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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00570323
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : March 4, 2019
Last Update Posted : July 28, 2020
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Drug: Arimidex Drug: Faslodex Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : December 2007
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: ARM A / Arimidex with Faslodex
Arimidex with Faslodex in postmenopausal women
Drug: Arimidex
Aromatase inhibitors
Other Name: Anastrozole

Drug: Faslodex
Hormone Receptor
Other Name: Fulvestrant

Active Comparator: ARM B Arimidex without Faslodex
Arimidex without Faslodex in postmenopausal women.
Drug: Arimidex
Aromatase inhibitors
Other Name: Anastrozole

Primary Outcome Measures :
  1. Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples [ Time Frame: baseline (pre) to day 28 (post) ]
    The primary endpoint is change in Ki-67 levels from baseline (pre) to day 28 (post) biopsy samples. Ki-67 levels were log-transformed to achieve approximately normally distributed data. The differences in these log-transformed values between post vs. pre biopsy samples were calculated. This difference represents the log of the ratio of post vs. pre Ki-67 levels in the original scale.

Secondary Outcome Measures :
  1. Clinical Response [ Time Frame: 1 Year ]
    Measurable lesions were examined at baseline to treatment completion.Clinical Response was defined by Solid Tumor Response Criteria (RECIST).

  2. Pathologic Complete Response [ Time Frame: 1 Year ]
    Pathologic response was defined as no residual invasive tumor on histopathological analysis in the breast primary. Patients were assessed according to the Chevallier classification of pathologic response.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570323

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mothaffar Rimawi
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Principal Investigator: Mothaffar Rimawi, MD Baylor College of Medicine
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Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00570323    
Other Study ID Numbers: H 20431
IRUSFULV0060 ( Other Identifier: AstraZeneca )
First Posted: December 10, 2007    Key Record Dates
Results First Posted: March 4, 2019
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action