Clinical Trials /

Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.

NCT00921115

Description:

This study is being done to test the safety and effectiveness of two drugs, Anastrozole and Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor positive invasive breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.
  • Official Title: Combined Fulvestrant and Anastrozole as Neo-adjuvant Endocrine Therapy in Postmenopausal Women With Hormone Receptor Positive Invasive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 11595
  • SECONDARY ID: IRUSANAS0092
  • NCT ID: NCT00921115

Conditions

  • Invasive Breast Cancer

Interventions

DrugSynonymsArms
FulvestrantFaslodexArimidex + Faslodex
AnastrazoleArimidexArimidex + Faslodex

Purpose

This study is being done to test the safety and effectiveness of two drugs, Anastrozole and Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor positive invasive breast cancer.

Detailed Description

      Hormonal therapies are generally preferred treatments of breast cancer because they have
      minimal side effects. Hormone receptor positive breast cancer generally does not respond very
      well to chemotherapy, which has many side effects. Hormonal therapy with a single drug such
      as Anastrozole is the main type of treatment used to reduce the risk of cancer recurrence.
      Whether a combination of Anastrazole nad Fulvestrant is effective and feasible is not known.
      This study is being done to answer this question.

      This is a phase II single arm study. Patients will have an Oncotype Dx performed and only if
      the recurrence score is low or intermediate, they would be eligible. Eligible patients will
      receive Anastrazole and Fulvestrant for 16 week.

      Subjects will receive Anastrazole 1 mg po q day and Fulvestrant 500 mg IM, day 1, day 14, day
      28 and thereafter once every 28 days on outpatient basis. On day 28, subjects will be
      evaluated for side effects and clinically and a needle core biopsy (optional) will be
      obtained. If there is increase in Ki 67 by 50%, subjects will be taken off the study.
      Response evaluation will occur every 28 days during outpatient clinic visits. All treatment
      will continue until 4 months when patients will undergo surgical intervention. After surgery,
      patients will be off study and will receive additional breast cancer therapy at the
      discretion of their treating physician. Patients who develop progressive disease on protocol
      will be removed from the study and will then be treated at the discretion of the treating
      physician. The protocol will be closed after the last accrued patient has had surgery.
    

Trial Arms

NameTypeDescriptionInterventions
Arimidex + FaslodexExperimentalPatients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks. On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.
  • Fulvestrant
  • Anastrazole

Eligibility Criteria

        Inclusion criteria

          -  Female patient > 18 years of age.

          -  Histologically proven invasive adenocarcinoma of the breast.

          -  Patients must be candidates for neoadjuvant treatment (Tumor size > 2cm and/or
             clinical N1 or N2).

          -  ER positive (> 10% of cells) and/or PgR positive (> 10% of the cells) and HER-2
             negative disease (IHC 0 or 1+ and/or FISH negative, IHC 2+ and FISH negative)

          -  Menopausal status

               -  Patients must be post-menopausal as defined by one of the following criteria:

                    -  Prior bilateral oophorectomy

                    -  12 months since LMP with no prior hysterectomy

                    -  Patients > 55 years with prior hysterectomy

                    -  Patients < 55 years of age and with a prior hysterectomy without
                       oophorectomy, estradiol and FSH levels must be consistent with the patient
                       being postmenopausal.

               -  Premenopausal or perimenopausal women who do not meet the postmenopausal criteria
                  above are also eligible, but are required to undergo ovarian suppression with an
                  LHRH agonist. Ovarian suppression can be initiated any time prior to or on day 1
                  of protocol therapy and must continue throughout protocol therapy.

          -  Performance status of 2 or better per SWOG criteria

          -  No prior chemotherapy or endocrine therapy for the current cancer diagnosis.

          -  If female of childbearing potential, pregnancy test is negative prior to initiation of
             ovarian suppression.

          -  Patients must be informed of the investigational nature of the study, and must sign an
             informed consent in accordance with the institutional rules.

          -  Oncotype Dx Recurrence Score </= 25.

        Exclusion criteria

          -  Patients with metastatic disease.

          -  The presence of any other medical or psychiatric disorder that, in the opinion of the
             treating physician, would contraindicate the use of drugs in this protocol or place
             the subject at undue risk for treatment complications.

          -  Premenopausal without ovarian suppression.

          -  Pregnancy or lactation.

          -  Patients with concomitant or previous malignancies within the last 5 years, with the
             exception of adequately treated basal or squamous cell carcinoma of the skin or
             carcinoma in situ of the cervix.

          -  Patients with emotional limitations are excluded from study

          -  Platelets less than 100 x 109 /L

          -  Total bilirubin greater than 1.5 x ULRR

          -  ALT or AST greater than 2.5 x ULRR

          -  History of bleeding diathesis (i.e., disseminated intravascular coagulation [DIC],
             clotting factor deficiency) or long-term anticoagulant therapy (other than
             antiplatelet therapy).

          -  History of hypersensitivity to active or inactive excipients of fulvestrant (i.e.
             castor oil or Mannitol).

          -  Oncotype Dx Recurrence Score of >25.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic Complete Response (PCR) Rate
Time Frame:4 months
Safety Issue:
Description:Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:University of Kansas Medical Center

Trial Keywords

  • hormone receptor positive
  • invasive breast cancer
  • endocrine therapy
  • Anastrazole
  • Fulvestrant
  • breast tumors
  • postmenopausal

Last Updated

April 12, 2017