Arimidex With or Without Faslodex In Postmenopausal Women With HR Positive Breast Cancer (PACT001)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Baylor Breast Care Center
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00570323
First received: December 6, 2007
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

Over the last 3 decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery, or lumpectomy plus radiation therapy, are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials have established the value of postoperative systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality, and better ways to predict and optimize outcome are needed.

Combination endocrine therapy: Using endocrine agents with different mechanisms of action together has the potential advantage of more effectively blocking ER signaling, thus improving the efficacy of such agents against breast cancer. In the past, attempts to combine endocrine agents for ER-positive breast cancer have had mixed results, depending on the setting and the patient population studied.

Endocrine agents without any agonist effect could potentially be used in combination with aromatase inhibitors, under the rationale that the combination would maximally blockade estrogen receptor signaling, thus potentially improving the antitumor effect. Fulvestrant (FASLODEX) is a pure estrogen antagonist with no known agonist effect; thus, it has the potential to provide additional benefit when combined with an aromatase inhibitor. This concept provides the rationale for using the combination of anastrazole and fulvestrant in this study.


Condition Intervention Phase
Breast Cancer
Drug: Arimidex with Faslodex
Drug: Arimidex without Faslodex
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant Arimidex With or Without Faslodex in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • The primary objective of this study is to determine if ER-targeted therapy, ARIMIDEX and FASLODEX, used in combination is superior to ARMIDEX alone in hormone receptor positive breast cancer. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Primary study objective 1. To determine the efficacy of primary breast cancer, as measured by decrease in proliferation (KI67), to the combination of ARIMIDEX, and FASLODEX at high dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary study objectives 1. To study molecular changes in response to treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 2. To correlate changes in Ki67 with clinical response [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • 3. To determine the pathologic response rate. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 4. To assess the tolerability and safety of the combination regimen. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arimidex with Faslodex in postmenopausal women
Drug: Arimidex with Faslodex
Arimidex with Faslodex
Other Names:
  • Arimidex
  • Faslodex
Active Comparator: 2
Arimidex without Faslodex in postmenopausal women.
Drug: Arimidex without Faslodex
Arimidex without Faslodex
Other Names:
  • ARIMIDEX
  • FASLODEX

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects must be female.
  • Postmenopausal status, defined as any one of the following criteria:

    • Documented history of bilateral oophorectomy.
    • Age 60 years or more.
    • Age 45 to 59 and satisfying one or more of the following criteria:

      • Amenorrhea for at least 12 months and intact uterus.
      • Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.
  • Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.
  • Estrogen receptor and/or progesterone receptor positive disease.
  • Patients must not have received any prior treatment for current or newly diagnosed breast cancer.
  • Patients must have not received previous treatment with any of the study medications or similar drugs.
  • No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.
  • WHO performance status of 0, 1, or 2.
  • Adequate organ function defined as follows:

    • Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.
    • Adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal.
    • Adequate bone marrow function, defined as a WBC greater than 3.0 ml, PLT greater than 75,000/ul, Hb greater than 9 gm/l.
  • Willing to undergo breast core biopsies as required by the study protocol. - Ability to understand and sign a written informed consent for participation in the trial.
  • Life expectancy of at least 1 year.

Exclusion Criteria:

  • Premenopausal status.
  • Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.
  • Patients with brain metastasis.
  • WHO performance status of 3 or 4.
  • Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  • Platelet count less than 75,000.
  • In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.
  • History of hypersensitivity to castor oil.
  • Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.
  • Patients with contralateral second primary breast cancers are eligible.
  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: NCT00570323

Contacts
Contact: Kristen Otte, BS 713-798-1999 kristen.otte@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kristen Otte, BS    713-798-1999    Kristen.Otte@bcm.edu   
Contact: Brenda Reusser, BA    713-798-1929    breusser@bcm.edu   
Sub-Investigator: Mothaffar Rimawi, MD         
Sub-Investigator: Garrett Lynch, MD         
Sub-Investigator: Kent Osborne, MD         
Sub-Investigator: Julie Nangia, MD         
Sub-Investigator: Polly Niravath, MD         
Sub-Investigator: Sao Jiralerspong, MD         
Doctors Hospital of Laredo Texas Withdrawn
Laredo, Texas, United States, 78041
Sponsors and Collaborators
Baylor Breast Care Center
AstraZeneca
Investigators
Principal Investigator: Mothaffar Rimawi, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00570323     History of Changes
Other Study ID Numbers: H 20431, PACT 001
Study First Received: December 6, 2007
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:
Breast Cancer
HORMONE RECEPTOR POSITIVE BREAST CANCER

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

ClinicalTrials.gov processed this record on July 26, 2014