6 locations)

    1

    Centre Jean Perrin

    Clermont-Ferrand, France, 63011

    2

    Hopital Dupuytren

    Limoges, France, 87042

    3

    Institut Curie Hopital

    Paris, France, 75248

    4

    Centre Eugene Marquis

    Rennes, France, 35042