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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Kansas
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00921115
First received: June 8, 2009
Last updated: December 19, 2013
Last verified: December 2013
  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.


Condition Intervention Phase
Invasive Breast Cancer
Drug: Fulvestrant
Drug: Anastrazole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Fulvestrant and Anastrozole as Neo-adjuvant Endocrine Therapy in Postmenopausal Women With Hormone Receptor Positive Invasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • To assess the pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant). [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess and correlate Response Rate, changes in Ki67 and recurrence score after neo-adjuvant combination endocrine therapy; determine the safety of this regimen. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: May 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Patients 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 clinically and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days during outpatient clinic visits. All treatment will continue for 4 months after which time patients will undergo breast surgery. 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.

Drug: Fulvestrant
Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.
Other Name: Faslodex
Drug: Anastrazole
Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
Other Name: Arimidex

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921115

Contacts
Contact: Stella Baccaray, RN 913-588-2937 sbaccaray@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Qamar Khan, MD    913-588-3659    qkhan@kumc.edu   
Principal Investigator: Qamar Khan, MD         
Sub-Investigator: Brian Petroff, PhD         
Sub-Investigator: Priyanka Sharma, MD         
Sub-Investigator: Carol Fabian, MD         
Sponsors and Collaborators
University of Kansas
AstraZeneca
Investigators
Principal Investigator: Qamar Khan, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00921115     History of Changes
Other Study ID Numbers: 11595, IRUSANAS0092
Study First Received: June 8, 2009
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kansas:
hormone receptor positive
invasive breast cancer
endocrine therapy
Anastrazole
Fulvestrant
breast tumors
postmenopausal

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Estrogens
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014